Letter on local v imported therapeutic milk, by Rebecca Norton and Jean-Pierre Papart (with responses by Mike Golden, Ann Ashworth, Mary Lung'aho and David Sanders)

Recently, ENN was party to an exchange of questions and discussion between field staff and 'experts' relating to decisions on the use of readymade therapeutic products versus those made from modular ingredients in the management of severe malnutrition. Those involved have agreed to share this exchange with the Field Exchange readership as they feel this is an issue that needs 'airing'. The ENN would welcome contributions from the Field Exchange readership on this topic. Email any comments to marie@ennonline.net (eds).

Questions from the field

Fondation Terre des hommes (Fondation Tdh) is a Swiss based non-governmental organisation (NGO) that supports the treatment of acute severe malnutrition in a hospital in Nouakchott, Mauritania. A recent field trip led to a query over whether the use of Nutriset F100 and F75 'ready made' products over the use of therapeutic milks made up from oil, milk, sugar and CMV therapeutic was advised, and if so why. This letter was directed by Fondation Tdh to Mike Golden as an expert on the management of severe malnutrition who had recently returned from Mauritania, therefore having a good understanding of the context being discussed.

Dear Mike,
Currently Fondation Tdh provides dry skimmed milk and CMV Therapeutic to the hospital to make up therapeutic milk. Oil, sugar and flour are bought locally. We are concerned that in a non-emergency setting like Mauritania, use of ready-made products risks creating a large-scale dependency on expensive externally imported products. What happens if the funding stops? Also, ready-made products diminish the importance of the role of the kitchen in the treatment of severe malnutrition - still necessary for preparing complementary foods for phase 2, but will this also be undermined if modular feeds are no longer needed? We also have concerns about the environmental aspect of their use and the problems with ensuring a continuous flow of products.

Many may be wondering if the reason for our concern relates to the fact that we provide milk (Swiss made!). But this really is not relevant. Milk could be obtained locally and it is not too expensive. Of course there would have to be a quality assurance system in place to ensure that the locally obtained milk is safe for use in therapeutic milks.

Are ready formulated products less error prone, and much easier to use?

What about the long-term sustainability issues in non-emergency contexts?

Do patents on products mean there is a monopoly on their production? And ultimately what should we advocate as an NGO working in this context - continue to push for locally made mixes with imported added CMV Therapeutic (as we currently do) or go for the more ready-to-use alternative?

Our gut feeling is towards the more 'sustainable' option - modular feeds - but the answer is not clearcut and we would really appreciate your feedback on this.

Regards, Rebecca Norton and Jean-Pierre Papart
Nutrition/health advisors, Fondation Tdh

Response

Dear Rebecca,
You are not alone and the questions that you raise recur in most countries. There are several issues here.

Ingredients

Home-made products have a higher than desirable osmolarity, especially F75 made up with sugar alone, and can induce diarrhoea in a few children - the sickest being the most vulnerable to this. Quality control is difficult to achieve using modular feeds. (This may be due to wrong recipes being used, incorrect scoops, excess amounts of CMV therapeutic being added, inaccurate translation of measurements into 'local' measures using cups, etc, careless measuring and lack of supervision).

There is also variability in the products used. All oil is not the same - while the commercial product is governed by strict specifications in terms of fatty acid, vitamin and sodium content, this is not the same for the modular feed where in practice, most will go to the market and get the cheapest oil available. The peroxide level of the fat is also important, vegetable oils easily become rancid generating high peroxide levels that place at risk children who have very little in the way of anti-oxidants. Similarly, locally sourced Dried Skimmed Milk (DSM) may not meet the low sodium and iron specification that commerical manufacturers source to make therapeutic milk.

At one level, one can "get away" with using any local ingredients and the differences in the recovery of the children are likely to be quite subtle. But the risk is we are falling way short of the recovery we know we achieve with the modern (commercial) diets.

There are actually advantages of not having to rely on a kitchen to prepare milk, like you need with the modular feeds. Therapeutic milk can be prepared as needed (e.g. during the night) and in facilities without kitchens or additional staff, but that otherwise have the capacity to manage severely malnourished children, such as in health centres. Stock control is also an issue when ingredients have a household use and are of 'interest' to workers. Empty packets of F75/F100 that are returned to the pharmacy is a more secure control system, than trying to monitor usage of milk powder, sugar and oil.

Sustainability

Regarding sustainability, at one level it is a question of commitment, perceived need and, of course, cost. It is also a question of whether these therapeutic products are foods or medicines! The question of sustainability only really arises because they are perceived as foods and there is food available locally. If we think of them as medicines, then it is different. None of the medicines used in modern medicine are 'sustainable' in most developing countries. If we do not question the sustainability of measles vaccine, vitamin A capsules, folic acid tablets and antibiotics, why, we should ask, do we question the sustainability of F75 supply?

