RUTF and its absence

Today was an eventful day for treatment....and lack thereof

Today MSF announced the quality assurance certification of Compact's Ready to Use Therapeutic Food (RUTF) in India. This means that after months of quality and safety tests and inspections Compact's eeZeePaste can be safely used for the treatment of uncomplicated severe acute malnutrition (together with UNICEF, MSF is the recognized world authority on RUTF QA Certification). No word yet from the government on whether or not this life saving treatment for severe acute malnutrition will be allowed for use domestically.

I also visited the Nutrition Rehabilitation Center in Jhabua where they are treating 35 children with severe acute malnutrition (SAM) - 15 patients over their capacity of 20 beds. Patients are flowing into the pediatric ward of the hospital which is also over capacity with plenty more children hospitalized for severe diarrhea and cases of typhoid with 2-3 children per bed. Neighboring Thandla's NRC is also over capacity with 25 patients in their 10 beds.




As I sat down to catch up with Heena, the amazing nutritionist at the NRC who works above and beyond the call of duty, a batch of 5 children came into the NRC from just one block. She had been told the previous week not to accept more children than the NRC's capacity, but put her foot down saying that she would not send a child with complicated malnutrition home to die in the village. And she hasn't. As I shadowed her and the attending pediatrician through the process of screening and admitting these children, one child, a one year old with a shriveled up face and the leathery, wrinkly, hands of an old person started having trouble breathing. As the doctors rushed this child into the critical care unit with oxygen and started to insert a nasal gastric tube, I had to look away and sat with the other patients. Four children sat in worried mothers' arms, their dull-eyes almost waiting to be next. It's heartbreaking to see a child without that spark in their eye. As a one or two year old, what is exciting about the world if you don't even have the energy to lift your head?

The children I saw today desperately needed inpatient care for their severe severe severe acute and complicated malnutrition. But they didn't have to get to this point. They could have, should have had access to clean, safe, medically sound treatment for their severe acute malnutrition before they developed complications and began to slip. Also there should have been an intervention with these children when they had moderate acute malnutrition so that they wouldn't have become severe and needing treatment. Families should have been counseled and should have had access to prevention services so that these children wouldn't have become malnourished in the first place.

But the biggest tragedy today is the fact that these children desperetely required treatment at the village level to prevent the state they presented with at the NRC. And that treatment is available. But because of politics, field level workers are not allowed to use this treatment.

I'm opening up a can of worms for arguing on behalf of RUTF, but this is life or death. Politicians do not stare into the dull eyes of a malnourished child.

There has been a lot of debate about RUTF in this country since the Department of Women and Child Development (not the Department of Health) asked UNICEF to stop using RUTF in their emergency treatment efforts for severely malnourished children in the flood zones of Bihar and in Kalwa Block of Khandwa, MP (where over 60 children died of malnutrition in just 3 months). UNICEF was severely reprimanded for using an RUTF imported from France without explicit national government permission. For more press coverage of this debate, see the following articles:
http://in.reuters.com/article/domesticNews/idINDEL49936320090804?pageNumber=1&virtualBrandChannel=0
http://www.timesonline.co.uk/tol/news/world/asia/article6739362.ece

Opponents of RUTF cite the high cost of RUTF and question its sustainability. They fear that RUTF will be used as a supplement and will slowly begin to replace breast milk and rice and dal in the family pot. They do not understand that RUTF is a medical treatment advised for 14 days and cannot be replaced with local concoctions. Opponents of RUTF do not understand RUTF.

Let me clear up some facts about RUTF.

As I've described before, there are currently an estimated 8 million children under five years of age across India with severe acute malnutrition (SAM) a condition defined by extremely low weight-for-height or mid-upper arm circumference and carrying the risk of death for 10-20% of those afflicted. All these children require urgent treatment to bring them back to normal growth, but not all of them require hospitalization. Approximately 80% of these children, or 6.4 million, will have uncomplicated SAM, which means that while they are dangerously malnourished, they do not present with any complications such as pneumonia, hypothermia, edema, diarrhea etc. These uncomplicated cases require urgent care not necessarily in a facility but can receive RUTF administered in a community-based therapeutic care model. There will never be enough facilities in MP to treat the 1.3 million children who require SAM treatment right now.

