Rapid Responses to:

EDITORIALS:
Neena Modi
Donor breast milk banking
BMJ 2006; 333: 1133-1134 [Full text]
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Rapid Responses published:

[Read Rapid Response] Erring on Mother Nature's side
James E Akre   (2 December 2006)
[Read Rapid Response] Donor breastmilk banking
Gillian A Weaver   (6 December 2006)
[Read Rapid Response] Donor breast milk - a suitable alternative
Dhruvashree Somasundara   (6 December 2006)
[Read Rapid Response] Donor breast milk banking- the developing world scenario
Peter Anthony McCormick   (8 December 2006)
[Read Rapid Response] Clinicians attitudes towards the use of donor milk.
Sergio Verd   (11 December 2006)

Erring on Mother Nature's side 2 December 2006
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James E Akre,
Author; Public Member, Board of Directors, International Board of Lactation Consultant Examiners
1232 Confignon, Geneva, Switzerland

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Re: Erring on Mother Nature's side

I find this editorial wanting on numerous grounds, including first and foremost its guilty-until-proved-innocent bias and its arch attitude as much toward Mother Nature as to all those "committed individuals" whose "altruism is undeniable".

I'm also exercised by its sloppy logical leaps, for example statements like:

"Unregulated expansion [of donor breast-milk banking] requires evidence of benefit" (does that imply that "regulated expansion" wouldn't require such evidence?);

"Donor human milk is not the optimal food for preterm growth" (so, in the absence of the milk of mothers delivering preterm, what's the optimal synthetic alternative then?);

"[increasing the protein and mineral content of donor milk] is an imprecise science as the composition of human milk is very variable" (Mother Nature screws up again and thank goodness we have those nice folks in long lab coats to provide us with "precise science");

"milk banks in the UK vary in size and operating procedures and are unregulated" (is this not an invitation for said banks to pull up their individual and collective socks rather than an indictment of their existence or the use of their "product"?);

"What evidence is there to support the use of donor breast milk?" (how much more evidence do we need of the risks involved in managing the nutritional needs of such kids any other way?);

"infant growth was slower" (uh, we're quite sure that slower is bad, right?);

"the role of donor milk remains to be established" (whereas we're of course entirely satisfied that the role of a synthetic alternative has been clearly established):

"donor milk is expensive" (managing a case of necrotizing enterocolitis is cheap, right?);

"These uncertainties are reflected in the divergent attitudes of clinicians towards the use of donor milk", which is an unreferenced quasi- non sequitur generalization followed by "and compounded by variations in acceptability by different communities", which - in an editorial whose primary focus is the UK - is backed by a single reference to research undertaken in north-central Nigeria.

By all means, let the research continue and may the relevant clinical guidelines always reflect objective evidence. But, sadly, the editorial's tentative either/or concluding recommendation - that "NHS resources might be better directed towards supporting mothers' own lactation" - automatically excludes a significant group of infants born preterm whose own mothers' milk is not available.

Collective experience confirms that any method of feeding these babies other than by using breast milk as the base ingredient is risky until shown otherwise. The burden of proof continues to rest on those who would suggest otherwise.

James Akre

Geneva, Switzerland

akrej@yahoo.com

Competing interests: None declared

Donor breastmilk banking 6 December 2006
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Gillian A Weaver,
Chair
United Kingdom Association for Milk Banking

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Re: Donor breastmilk banking

The call for evidence of benefit to support an unregulated expansion of human milk banks in the UK by Professor Neena Modi (BMJ vol333, 2 Dec 2006)) raises a number of points. The United Kingdom Association for Milk Banking (UKAMB) has been prominent amongst those asking for a regulatory system to support its own evidence based guidance (1). Nevertheless it is important to emphasise that questions exist about the safety of formula, particularly in relation to necrotising enterocolitis (2) when the mother is unable to provide breastmilk for her baby. The lack of data from randomised trials of sufficient size indicates that the current UK milk banking system (small banks mainly funded by individual NHS Trusts) has not been sufficient to support them despite a sufficiency of suitable donors willing to follow strict hygiene and lifestyle criteria.

Investment in a UK national system would enable donor breastmilk of optimal quality to be available according to need and not as is currently the case, according to the location of a child’s birth. Additionally, milk banking expertise would be retained and be capable of supporting other related research, for example on the safety and efficacy of breastmilk fortifiers. Globally milk banks are increasing in number and some countries are re-investing in donor milk banking despite having closed all the banks in the wake of the emergence of HIV (South Africa and Australia have recently announced the opening of their first milk banks since the 1980’s.) An International Milk Banking Initiative (IMBI) is currently mapping milk banking activity around the globe.

