Question about Combined Study Formula?

JK82

Just wondering if anybody on here has experience of the Combine Study for newborns? As part of this study we signed up to a formula study, where you receive a year's supply of either a standard formula or formula with added MFGM milk protein found in breast milk. You obviously don't know which one you get. We are just a bit apprehensive of it. The formula is made by one of the leading worldwide manufacturers.

cyning

This actually makes me so so angry op (not at you!!).

I have ethical issues with a formula company financing formula for a whole year where you don't know exactly what you are feeding your baby: with or without MFGM. Is this an extension of the study done in UCC/CUMH? If it is why are they extending it to the Coombe: why do they need more participants?

You don't actually need to answer those questions... I think if you are uncomfortable with it, that's probably your answer.

JK82

Thank you for the advice, I think both of our minds are made up now not to use it. I forgot to say in the original post that it is with Cumh/UCC that we were doing the study. I'm sure everything is perfectly fine with the formula they are offering but it's just the not knowing plus he is doing so well on the formula we have him on.

Keane2baMused

This is absolutely crazy for so many reasons.

Number 1 formula should not be offered where a mother is willing and able to breastfeed.

2. Formula is very expensive and may encourage those on low incomes who may be apprehensive about breast feeding to choose it instead.

3. Not all formulas suit all babies. You could go through a number of them to find the right one.

Cork2015!

I would run a mile from doing this, it sounds absolutely insane.

Who the heck do they think they are its not like the guess the shampoo campaign where we all tried it and found out a few months later what it was

I wouldn't dream of giving my baby something that i wasn't 100% of the ingredients etc.

This is actually madness and shouldn't be allowed

lazygal

This cannot be legal or ethical, surely?


It makes me so angry that a study like this would even be mentioned to parents. We really have a crazy attitude to breastfeeding in Ireland, but that's no surprise given how much money the dairy industry makes from it.

lazygal

JK82 wrote: »

Thank you for the advice, I think both of our minds are made up now not to use it. I forgot to say in the original post that it is with Cumh/UCC that we were doing the study. I'm sure everything is perfectly fine with the formula they are offering but it's just the not knowing plus he is doing so well on the formula we have him on.

It is illegal to promote formula feeding in any way, especially if claims about similarity to breastmilk are being made. I would ask you to tell CUMH and UCC to stop this immediately, and I'd report it to the HSE. I actually cannot believe a maternity hospital would collude with the formula industry in this manner.

cyning

http://www.infantcentre.ie/research/infant-maternal-nutrition-programme/combine-project/

I have no idea how I thought I read you were in Coombe op... Must have been tired!

It's not ethical. It just isn't. They aren't going comparing breastfeeding to formula they are going comparing formula to formula. No doubt in a few years we will see an ad on the telly saying closer to breastmilk again or some other such crap. I cannot believe that this is going on in a maternity hospital. I can just imagine someone struggling after night 2 being approached and being offered free formula for a year: I can't say I wouldn't have said no.

Also just to make perfectly clear this is not an attack on anyone's choice to bottlefeed. It's about the ethical considerations of approaching new parents and not letting them now exactly what they are giving their babies.

I am just disgusted this is going on.

lazygal

cyning wrote: »

http://www.infantcentre.ie/research/infant-maternal-nutrition-programme/combine-project/

I have no idea how I thought I read you were in Coombe op... Must have been tired!

It's not ethical. It just isn't. They aren't going comparing breastfeeding to formula they are going comparing formula to formula. No doubt in a few years we will see an ad on the telly saying closer to breastmilk again or some other such crap. I cannot believe that this is going on in a maternity hospital. I can just imagine someone struggling after night 2 being approached and being offered free formula for a year: I can't say I wouldn't have said no.

Also just to make perfectly clear this is not an attack on anyone's choice to bottlefeed. It's about the ethical considerations of approaching new parents and not letting them now exactly what they are giving their babies.

I am just disgusted this is going on.

I actually had to check out the study to make sure it was what I thought it was. CUHM should not be engaged in this type of activity.

Sligo1

I have no idea how this study was approved by an ethics comittee....

LegacyUser

At the risk of being controversial: some women are not able to breastfeed for various reasons. While I fully understand where posters here are coming from (Nestlé formula scandal springs to mind!), I honestly don't think it's a bad thing that companies attempt to improve formula so as to provide mothers and their babies with an alternative that is indeed as close as possible to breast milk.