There is currently no treatment option available for out-patient care for severe acute malnutrition in India. While there are many local recipes available for community based treatment of moderate acute malnutrition, these “home remedies” cannot be used for severe acute malnutrition because of the SAM child’s delicate state. A child with SAM needs specialized treatment that properly balances carbohydrates, lipids, proteins, and micronutrients in an energy-dense formula. Because of their fragile state of malnutrition, potential contaminants in this treatment, whether from unclean water or any other toxins that can be found in many village kitchens, may put the life of a child at risk. RUTF provides the right dose of nutrients to help a child with SAM recover quickly, without chance of contamination

RUTF is a medicine, not a supplement: RUTF is a formulation that should be treated like a medicine. It’s the equivalent to the F-100 formula (milk-based) used at hospitals across India but is instead made in a paste that can be safely given to a child to take home. RUTF is not a supplementary food or a method to prevent malnutrition, but is a treatment for a fixed amount of time to get a child back on a normal growth pattern and prevent death. RUTF has had astounding success in malnutrition treatment programs around the world.

The advantages of RUTF are:

a) if the child passes an appetite test, uncomplicated cases of acute malnutrition can be managed without going to the hospital
b) no risk of contamination since the product does not require water
c) no special training is needed to use RUTF
d) highly cost-effective compared to in-patient based approaches
e) weight gain from RUTF is higher than weight gain from F100 (5 times) and from fortified flours and other fortified foods used in supplementary feeding programs because the energy-density of RUTF is higher than in other formulations.

RUTF gives the mothers/families, assisted by trained local health workers, the primary role in treating malnutrition in their children. In this way, thousands of malnourished children can be managed in the community without caregivers having to spend days in hospitals and away from their families and work. It takes much of the burden off of government nutrition rehabilitation centers, allowing doctors to focus on only the most serious, complicated cases of SAM.

RUTF should be administered weekly under the supervision of trained health workers in conjunction with the child’s family over a 6-8 week period.

RUTF will be administered until the child has gained adequate weight. The child will then transition to a nutritious diet prepared by their family using locally available products along with micronutrient supplements.

RUTF is equal to F100/F75 not to local supplements: The WHO recommendations state that F100/F75 should ideally be used for inpatient treatment of complicated SAM cases. While the Government of India, with the recommendation of the Indian Academy of Pediatrics, recommends the use of F100/F75 - the same recipe, with equivalent nutrient content and higher caloric density used as a take-home formulation has raised an incredible controversy, despite being more effective in terms of weight gain, less expensive overall, and able to reach more children.

This is not to say that local products and remedies can't be effective in treating SAM. These should be considered as alternatives when RUTF isn't available and are up to the choice and tradition of every family. But on a whole, they're not working because we still see astronomical SAM rates.

As a policy, the government should look at what is the most effective treatment for SAM and should rely on domestic and international medical research. The recipes used by many groups in the field to treat SAM have not been clinically tested or even evaluated for their nutrition content. A critical element for the care of a SAM child is knowing their caloric and micronutrient intake. These local recipes should undergo clinical trials and evaluations if they are to be used as medical therapy.

SAM treatment is different than Moderate Acute Malnutrition (MAM) treatment: Children with SAM are at a high risk of dying and require a specifically therapeutic formulation for optimum weight gain, children with MAM do not. Local production of the foods recommended by DWCD would be perfectly targeted for MAM treatment. Treating the larger MAM population with local foods serves as a preventative measure and could also employ self help groups, community groups, use local produce and stimulate the local markets. These two feeding methods should be complementary, not exclusive. Local supplements are also ideal for ensuring that a child who has recovered from SAM does not slip back into malnutrition.

RUTF requires a high standard of quality control that villages cannot guarentee: RUTF should be produced in a facility that has been certified as meeting international food quality standards (Codex & HAACP regulations). RUTF production is tricky. Micronutrients and other ingredients need to be weighed precisely. There are many potential contaminantes from the aflatoxins in the peanuts to bacteria in milk power and oil that could make the product more harmful rather than beneficial. With their weak immune systems, even a small contamination could kill a SAM child. A village level nutrition supplement for SAM cannot effectively provide the high standard of quality assurance that is required for SAM supplements. RUTF production sites need sophisticated laboratory equipment on site and dedicated food scientists to check for toxin levels, bacteria, and other contaminents daily, in addition to food quality testing such as making sure that nutrition levels are as specified, that moisture is not present in the product and a whole number of other checks. These in-house labs also should undergo regular external quality assurance tests.

International success: RUTF has done wonders in reducing the malnutrition load and in responding to nutritional crisises across Africa and Latin America, especially in Malawi and Ethiopia. There are many studies that have compared RUTF's effectiveness vis a vi local alternatives and F100,F75: Each time RUTF comes out on top. Ethiopia, Malawi, Niger, South Africa, Cambodia, Mozambique, Haiti, Dominican Republic, and shortly, Nepal, all have or will have national level production of RUTF. MSF, UNICEF, WFP, Clinton Foundation, WHO - and the list goes on - all recommend using RUTF to treat SAM. I've included references to a few key international studies on RUTF below.