It is questionable to argue, as Professor Modi does, the closure of milk banks would result in a reallocation of NHS resources to increase support for breastfeeding mothers. These are different but complementary activities, both of which are worthwhile. Donor milk is always a second choice to the mother’s own milk. However its availability provides some support to mothers struggling to express sufficient milk for their babies in difficult circumstances.

Reference List

(1) United Kingdom Association for Milk Banking. Guidelines for the establishment and operation of milk banks in the UK. Third ed. London: UKAMB, 2003.

(2) Boyd CA, Quigley MA, Brocklehurst P. Donor breast milk versus infant formula for preterm infants: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed 2006;adc.

Competing interests: Chair - United Kingdom Association for Milk Banking

Donor breast milk - a suitable alternative 6 December 2006
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Dhruvashree Somasundara,
Ex- PRHO,
Bangalore Medical College, Bangalore-560001, India

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Re: Donor breast milk - a suitable alternative

The concept of Human milk banking was known in the UK since 1939, when the first Human milk bank was established in Queen Charlotte’s Hospital, London. However with the emergence of the Human Immunodeficiency Virus (HIV), these banks became less popular. In developing countries such as India, this concept is yet to gain popularity. A possible cause is the cost involved, keeping in mind the high birth rate.

An alternative to mother’s milk is looked for in situations where the mother is unwilling or unable to breast-feed. Donor breast milk and Formula feeds are the alternatives available. Donor breast milk may benefit infants1 in the following situations:

• Nutritional - Prematurity, Malabsorbtion syndromes, Failure to thrive, Bronchopulmonary dysplasia.
• Medicinal/Therapeutic Uses - Intractable diarrhoea, sepsis, pneumonia, gastroenteritis.
• Immunodeficiency diseases such as Severe Allergies and IgA deficiencies Preventative Uses - Necrotizing enterocolitis, during immune suppression therapy, Allergies, Crohn's disease.

Furthermore, those infants allergic to formula feeds have no other alternative to breast milk, either from the mother or from a donor. They need natural milk and breast milk from a donor would be the only option if the mother is not lactating.

A third alternative to mother’s breast milk is cow’s milk. Though cow’s milk has many of the nutrients of human milk, they are not present in the same proportion and would be rather harmful for the infant, especially preemies, as they would not be able to digest it. Infact, American Academy of Pediatrics recommends that mothers avoid giving their babies cow’s milk in the first year of life.

A guideline review article2 in “Archives of Disease in Childhood Education and Practice Edition” in 2004, lists the guidelines laid down by UK Association of Milk Banks. With such a regulated screening of breast milk donors and with hygienic collection and storage of milk, disease transmission would not be a major problem. However, each case must be individualised and the risk-benefit ratio considered. In addition, pasteurization of milk destroys both Cytomegalovirus and HIV. Some of the protective elements of milk might be destroyed during pasteurization but it will not be as deficient in these protective elements as formula feeds. The protective elements3 of breast milk are:

• sIgA: Protective protein that destroys bacteria
• Lactoferrin4: Proteins that slow bacteria growth. Lactoferrin from human milk can be absorbed to some extent by the infant and excreted in the infant's urine, though no reproducible published evidence has established any in vivo activity of lactoferrin
• Lysozyme: Enzymes that help break down food
• DHA & ARA: Fatty acids that aid in development

Breast milk is not restricted for use in infants alone. In a study by Hadar. J. Merhav et al6, breast milk was shown to decrease infections among adults who have undergone liver transplants. This is due to breast milk being a very rich source of IgA. Other important medical uses for breast milk are being investigated into.

The International Break Milk Project7 is proof enough of the importance of Breast milk banking. This is a project started from the United States to help the survival of infants orphaned by AIDS. The excess milk from lactating mothers is processed and shipped to Africa. This helps tackle the preventable causes of infant deaths.

Thus, with proper screening, hygienic collection, storage and dispensing of donor breast milk, the lives not only of many infants, but also of adults can be saved. Since formula feeds are not advisable for all infants for whom mother’s milk is not available, donor breast milk still has a place in the feeding of such infants. In addition, the potential of breast milk for use in organ transplant needs to be tapped by further research. What is necessary in addition to the above is generation of awareness and motivating lactating mothers to donate. Finally, I would completely agree with the author’s opinion that banking procedures need to be consistent for it to be used to its maximum potential and also be cost effective.