By sustainability we ask, in effect, questions like "do we need it", "must we have it", "must we import it", "can we afford it", "who will pay for it", "what will be the effect of not having the product", "can we do it more cheaply or efficiently", etc. The answers to these questions are becoming clearer.

1. The protocols work! In Ethiopia, for example, 20,000 children are being treated each month (nearly a quarter of a million per year) with a mortality rate of around 3.5%. This is a very major advance on what was happening only a few years ago when the mortality rates were around 20-40%. Special products such as therapeutic milks (especially F75) and Ready to Use Therapeutic Foods (RUTF) have revolutionised the management of severe malnutrition (but see below about causes of mortality). So let us say that some sort of product is needed.
2. Treatment of the severely malnourished is a cost effective way of saving life, even compared to other public health interventions. The cost of saving a life with measles vaccination campaign or vitamin A capsule distribution is of the same order or more than the treatment of a severely malnourished child with therapeutic products. This is because the other interventions are aimed broadly and many are given the intervention in order to treat one life-threatening event, whereas with treatment of severe malnutrition the intervention is focused (targeted) at the very vulnerable who have a high risk of death without intervention. Also, compared to HIV treatment, therapeutic feeding bears a relatively trivial cost! Why should the biggest killer of children - malnutrition - be 'saddled' with sustainability arguments when the HIV/AIDS antiretroviral treatment (completely unsustainable) is being rolled out over the whole of Africa?
3. More than half of all deaths have malnutrition as the underlying cause (they would not have died if they were not malnourished). Can we afford not to treat such a condition? The challenge is to extend the treatment to all that need it, and here cost really does become a factor. Particularly when we start to extend treatment to the moderately malnourished (as a programme, this is much more expensive and less sustainable) and then to the convalescent - as is happening in Niger at the moment.
4. UNICEF has made the commitment to support these therapeutic programmes with therapeutic products. This, of course, needs a major commitment on their part and I have no doubt that the commitment is real and the intention is to sustain support for this type of activity.
5. There is no reason why therapeutic products, such as F75, Resomal and F100, could not be produced locally with quality control, etc., in many countries - similar to the local RUTF manufacture.
6. We now have a 'gold standard' in F75 and F100 that not only produce good rates of weight gain, but also return the children to physiological normality. The treatment of the very ill malnourished patient during the first few days of treatment will probably remain with commercially produced F75 for the foreseeable future. Relatively small amounts are needed for this (about one kilo per patient) as most patients can be started directly in phase 2 (up to 80% of those that are anthropometrically severely malnourished). With such small amounts, it is far more efficient to purchase the commercial product.

Having a gold standard formula for F100/ RUTF, on the other hand, now allows us to start to develop other foods and recipes - from local ingredients - that have the same nutritional and therapeutic properties and will allow the widespread sustainable treatment of far large numbers of children than can be treated at the moment.

I would suggest that we should START with commercial products. Where these are not available or where there is a rupture in the supply pipeline, we have alternative recipes that can be used - with the caveat that they will need extra staff, support, supervision, quality control, training etc, when they are used - and the staff will have to be of a much higher calibre. In the meantime, there has to be a research effort to emulate the results with various blends of local foods. But we should not compromise on quality of care and accept an inferior treatment just to make a programme, which is already cost effective in relative terms, cheaper (at the cost of lives).

Final few words

It is critical to remember that these commercially based therapeutic diets are not magic bullets that can be simply given without strict training on, and adherence to, the full protocol for managing severe malnutrition. In one of our analyses, we found a lower mortality with the old home-prepared highenergy- milk than with F75/F100. At first this was puzzling. But it became clear that the metabolic changes that occur with the modern diets are very rapid and can result in dysequlibrium syndromes, so that the children are even more vulnerable to therapeutic mistakes, certainly in terms of electrolytes.

I think we should emphasise that these are THERAPEUTIC products (i.e. they are medicines), that they are quite different from milks or infant formula, which are not available to the general public and are not advertised per se. Although a lot of people do know about them, these are mainly technical people so the production is DEMAND driven rather than advertisement driven, and the products are not replacing any natural process (such a breastfeeding).

We are in the middle of a nutritional revolution - let us be at the forefront of thinking and advocacy and not shoot ourselves in the foot by negative sustainability considerations - if it is needed, it is needed. We need advocacy for funds, implementation and research and we need to all be pulling in the same direction for the sake of the children.

