Friday, September 07, 2007

Information about formula should be based on independent science

I wrote yesterday how an independent review of studies on the impact of adding Long Chain Polyunsaturated Fatty Acids (LCPUFAs) to formula found: "At present there is little evidence from randomised trials of LCPUFA supplementation to support the hypothesis that LCPUFA supplementation confers a benefit for visual or general development of term infants".

Claims that formulas with added LCPUFAs benefit brain and eye development are widespread. We have exposed how Nestlé promotes its formula with the claim it contains 'brain building blocks' and yesterday I was looking at Mead Johnson promotion for its Enfamil Lipil formula in the US and UK.

We receive monitoring reports from the US from time-to-time from mothers who have received a crate of formula at home from a company without any request for it. Samples and free supplies are prohibited by the International Code of Marketing of Breastmilk Substitutes. They undermine breastfeeding.

Imagine if you are at home with your new child of two or three weeks. You have sore nipples and your child who isn't latching on well is hungry and crying. You are in pain, frustrated and concerned that your child is not getting the sustenance needed. You're about to reach for the phone book to find a lactation consultant who you hope can help you through this difficult period when there is a knock at the door. It's a crate of formula. Not only does the thought of switching to formula offer immediate relief and an end to your baby's crying, a quick check into the formula shows you it claims it will actually help the brain and eye development of your child. You know 'breast is best', but the formula claims to be based on breastmilk and close to breastmilk. You may well take the totally understandable decision to believe what the company says and forget about calling the lactation consultant.

It is for a mother how to decide how to feed her child. However, a mother has the right to make that decision based on accurate information free from pressure from companies who have a vested interest in selling their product. The first crate of formula may be free, but once the child is on formula and a mother's milk has dried up, she is a captive consumer, unless she can obtain help with relactating.

We don't want to see mothers being forced to suffer if they experience difficulties with breastfeeding, but nor do we want to see companies targeting mothers, particularly during the time when breastfeeding is being established. We want there to be better support for mothers and, if she decides to use formula, accurate, independent information on the differences between the brands on the market and how to reduce the risks of formula feeding. That is achieved in part through implementing and enforcing the International Code of Marketing of Breastmilk Substitutes and subsequent, relevant Resolutions of the World Health Assembly.

Now, how could the crate of formula have magically appeared on the doorstep at the time when a mother is feeling most vulnerable? Well, in some cases it could have come from the health worker calling the company to register the birth.

In 2002 Mead Johnson ran a promotion for babies born on Labour Day. See:

---Extract from Mead Johnson promotional information
For every woman giving birth on Labor Day 2002, Mead Johnson Nutritionals will provide them with a FREE case of its new infant formula, Enfamil(R) LIPIL(R) with Iron. Enfamil LIPIL is the only infant formula in the United States that contains DHA and ARA - important building blocks of a baby's brains and eyes that are found naturally in breast milk - at levels clinically demonstrated to support brain and eye development in infants vs. the same formula without DHA or ARA. LIPIL is Enfamil's unique blend of DHA and ARA.

"We are committed to helping all infants get the best possible start nutritionally," said J. Roberto Moran, MD, Vice President and Medical Director for Mead Johnson Nutritionals, "We fully believe that breastfeeding is ideal for babies - breast-fed babies receive the benefits of DHA and ARA from their mother's milk. For moms who choose to use formula - either right from birth, following weaning from breast milk or as a supplement to breastfeeding -- Enfamil LIPIL is a great option."

Studies Show Benefits of LIPIL

---quote ends

Mothers could register themselves or: "Healthcare professionals can also call **** or send a fax to **** to provide the baby's birth date (it must be September 2, 2002) and provide shipping information. Mead Johnson will send a case of free Enfamil LIPIL formula right to parents' doorsteps."

Generous, huh?

But what about the studies that Mead Johnson claims prove the benefit of its formula?

According to the Cochrane Library review of studies, quoted at the start, there is little evidence of any benefit.

Let me just say if there was a benefit then we would want to see LCPUFAs in every tin of formula. Why should the health of infants fed with formula be compromised further by denying essential ingredients? But when the European Scientific Committee examined whether LCPUFAs should be made essential ingredients it concluded there was no need to do so as there was no apparent benefit from adding them. We defer to the independent experts.

So what about the research referred to by Mead Johnson? This is what is says in the promotional information:

---Quote begins

Enfamil LIPIL has been shown in some studies to support infant brain and eye development when compared to the same formula without DHA and ARA. One study led by Eileen Birch, PhD, of the Retina Foundation of the Southwest and funded by the National Institute of Child Health and Human Development found that infants fed Enfamil LIPIL from birth to four months scored an average of seven points higher (on a 100-point scale) on a test of mental development at 18-months compared to infants fed the same formula without DHA and ARA. The study also showed improved visual acuity equal to about one line on a standard eye chart in the one-year-old infants fed Enfamil LIPIL.

---quote ends

Wow! Branier kids with better eye sight, if this can be believed.

Interesting, but presumably one of the studies considered in the Cochrane Review. Mead Johnson's use of the phrasing 'shown in some studies' reveals that the research is not conclusive.

But what about this study? It was, so it says, funded by the National Institute of Child Health and Human Development.

It seems it is this study: "Eileen E Birch et al. A randomized controlled trial of early dietary supply of longchain polyunsaturated fatty acids and mental development in term infants. Developmental Medicine & Child Neurology 2000, 42: 174–181."

Available here:

I am not going to attempt a critical appraisal of it here. I defer to the Cochrane Library review on the benefits, or otherwise, of LCPUFA supplementation.

But I note a few very interesting points in the study not mentioned in the Mead Johnson promotional information.

Firstly, "Milk-based infant formulas were generously provided by the Mead Johnson Nutritional Center".

Okay, perhaps we can say that was nice of them and would have no influence. It was, after all, funded independently other than this wasn't it?


"This project was supported by NIH grant HD22380 and supplementary funding was provided by the Mead Johnson Nutritional Center."

Okay, so Mead Johnson was a funder, but they couldn't have had any influence on the reseach could they?

"A blocked randomization schedule was developed by the Mead Johnson Research Center (Evansville, IN) and provided in sealed envelopes to the study site."

Okay, so they provided the formula, some funding and the schedule for the study.

But, all the same, it could be a good study. It's just not independent, is it?

The researcher is from the Retina Foundation of the Southwest which, according to its website, is: "an independent, nonprofit institution whose mission is to optimize sight by conducting research to understand, treat, and prevent blinding eye diseases, and to disseminate information thereon."

I am not about to question the work the Foundation does. I am happy to presume there are committed people doing their best to make a positive difference in this area.

But I will examine the claim to be independent by looking at the list of funders.

I guess you can see what is coming?

There in the Year Report 2006 is Mead Johnson.

Draw this all together and we have claims made by a company to promote its product that are not substantiated by an independent review of the evidence. A study that does appear to support the company's claims was provided with free formula by the company, part-funded by the company and provided with schedule data by the company. It was conducted by an organisation that receives other financial support from the company.

My conclusion is this: this is not the way to provide information to parents and health workers.

There needs to be independent and accurate information. Any claims should be based on independent science.

That is not only my point of view. The World Health Assembly has adopted Resolutions calling for care over conflicts of interest for health workers in the area of infant feeding. See the May 2005 Resolution WHA 58.32.

I think we would be wise to avoid conflicts of interest and should call on our policy makers to implement the International Code and Resolutions in independently monitored and enforced legislation.

What do you think?

If you want to defend a mother's right to independent and accurate information in the UK, please support our 'Making formula feeding safer' campaign:

No comments: