Monday, September 17, 2007

Missing from formula - will insulin be the next 'closer to breastmilk' claim?

There is a race that I have represented a few times when I have been invited to speak at health worker conferences. It is the race between formulas to appear the best. One says it is 'closer to breastmilk', another 'inspired by breastmilk', another 'closest to breastmilk'. They boast of ingredients for eye and brain development, building the immune system and so on. When I look at what the companies say I just end up confused as to who to believe. They can't all be better than their competitors, but that is what the pseudo science in their promotional materials suggests. See:

In my representation of the race (which you can hear by clicking here), the different formulas are jostling for position, diverting attention from breastmilk, way out in front. Not only does breastmilk have many times the number of 'prebiotics' (oligosaccharides) than formulas that boast of them, they are those a child needs. Breastmilk has Long Chain Polyunsaturated Fatty Acids and, unlike those in formula, they do actually appear to benefit brain and eye development. While powdered infant formula is not sterile and may contain pathogens such as Enterobacter Sakazakii and Salmonella (requiring care in preparation), breastmilk is not sterile because it is a living substance containing anti-infective properties produced by the mother in response to infections in the environment. Breastmilk is like a dose of medicine every time the child is fed.

But that is not all. Breastmilk contains factor X. Something not yet identified, but is perhaps important for the benefits breastfed children gain. Then there is factor Y, which has been identified, but cannot yet be simulated in the laboratory or in a cost-effective way to add to formula. Then we have factor Z, which can be simulated and added to formula, but does not have the same effect in the different environment of formula. LCPs are one example, but there are others, such as iron. Formula has far higher levels of iron because most of it is not absorbed by the child from formula. Virtually all of the iron in breastmilk is absorbed.

So breastmilk is way out in front in the race, but all the shouting is being done by the companies with their products in the pack behind. Which is the best? Which is the closest? They want to keep the attention focused on that part of the race.

If breastfeeding is not an option, if expressed or donor milk is not available, if wet-nursing is not culturally acceptable or discounted for safety reasons, then formula is the next best option. It is a legitimate product and we are not saying it should be banned. But it should be seen as what it is. An artificial substitute for a natural substance. The aggressive marketing generates a different perception. It suggests formula is hot on the heels of breastmilk and we should be cheering for it. "Love the milk you give" is the slogan of one of the companies in the UK.

I can imagine a diabetic using artificial insulin may love the fact it is available if he or she cannot produce his or her own. But I wouldn't want to see artificial insulin promoted on television and in celebrity magazines with a 'love the insulin you give' slogan and pictures of happy people and cuddly toys. I wouldn't want company produced materials causing me to doubt if I am producing enough insulin myself, suggesting symptoms that could indicate my insulin isn't up to the job and suggesting a little insulin supplementation may be a good idea. I wouldn't want a vocal advertising war over which artificial insulin is 'the closest to real insulin'. Certainly, I'd be grateful if it was available if I needed it, but I'd rather have my own insulin production system well checked out and medical advice before deciding I did need it or which brand to use.

Insulin is very relevant to this topic, because it is a missing factor in formula according to a recent report. This is from Israel21c:

---Extract begins
In the first 24 hours of life, a nursing baby gets a big zing of power from its mother's milk. "This is a mother's first gift to her child," says Professor Naim Shehadeh, head of the Pediatric Diabetes Clinic at the Rambam Medical Center in Haifa, describing the nutrients and vitamins that mother's milk provides the newborn.

Especially insulin.

"Insulin is 100 times more concentrated in the first milk a mother gives her baby than in the blood. Nature must have a reason for enriching the first milk and helping the newborn get over the shock of the first 24 hours," explains Shehadeh, who specializes in pediatrics and endocrinology, and is also on the faculty of the Technion Institute Medical School.

Now get this:

Formula does not contain insulin.

Infants who are formula-fed are more likely to suffer from diabetes in later life.

These facts may be totally unconnected, but you can see they would make a great marketing campaign for a 'new improved' infant formula.