Reference:

1. “Banking on breast milk”: www.breastfeeding.com

2. Archives of Disease in Childhood Education and Practice Edition 2004; 89:ep27 “Guidelines for the establishment and operation of human milk banks in the UK”

3. Prolacta Bioscience

4. In vivo activities of lactoferrin, NIH guide, volume 23, number 14, april 8, 1994

5. American Academy of Pediatrics Vol. 108 No. 1 July 2001, p. e15

6. Transplantation International,Volume 8, Number 4 / July, 1995

7. www.breastmilkproject.org

Competing interests: None declared

Donor breast milk banking- the developing world scenario 8 December 2006
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Peter Anthony McCormick,
Volunteer children's physician
Cameroon

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Re: Donor breast milk banking- the developing world scenario

Rapid response to ; Editorials: Neena Modi; Donor breast milk banking BMJ 2006; 333: 1133-1134

Donor breastmilk banking: the developing world scenario

Professor Modi’s Editorial (BMJ 2006;333: 1133-4) would provoke a response from anyone concerned with the care of the newborn in the developing world; this in spite of the fact that she is concerned principally with the question of breast milk banking in the UK, (and its cost to the NHS), and Europe and USA, where formula feeding is safe and affordable, compared with the situation in sub-Saharan Africa. A balance needs to be struck with regard to the privileged few in the resource-rich world, and the overwhelming majority in the resource-poor world; between the NHS – with all its problems - and Africa with its fearful heartbreaking problems.

Pregnant women in Africa are often ill themselves, malnourished, anaemic, poor, uneducated, under-privileged, ill-informed, frightened, unempowered second-class citizens, and 50 times more likely than their contemporaries in the developed world to die as a direct and immediate result of their pregnancy 1. Their antenatal care may at best have been minimal, or more likely non-existent. Twenty percent of babies are preterm or small for dates, or both. The majority of these babies would have to wait until their mothers have established lactation. This would take much longer than the present guidelines stating that babies should be put to their mother’s breast within 30 minutes of birth 2

Many of Professor Modi’s statements are incontrovertible; we agree that preterm babies require a greater calorific intake than full-term babies; we agree that formula-fed babies gain weight quicker than breast- fed babies; we agree that fortifiers are of interest but lack scientific justification; we agree that HIV and cytomegalovirus (and other pathogens she does not enumerate) are transmissible by breastmilk; we agree that NEC risk is minimised by breast feeding, we agree that cultural, ethnic, tribal, and religious traditions can militate against us; and we agree that scientific trials are wanting as to the proof of the benefit alleged for donor breast milk.

We do not see in her piece the rightful emphasis that neonatal and infant death from diarrhoeal diseases 3, 4, 5 and respiratory infections 6,7,8 as a result of formula feeding, is a serious matter. We do not see that research into the best management of the newborn has always been a problem – even the important question of resuscitation of the newborn - and that as a result, it is the experience, observations and wisdom of colleagues in neonatology over recent decades, and particularly between 1957 and 1967, that have constituted our guidelines for all aspects of care of the newborn 9

Research for which Professor Modi rightly calls, has not been easy even in the developed world; how much more difficult in the developing world? I myself – having established 4 breast milk banks in Cameroon, C Africa – regret that I cannot produce statistics for outcomes 10. This however will not prevent me in the meantime, from pursuing breast milk banking in Cameroon. Every paper about donor breast milk banking is positive and encouraging (with the rather sad exception of Professor Modi’s Editorial), as has been advice to me from the United Kingdom Association for Milk Banking (UKAMB); and we know we are providing breast milk – albeit milk having been raised to 60ºC for 30 minutes – in the only way we can, according to our lights, for the benefit of our most fragile and vulnerable patients.

Professor Modi, under ‘Competing interests’ – is cited as being ‘chief investigator for planned and current trials involving newborn feeding’. I put the challenge to her, to propose a trial designed to investigate the short and long term benefits of donor breast milk for Cameroonian babies; randomised, controlled and double-blinded, of course. When she hears the unbelievable practical problems of initiating and sustaining such an investigation in rural Africa (where the neonatal, infant, under-5 and maternal mortality statistics are the worst in the world), she might well shrink from the challenge. I am waiting to hear from her.