I can see why not knowing what the formula contains can make people nervous, but I somehow doubt that most people feeding formula actually read and understand the list of ingredients of currently available formula. Some no doubt do, and I fully understand and appreciate concerns about putting babies at risk, I really do. On the other hand, for women in need formula could be argued to be a bit like medication for their babies. Think about it: nobody but the most desperate would choose to have their baby participate in clinical trials for new medication, yet we all want medication that is just right if our children end up sick. Unfortunately, in order to learn if something works and won't harm human children we don't really have any other options than to actually test stuff on them. Adults react differently, so they are useless for testing children's meds. I actually imagine that tests on babies are more often than not done on those that have run out of any other option, so on very sick, much more vulnerable babies than your average bouncing bundle of joy.

That must sound like I believe that new formula being tested on healthy babies in studies like this is a banal thing in comparison and should therefore be shrugged off. I don't. In fact, I wouldn't mind if formula was more treated like medication and only available in pharmacies. I just don't 100% share the outrage in this thread as I consider improving formula to be a good thing. I breastfed my child just fine, but had I not been able to, I would have wanted the very best alternative, as close to breast milk as possible. Therefore, I consider such studies and trials necessary and cannot point blankly call them unethical.

cyning

Money? Mead Johnson are a pretty huge company too... I normally don't pay much notice to this sort of thing but it just seems completely mad not to know what you are giving your baby.

lazygal

cyning wrote: »

Money? Mead Johnson are a pretty huge company too... I normally don't pay much notice to this sort of thing but it just seems completely mad not to know what you are giving your baby.

Had to assume the same, along with Ireland being a shamefully large exporter of infant formula.

Sligo1

DifferentAngle wrote: »

At the risk of being controversial: some women are not able to breastfeed for various reasons. While I fully understand where posters here are coming from (Nestlé formula scandal springs to mind!), I honestly don't think it's a bad thing that companies attempt to improve formula so as to provide mothers and their babies with an alternative that is indeed as close as possible to breast milk.

I can see why not knowing what the formula contains can make people nervous, but I somehow doubt that most people feeding formula actually read and understand the list of ingredients of currently available formula. Some no doubt do, and I fully understand and appreciate concerns about putting babies at risk, I really do. On the other hand, for women in need formula could be argued to be a bit like medication for their babies. Think about it: nobody but the most desperate would choose to have their baby participate in clinical trials for new medication, yet we all want medication that is just right if our children end up sick. Unfortunately, in order to learn if something works and won't harm human children we don't really have any other options than to actually test stuff on them. Adults react differently, so they are useless for testing children's meds. I actually imagine that tests on babies are more often than not done on those that have run out of any other option, so on very sick, much more vulnerable babies than your average bouncing bundle of joy.

That must sound like I believe that new formula being tested on healthy babies in studies like this is a banal thing in comparison and should therefore be shrugged off. I don't. In fact, I wouldn't mind if formula was more treated like medication and only available in pharmacies. I just don't 100% share the outrage in this thread as I consider improving formula to be a good thing. I breastfed my child just fine, but had I not been able to, I would have wanted the very best alternative, as close to breast milk as possible. Therefore, I consider such studies and trials necessary and cannot point blankly call them unethical.

While I agree with the majority of your points and how well you've articulated them there does seem to be something highly unethical with this study. I am a firm believer in evidenced based practice and clinical trials. And if this was something that was being "tested" on as you say, perhaps babies that really needed an alternative than I suppose the ethical stance would be highly negated.

However, this trial is on babies that don't necessarily need an alternative. Never mind an untested one. The ethical discussion would also be highly relevant in the circumstance you mention if a baby really did need an alternative formula. Well, with this trial... Your baby who may need the alternative may not in actual fact be getting it. This is where the ethics issues are. How is it ethical to withhold an alternative formula that a baby may in actual fact need...

There are so many uncertainties and this I believe is where the ethical issue arise.

pwurple

Is there any link beyond that headline blurb above?

I did the baseline study in CUMH which sounds somewhat similar... We had feeding charts to complete (including data on how long we breastfed for, or what formula was used. We also had tables to fill out around weaning, how much of each food, times of feeding etc. I was filling out those books for ages.