Cheers
Prof Mike Golden

Note from a colleague

Dear Rebecca,

I read with interest Mike's perspective/experiences on the issue of use of the therapeutic milks and RUTF in treatment of severely malnourished children. The issues he describes are those we've experienced in the field. We make a big point of describing the therapeutic milks as 'medicine', not food, and insist that they be used as such.

What I have a real problem with is the increasing adoption of RUTF as a substitute 'food' to treat children whose diets are poor (and thus probably a major contributing factor to undernutrition). Isn't the 'right to food' that is familiar and nutritionally and culturally acceptable (i.e. real food, not formulations that carry macro- and micro-nutrients) a basic human right? It seems to me that the move in the direction of making formulations like Plumpy'nut widely available to 'all children who need it' puts energy into a strategy that perhaps provides an easier 'technical' solution, but one that must ultimately be less satisfactory to populations who should be able (like others) to raise their children on real, nutritionally adequate, food. The solution sidesteps the real problem, in my view.

Regards,
Mary Lung'aho
CARE USA

Responses from Prof Ann Ashworth Hill and Prof David Sanders home in on the issue of sustainability.

Dear Rebecca,

Nutriset F75 and F100 are certainly easier to use than 'homemade' (as you just tip out the packet and add 2 litres of water). It reconstitutes well, so there is no worrying about oil separating out. Also, all the electrolytes and micronutrients are included, so there is no worry about organising supplies of electrolyte/ mineral mix or CMV.

BUT sustainability is a big issue. Take Tanzania for example. They were making 'home-made' versions with fresh cows milk and adding sugar, oil and CMV. After the WHO/UNICEF training in Sept 2006, the MoH/Paediatric Association of Tanzania arranged for the UNICEF country office to supply Nutriset F75 and F100. In April we found a lot of wastage as the nurses would make up 2 litres, even though they only needed 500ml, for example. (This can be avoided by weighing out/measuring appropriate amounts for 500ml, 1000ml, etc.). But there is no continuity of supply and they have run out. So they reverted to the homemade system, only to find that they have to start organising CMV or electrolyte mineral mix once again, and the system creaks and groans and they lose momentum (and even the skill of making the home-made version). Continuity of supply could well be improved by earlier, timelier reordering by the pharmacy - they did leave it rather late to reorder.

Take Queen Elizabeth Hospital, Blantyre (Malawi) as another example. They used to make their own therapeutic milk. Then when they had 'emergency' status, they switched from homemade to Nutriset F75 and F100, as it came free and was easier. But when the emergency status ended, the MoH was in a quandary. They could not afford to buy F100. When I was there, the MoH was thinking of buying Nutriset F75 in the relatively small quantities that it is used, but they were stuck about what to do regarding the F100.

TdH provides DSM and CMV. If the hospital has good dietary scales and a blender, then it is easy to reconstitute. It will cost less than Nutriset milks but will be very similar in composition. The Nutriset milks have lower osmolarity as they use dextrimaltose instead of sugar, but otherwise they will be virtually the same.

I would support TdH's current practice. If it works, then there is no point of changing to a system that would be more expensive and might be precarious.

Best regards
Ann

Dear Rebecca,
My feeling is one of great caution. I think that it is much more sustainable to rely on available products such as dried skim milk than on imported expensive items. I do not think that Nutriset products will be sustainable. If you are interested in an analogy, read 'Questioning the Solution,' a book David Werner and I wrote about Oral Rehdration Salts (ORS) sachets for diarrhoea - also not sustainable. There is evidence that those countries that have promoted safe rehydration fluids made up from locally available items e.g. sugar and salt or cereal-based fluids, are better able to sustain widespread and life-saving management of dehydration, because of interruptions in supply of sachets as a result often of unaffordability or delivery problems.

In my opinion it is, unfortunately, false to extrapolate from the emergency situation to the 'normal' country situation. Availability of commodities, precise conduct of procedures, and indeed outcomes in severe malnutrition are generally very good in emergency situations where special infrastructure and, more importantly, good staff ratios and committed (often expatriate) staff are present. Ironically, for populations living in 'non-emergency' situations in many African countries, the situation is often not nearly so good. There are shortages of equipment, drugs and staff, who are often inadequately trained, poorly paid and supported and, understandably, demoralised. This situation will only be corrected by major reforms (including economic policies) that ensure sustained improvements in funding, increases in staff numbers and competence, and improved support and supervision. Until such time, my view is that it is more responsible to base interventions on what is safe, effective AND more likely to be obtainable in the country. For, sadly, the comparison will often not be between made-up F75 and Nutriset, but in reality between made-up F75 and nothing.

Best regards,
David Sanders