Peter McCormick MB ChB DCH DTM&H
Volunteer Children’s Physician, Cameroon, Central Africa
Founder, Beryl Thyer Memorial Africa Trust
www.berylthyertrust.com
pa_mccormick@yahoo.com.

References:

1 Ronsmans C, Graham WJ. Maternal mortality: who, when, where, and why. Lancet 2006; 368: 1189-1200

2 www.babyfriendly.org.uk

3 Bhandari N, Bahl R, et al. Effect of community-based promotion of exclusive breastfeeding on diarrhoeal illness and growth. Lancet 2003; 361: 1418-1423

4 Feachem RG, Koblinski MA. Interventions for the control of diarrhoeal diseases among young children; promotion of breastfeeding. Bull WHO 1984; 62: 271: 271-291

5 WHO Collaboration Study Team on the role of breastfeeding in the prevention of infant mortality in less developed countries. Lancet 2000; 355: 451-455

6 Victoria CG, Smith PG, et al. Evidence for a strong protective effect of breastfeeding against infant deaths due to infectious diseases in Brasil. Lancet 1987; 2: 319-322

7 De Francisco A, Morris J, et al. Risk factors for mortality from acute lower respiratory tract infections in young Gambian children. Int J Epidemiol 1993; 22: 1174-1182

8 Resuscitation at Birth; Newborn Life Support Manual, Resuscitation Council (UK) 2001

9 McCormick PA, Establishing a Breast Milk Bank in a Cameroonian Hospital; Report for UKAMB. UKAMB News; August 2006

Competing interests: None declared

Clinicians attitudes towards the use of donor milk. 11 December 2006
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Sergio Verd,
Paediatrician.
Paediatric Clinic, Av. Alejandro Rosselló, 10 (07002 Palma de Mallorca) Baleares, Spain

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Re: Clinicians attitudes towards the use of donor milk.

I appreciate the editorial by Modi on milk banking (1). This is the first general medical journal that devotes an editorial to milk banking.

However, I question the authors' statement that “the extent to which pasteurised donor breast milk retains the biological properties of mother's milk is uncertain”. A number of papers have studied this topic since 1978; a summary of them was published in 2001 (2).

The next issue is “Human milk can transmit infection…transmission of CMV is not uncommon.... In contrast to blood banks, which are tightly regulated, human milk banks in the UK vary in size and operating procedures” There has been a unique outbreak of Pseudomonas aeruginosa in a neonatal unit caused by the contamination of a pasteuriser inappropriately used as a heater (3). It happened in France, where Milk Banks are regulated by law. Transmission of CMV has been reported from mother’s milk to her own baby and never from donor milk because after pasteurisation the milk does not contain any viable virus (4). On the other hand, Enterobacteriaceae have been identified in multiple reports associating bacterial colonization of dried formula with infection among infants fed these products (5). Prof. Modi states that donor milk is not pooled in the UK. I'm surprised because pooling was the rule in Britain. Individual raw milk is used seldom, for instance in Leipzig.

My last concern is the photograph of ten very big bottles, I hope they’re not ready for premature or sick neonates.

This in no way undermines the authors' crucial message that further research in this field is needed. A key point will be to convince parents to enter their babies in the trial, in spite of evidence that milk bank is associated with an 80% risk reduction of necrotising enterocolitis.

Sergio Verd, Paediatrician Paediatric Clinic, Av. Alejandro Rosselló, 10 07002 Palma de Mallorca, Spain sverd@telefonica.net

REFERENCES:

1. Modi N. Donor breast milk banking. Unregulated expansion requires evidence of benefit. Editorial. BMJ 20006; 333:1133-4.

2. Tully DB, Jones F, Tully MR. Donor milk: what's in it and what's not. J Hum Lact 2001;17:152-5.

3. Gras-Le Guen C, Lepelletier D, Debillon T, Gournay V, E Espaze E, Roze J C Contamination of a milk bank pasteuriser causing a Pseudomonas aeruginosa outbreak in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed 2003;88:F434.

4. Friis H, Andersen HK. Rate of inactivation of cytomegalovirus in raw banked milk during storage at -20 degrees C and pasteurisation. Br Med J (Clin Res Ed) 1982;285:1604-

5. Estrada B. Infections Associated With Powdered Infant Formula. Medscape Pediatrics. http://www.medscape.com/viewarticle/441218 (last time accessed 9th December, 2006).

Competing interests: None declared