Then there were the samples etc.

So this study COMBINE (following IMPROvED) sounds a little like BASELINE (which followed SCOPE), but maybe more in depth? I would guess, because I don't actually have any information here at all, that if parents are not breastfeeding then they are being asked to use a specific formula and record data on it.

tinkerbell

DifferentAngle wrote: »

At the risk of being controversial: some women are not able to breastfeed for various reasons. While I fully understand where posters here are coming from (Nestlé formula scandal springs to mind!), I honestly don't think it's a bad thing that companies attempt to improve formula so as to provide mothers and their babies with an alternative that is indeed as close as possible to breast milk.

I can see why not knowing what the formula contains can make people nervous, but I somehow doubt that most people feeding formula actually read and understand the list of ingredients of currently available formula. Some no doubt do, and I fully understand and appreciate concerns about putting babies at risk, I really do. On the other hand, for women in need formula could be argued to be a bit like medication for their babies. Think about it: nobody but the most desperate would choose to have their baby participate in clinical trials for new medication, yet we all want medication that is just right if our children end up sick. Unfortunately, in order to learn if something works and won't harm human children we don't really have any other options than to actually test stuff on them. Adults react differently, so they are useless for testing children's meds. I actually imagine that tests on babies are more often than not done on those that have run out of any other option, so on very sick, much more vulnerable babies than your average bouncing bundle of joy.

That must sound like I believe that new formula being tested on healthy babies in studies like this is a banal thing in comparison and should therefore be shrugged off. I don't. In fact, I wouldn't mind if formula was more treated like medication and only available in pharmacies. I just don't 100% share the outrage in this thread as I consider improving formula to be a good thing. I breastfed my child just fine, but had I not been able to, I would have wanted the very best alternative, as close to breast milk as possible. Therefore, I consider such studies and trials necessary and cannot point blankly call them unethical.

Oh come on! "As close as possible to breastmilk" is a lie that is spouted by formula companies. It's not close at all to it. Formula will NEVER be even in the same galaxy as breastmilk - it cannot be replicated. Breastmilk is constantly changing, from feed to feed, from day to day, it has antibodies in it, hormones, growth factors, enzymes, things to fight viruses, parasites and allergies in it. Things that just cannot be manufactured in a factory. It really pisses me off when formula is described as close to breastmilk or "now even closer to breastmilk". No it's not, those are all lies, designed to fool parents into thinking it's just as good.

This study is just crazy - I cannot fathom how it's even permitted to carry out this study as it's giving away free formula. And I find it pretty sad that they are trying to convince parents to give their babies formula that they don't even know the name of so they can research it first. It's just wrong on so many levels.

jlm29

tinkerbell wrote: »

Oh come on! "As close as possible to breastmilk" is a lie that is spouted by formula companies. It's not close at all to it. Formula will NEVER be even in the same galaxy as breastmilk - it cannot be replicated. Breastmilk is constantly changing, from feed to feed, from day to day, it has antibodies in it, hormones, growth factors, enzymes, things to fight viruses, parasites and allergies in it. Things that just cannot be manufactured in a factory. It really pisses me off when formula is described as close to breastmilk or "now even closer to breastmilk". No it's not, those are all lies, designed to fool parents into thinking it's just as good.

This study is just crazy - I cannot fathom how it's even permitted to carry out this study as it's giving away free formula. And I find it pretty sad that they are trying to convince parents to give their babies formula that they don't even know the name of so they can research it first. It's just wrong on so many levels.

Yes. It's the free bit that's an issue I think. The unfortunate fact is that we have shockingly low breastfeeding rates in this country. There may be some increases in recent years, but then, perhaps it's to do with the circles I move in. I'm sure in other walks of life, I'd be classed as a weirdo for breastfeeding.
If people choose to formula feed, that's their choice, and it's fair enough, but there's no way they should be given the stuff for free. If people want to partake in a study, to improve formula quality etc, then let them buy the stuff for the same price as they would buy it in tesco. It's awful to think of a new mother, on the fence about breastfeeding being offered a years supply of free formula- if money is tight, it could easily sway her to the formula. I know breastfeeding can be free, but by and large it's not- on my first, I bought a decent pump, some breastfeeding friendly new clothes, nursing bras, pyjamas, I still bought bottles and a steriliser, I bought nipple cream, breast pads etc. id say all in, it probably cost the same as a years supply of formula. Everyone likes getting stuff for nothing, and if you're someone who will give breastfeeding a shot, but isn't too bothered about it, the free formula could totally suck you in.

cyning

pwurple wrote: »

Is there any link beyond that headline blurb above?

I did the baseline study in CUMH which sounds somewhat similar... We had feeding charts to complete (including data on how long we breastfed for, or what formula was used. We also had tables to fill out around weaning, how much of each food, times of feeding etc. I was filling out those books for ages.

Then there were the samples etc.

So this study COMBINE (following IMPROvED) sounds a little like BASELINE (which followed SCOPE), but maybe more in depth? I would guess, because I don't actually have any information here at all, that if parents are not breastfeeding then they are being asked to use a specific formula and record data on it.

I think that is the case: once they choose not to breastfeed they are asked about this study.

But the difference in the study you were on is that was formula you chose to use, or breastfed as you chose. Giving food you picked. It's not handing out 12 months worth of free formula which may or may not have an ingredient that isn't currently available in formula on the market?

Giving out free formula is just not ok. So imagine someone from a poorer socio economic background is on this formula. It's not entirely suiting their baby: nothing serious, just colicky mild reflux etc. It is going to be a MASSIVE deal for that family to change the formula as what they are getting is free and they will have to pay for the new formula. They are going to be less inclined to change as things aren't very bad. Even though it may not be quite right for their baby. That's not ethical.

Trials and studies are of course needed: without a doubt. I don't dispute that for one second. It's the free formula for a year I have major, major issues with. It's financed by mead Johnson: so if enfamil doesn't suit your baby and sma/Aptamil would they analyse that?

Unbiased studies are needed. Not a study on new ingredients for formula paid for by a specific formula company.

Keane2baMused

DifferentAngle wrote: »

At the risk of being controversial: some women are not able to breastfeed for various reasons. While I fully understand where posters here are coming from (Nestlé formula scandal springs to mind!), I honestly don't think it's a bad thing that companies attempt to improve formula so as to provide mothers and their babies with an alternative that is indeed as close as possible to breast milk.

I can see why not knowing what the formula contains can make people nervous, but I somehow doubt that most people feeding formula actually read and understand the list of ingredients of currently available formula. Some no doubt do, and I fully understand and appreciate concerns about putting babies at risk, I really do. On the other hand, for women in need formula could be argued to be a bit like medication for their babies. Think about it: nobody but the most desperate would choose to have their baby participate in clinical trials for new medication, yet we all want medication that is just right if our children end up sick. Unfortunately, in order to learn if something works and won't harm human children we don't really have any other options than to actually test stuff on them. Adults react differently, so they are useless for testing children's meds. I actually imagine that tests on babies are more often than not done on those that have run out of any other option, so on very sick, much more vulnerable babies than your average bouncing bundle of joy.

That must sound like I believe that new formula being tested on healthy babies in studies like this is a banal thing in comparison and should therefore be shrugged off. I don't. In fact, I wouldn't mind if formula was more treated like medication and only available in pharmacies. I just don't 100% share the outrage in this thread as I consider improving formula to be a good thing. I breastfed my child just fine, but had I not been able to, I would have wanted the very best alternative, as close to breast milk as possible. Therefore, I consider such studies and trials necessary and cannot point blankly call them unethical.

I agree to the extent,and there's no doubting there should be efforts made to improve the quality of formula.

I think to say it's unethical is far stretching. These formulas are clearly going to be perfectly safe for babies but I imagine they are going to see how effective whatever extra supplementation the trial can give.

It's not akin to giving a child a very experimental drug where side effects are unknown. It shouldn't be treated like for like and I am very much of the 'breast is best' (where possible) mind set.

pwurple

cyning wrote: »

pwurple wrote: »

Is there any link beyond that headline blurb above?

I did the baseline study in CUMH which sounds somewhat similar... We had feeding charts to complete (including data on how long we breastfed for, or what formula was used. We also had tables to fill out around weaning, how much of each food, times of feeding etc. I was filling out those books for ages.

Then there were the samples etc.

So this study COMBINE (following IMPROvED) sounds a little like BASELINE (which followed SCOPE), but maybe more in depth? I would guess, because I don't actually have any information here at all, that if parents are not breastfeeding then they are being asked to use a specific formula and record data on it.