I've not looked into this thoroughly yet, but a microbiologist tells me that insulin-type growth factors in breastmilk are thought to be important for gut development and could be part of the reason why infants not fed breastmilk, particularly premature babies, are at greater risk of necrotising enterocolitis, an illness where the gut does not develop the blood vessels it needs, meaning the child cannot absorb food properly. NEC, as it is known, can be deadly, but it is a more immediate problem than diabetes.

All the same, the report goes on:

---quote begins
An expert in juvenile diabetes, Shehadeh and others observed the higher incidence of the disease among children who had not been breastfed.

"An alarm went off in my head," he told ISRAEL21c, and the first seed was planted for an idea for a formula for non-breast-fed babies that would come closer to the benefits of mother's milk - specifically the massive amounts of natural insulin found in mother's nectar.
---quote ends

So guess what may be just around the corner. Infant formula with insulin: "The result of that alarm is InsuMeal, a bioactive insulin protein that can be added to commercial infant formulas to make them closer to mother's milk."

Remember what market analysts Hambrecht and Quist said about Formulaid, the concoction of Long Chain Polyunsaturated Fatty Acids put on the market in the 1990s:

---Quote begins
The history of infant formula has shown that virtually all similar examples have led to wide-scale introduction of such additives into infant formula, even if there was no evidence that the additives were important. Infant formula is currently a commodity market with all products being almost identical and marketers competing intensely to differentiate their product. Even if Formulaid had no benefit we think that it would be widely incorporated into most formulas as a marketing tool and to allow companies to promote their formula as 'closest to human milk.'
---quote ends

Things could go the same way with InsuMeal.

There is a problem, however, as the article explains:

---Quote begins
"We looked on the market and we did not find any baby formula with insulin. It was lacking in all," said Shehadeh. "The reason insulin is not in formula, is because it is very sensitive to heat and mechanical stress, and usually destroyed in formulas. We developed a new technology to keep the insulin bioactive. We also have a usage patent."
---quote ends

You may recall that most companies are failing to warn parents that powdered infant formula is not sterile and the need for a high temperature step in reconstituting it to kill any pathogens. Some companies directly contradict the expert guidance to parents from the World Health Organisation. See:

We believe part of the reluctance is that new additives just around the corner, such as so-called probiotics and perhaps this insulin supplement, may be damaged by high temperatures. Perhaps the companies don't want parents to get used to using water above 70 deg. C to kill possible bacteria contamination because it would undermine their marketing claims about these new additives when they come if they would also be damaged.

There is a debate to be had over whether the benefits of new additives is greater than the risk from pathogens. For that there needs to be careful research.

Unfortunately, the proposed regulations currently out for consultation in the UK will allow companies to add new ingredients and launch new products onto the market without proving the safety or necessity of new ingredients.

In the government's proposals, companies simply have to submit a model of the label they plan to use to be held on file. That's it.

We are saying companies should submit research studies, much of it independently funded and conducted, and that these should be independently reviewed. If new ingredients are found to be safe and necessary for infant development, then they should be a legal requirement in all formulas.

For infants who are not breastfed, we are talking about the sole food during the most important phase of development outside the womb. Formula should be as good and as safe as possible.

You can support our campaign to make formula safer and sign up for updates at:

At the moment the claims around InsuMeal are hype, based on a study of 8 infants. The report continues:

---Quote begins
"We believe that InsuMeal is a vital nutritional supplement. When the results of the forthcoming clinical trials are published, and the health benefits demonstrated, we will need a manufacturing base ready to meet the demand," said Shehadeh. China and India - where formula growth has been particularly high - are expected to be big demand markets.
---quote ends

The global wholesale market for infant formula is valued at US$8.5 to 9.5 billion in the article.

So what have we learned?

These 'closer to breastmilk' formulas on the market are now revealed to be missing insulin, according to this report. Why wasn't that mentioned in the company promotions?

What about factors X, Y and Z.

We have also seen that jumps in logic are made without real basis. Breastmilk has insulin. Breastfed babies are less likely to suffer from diabetes. Ergo, alarm goes off and potential big demand is spotted. The trials to show safety and health benefits are still to be done and the company is seeking investors to pay for these and the marketing, creating a conflict of interest.

In the race between formulas to appear the best and closest to breastmilk, look out for a new slogans in the years to come.

"Love the insulin you give", perhaps.

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