The way forward - RUTF domestic production: Before Compact started to make RUTF in India, the best of the few options for RUTF procurement in India was the industry leader Nutriset, who makes the original RUTF called Plumpy-nut. While this product is the international gold standard, it is expensive and has to be imported. For India to employ a long-term community based therapeutic care strategy for treatment of severe acute malnutrition, local, non-commercialized production of RUTF is ideal. This will take some time to institute, however. In the meantime there are two manufacturers, Cipla and Compact, who are making RUTF in India (Mumbai and Manesar, respectively). These low cost, high quality products can help us treat the millions of children who have SAM and would be ideal to procure for the national program until local production can be scaled up.

And as I started this posting off, Compact just got their quality certification. I've been to the plant, I've tasted their RUTF, I've met with their CEO, a man with morals who is out to save children's lives and not make a profit. This is the best option we've got. RUTF will allow millions of more children to be treated for SAM at the village level, freeing up NRC space so that Heena and her team can concentrate on just the most severe cases.

RUTF is only a temporary measure and a small part of the long fight against malnutrition. However is it a cost effective and safe means of treating acute malnutrition in children in a public health setting. RUTF is treatment which, if accompanied with proper community-based counseling and support mechanisms, should only be administered to a child once for up to one month. The goal is that by promoting local production of food supplements to treat MAM and through grassroots effort to prevent malnutrition, that RUTF will be used less and less over time.

For further reading, check out:

WHO/WFP/UNICEF Consensus document on "Community Based Treatment of Severe Acute Malnutrition" 2007: http://www.who.int/nutrition/topics/statement_commbased_malnutrition/en/index.html

Compact's product: http://www.compactforlife.com/eezeepaste-rutf/

and a whole list of studies to back this up:

• Ciliberto, Michael A., et al., ‘Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: A controlled,
  clinical effectiveness trial’, The American Journal of Clinical Nutrition, vol. 81, no. 4, 2005, pp. 864–870.
• Collins, Steve, ‘Changing the way we address severe malnutrition during famine’, The Lancet, vol. 358, 11 August 2001, pp. 498–501.
• Collins, Steve, and Kate Sadler, ‘Outpatient care for severely malnourished children in emergency relief programmes: A retrospective cohort study’, The Lancet, vol. 360, 7 December
  2002, pp. 1824–1830.
• Collins, Steve, et al., ‘Management of severe acute malnutrition in children’, The Lancet, vol. 368, no. 9551, 2 December 2006, pp. 1992–2000.
• Diop, El Hadji Issakha, et al., ‘Comparison of the efficacy of a solid ready-to-use food and a liquid, milk-based diet for the rehabilitation of severely malnourished children: A randomized
  trial’, The American Journal of Clinical Nutrition, vol. 78, no. 2, August 2003, pp. 302–307.
• Gross, Rainer, and Patrick Webb, ‘Wasting time for wasted children: Severe child undernutrition must be resolved in nonemergency settings’, The Lancet, vol. 367, no. 9517, 8 April 2006, pp. 1209–1211.
• Manary, Mark J., et al., ‘Home based therapy for severe malnutrition with ready-to-use food’, Archives of Disease in Childhood, vol. 89, June 2004, pp. 557–561.
• Navarro-Colorado, Carlos, and Stéphanie Laquière, ‘Clinical trial of BP100 vs F100 milk for rehabilitation of severe malnutrition’, Field Exchange, vol. 24, March 2005, pp. 22–24,
• Prudhon, Claudine, et al., 'WHO, UNICEF, and SCN Informal Consultation on Community-Based Management of Severe Malnutrition in Children', SCN Nutrition Policy Paper No. 21, Food and Nutrition Bulletin, vol. 27, no. 3 (supplement), 2006,
• Sandige, H., et al., ‘Home-based treatment of malnourished Malawian children with locally produced or imported ready-touse food’, Journal of Paediatric Gastroenterology and Nutrition, vol. 39, no. 2, August 2004, pp. 141–146.
• World Health Organization and UNICEF, Global Strategy for Infant and Young Child Feeding, WHO, Geneva, 2003
• http://www.ahrchk.net/statements/mainfile.php/2009statements/2083/
• and theres many more where that came from
• Thank you to Rebecca and Fabian for helping me understand RUTF and providing countless references