I think that is the case: once they choose not to breastfeed they are asked about this study.

But the difference in the study you were on is that was formula you chose to use, or breastfed as you chose. Giving food you picked. It's not handing out 12 months worth of free formula which may or may not have an ingredient that isn't currently available in formula on the market?

Giving out free formula is just not ok. So imagine someone from a poorer socio economic background is on this formula. It's not entirely suiting their baby: nothing serious, just colicky mild reflux etc. It is going to be a MASSIVE deal for that family to change the formula as what they are getting is free and they will have to pay for the new formula. They are going to be less inclined to change as things aren't very bad. Even though it may not be quite right for their baby. That's not ethical.

Trials and studies are of course needed: without a doubt. I don't dispute that for one second. It's the free formula for a year I have major, major issues with. It's financed by mead Johnson: so if enfamil doesn't suit your baby and sma/Aptamil would they analyse that?

Unbiased studies are needed. Not a study on new ingredients for formula paid for by a specific formula company.

You may indeed be correct, but I'm saying is we don't have enough information here to make that judgement. There are a few assumptions being made.

You don't know how this study is set up, neither do I. But I do have some background in being on a study run by the same dept, and on that, there was an ethics review and breastfeeding was strongly supported.

All I know of this study from the link is that it is:
1) Limited to parents of children who have already completed the pregnancy study
2) Primparous women only
3) Limited to CUMH

It's a small pre-selected group, who have already completed another study during pregnancy. These post-study follow-ons tend to be self-selecting, generally women from poorer socio-economic groups do not complete them. So it's not a case of the group going down to the local supermarket in ballyphehane passing out free formula.

Also, for any study, where someone is being asked to try a specific product, it is provided for them, so that batch numbers are recorded and traceability is maintained. There well may be a conflict here, free formula I have a problem with too, but asking a trial group to pay for it brings another layer of complication.

I will see if I can get further information on it...

pwurple

Ok, bit more here:
http://www.infantcentre.ie/research/infant-maternal-nutrition-programme/combine-project/combineformulastudy/

The COMBINE Infant Formula Study is a study within the COMBINE Cohort Study
The study will explore whether the MFGM protein, found naturally in breastmilk, could benefit formula-fed babies. Recent research has suggested that this protein is important for healthy brain development and formula products that are currently available do not contain this protein. This trial will assess whether adding the protein improves the nutritional content of infant formula.
The babies enrolled on the trial will be part of a randomised control study trial (the gold standard for clinical trial research). They will be provided with either standard Mead Johnson Nutrition formula or the same formula with added MFGM protein. The formula will be provided free of charge to the families participating. We provide the formula in order to record all batch numbers and maintain traceability. Both formulas meet all CODEX and EFSA European safety standards. This trial has full ethical approval and all mothers participating give informed consent.
Both the INFANT Research Centre and CUMH advocate breastfeeding at all times: we know breast is best .
Nevertheless, for a variety of reasons, some mothers cannot, or choose not to, breastfeed. We firmly believe that babies who receive formula should receive the best possible product, and research such as this is very important.
The COMBINE Infant Formula Study is ONLY open to mothers who already exclusively formula feed their babies. The babies will have all the COMBINE check-ups for the 12 months they are using the formula and the following year. If, for any reason, mothers decide they no longer wish to continue with the formula study, they can withdraw at any time without it affecting their participation in the COMBINE Cohort Study.
The results of the infant formula will be made publicly available. We hope that this research will lead to policy change and the enhancement of all infant formula, regardless of the brand.

If you would like any further information, please contact the team on combine@ucc.ie

For more information on Clinical Trials, click here
For more information on Mead Johnson Nutrition, click here
For more information on infant formula safety standards, click here

mirrorwall14

I don't fully get the outrage here though a poster has articulated it better than me. I couldn't breast feed. Not that I failed, not that I didn't want to try but for my own medical reasons I could not breastfeed. I knew this from early on in my pregnancy as my medications are not permitted when breastfeeding. Coming off them for pregnancy was risky enough.

As someone who HAS to use formula I do want the companies to be sure that the formula I use is the best possible formula. That requires studies to be done and if a mother is putting in the work, doing the surveys, feedback etc for the company in question I would argue its normal to get compensation be it in the form of free formula or other

pwurple

mirrorwall14 wrote: »

That requires studies to be done and if a mother is putting in the work, doing the surveys, feedback etc for the company in question I would argue its normal to get compensation be it in the form of free formula or other

It's not actually seen as compensation. The formula is provided by the study so that they can track all the batch numbers used in the trial. This is how trials are normally run.

mirrorwall14

pwurple wrote: »

It's not actually seen as compensation. The formula is provided by the study so that they can track all the batch numbers used in the trial. This is how trials are normally run.

That actually makes even more sense

tinkerbell

It is not ethical to give free formula. Those who participate in the study should have to pay for the formula in the same way as they would normally if they weren't participating in the study. You're not meant to switch formula and it would sway people already formula feeding to move to the Mead Johnson formula instead or if their babies didn't take to the formula in the study, there may be some parents who would continue on using it because it's free.

The reason formula is so expensive is because of all the advertising. Unfortunately, Ireland has not fully implemented the WHO code which bans ALL formula advertising and instead, Ireland only ban stage 1 formula. You are constantly bombarded with advertising on TV, magazines, etc. If it were banned, the price would come down. Is it any wonder when we are one of the largest exporters of infant formula? :rolleyes:

Mirrorwall - sorry to hear you couldn't breastfeed for medical reasons. Just for others reading the thread, it's a good idea to reference the Breastfeeding Network in order to check if the medication you are on is compatible with breastfeeding. Most medications are actually compatible, it is a minor few that aren't compatible. Most medical professionals don't know enough about the safety of drugs in breastmilk since it's a specialised area so advise breastfeeding isn't recommended when in reality, there isn't an issue.

www.breastfeedingnetwork.org.uk

mirrorwall14

tinkerbell wrote: »

It is not ethical to give free formula. Those who participate in the study should have to pay for the formula in the same way as they would normally if they weren't participating in the study. You're not meant to switch formula and it would sway people already formula feeding to move to the Mead Johnson formula instead or if their babies didn't take to the formula in the study, there may be some parents who would continue on using it because it's free.

The reason formula is so expensive is because of all the advertising. Unfortunately, Ireland has not fully implemented the WHO code which bans ALL formula advertising and instead, Ireland only ban stage 1 formula. You are constantly bombarded with advertising on TV, magazines, etc. If it were banned, the price would come down. Is it any wonder when we are one of the largest exporters of infant formula? :rolleyes:

Mirrorwall - sorry to hear you couldn't breastfeed for medical reasons. Just for others reading the thread, it's a good idea to reference the Breastfeeding Network in order to check if the medication you are on is compatible with breastfeeding. Most medications are actually compatible, it is a minor few that aren't compatible. Most medical professionals don't know enough about the safety of drugs in breastmilk since it's a specialised area so advise breastfeeding isn't recommended when in reality, there isn't an issue.

www.breastfeedingnetwork.org.uk

It's a good reference. I knew alright, had done my research beforehand myself

dekey

What about those that sign up for the study because money is tight and there's the promise of free formula for a year and a few weeks in it doesn't look like it's agreeing with baby. Most parents would look to change formula to another brand to see if it suits better. I guarantee the formula company sponsoring the study (because they care about providing the best nutrition for babies) won't see their free formula promise through if it doesn't serve some purpose to lining their already heaving pockets at some stage in the future and certainly wouldn't encourage a move to one of their competitors.

I know the abstract says they are only targeting (I think this is the perfect word!) those that have already indicated their intention to formula feed but it really goes to show that the study is for the ultimate benefit of Mead Johnson rather than the benefit of babies.

Also, given that my breastmilk today may be of a different constitution than it was yesterday and is completely different to Mary from next doors milk it will never be possible for any substitute to closely resemble breastmilk.

Babies suffer side effects from formula regularly. There has been media coverage lately of a well known brand that changed its ingredients recently and caused many children to be admitted to hospital because they were being poisoned. For this reason and many others I think it's unethical and irresponsible for a maternity hospital to participate in these trials

tinkerbell

mirrorwall14 wrote: »

It's a good reference. I knew alright, had done my research beforehand myself

Yeah I assumed yours was correctly advised since you mentioned coming off them for pregnancy was risky.

Tis crazy though the way some doctors tell women to stop breastfeeding just because they haven't referenced it themselves.