We thank Cooney and Partridge for their interest in our article.1 We believe, however, that they have misunderstood much of what we wrote. We accessed websites with publicly available national and subnational data on population-level rates of religious affiliation and breastfeeding initiation. As we explained, two other selection criteria reduced the number of countries we examined: (1) sufficient within-population variability in both religious affiliation and breastfeeding initiation and (2) data on both variables, so that they could be associated at the same ecological (geographical) level. As we acknowledged, we did not find Lander-level data for Germany, the country that best met our selection criteria. Our inclusion of data from French-speaking regions is clearly a strength of our study--not a limitation. We used Protestant affiliation as defined in the databases we found, and we focused on the major Protestant groups in the general population. Since the data we used are publicly available, we invite Cooney and Partridge to analyse the associations between minor Protestant groups and breastfeeding rates in Ireland. Regarding the definition of Protestants, any degree of misclassification should have reduced, rather than increased, the associations we observed. Our scatterplots show the crude (unadjusted) data together with the crude correlations. For France, Ireland, the UK and Canada, crude and adjusted results were all in the same direction: a negative correlation be...
We thank Cooney and Partridge for their interest in our article.1 We believe, however, that they have misunderstood much of what we wrote. We accessed websites with publicly available national and subnational data on population-level rates of religious affiliation and breastfeeding initiation. As we explained, two other selection criteria reduced the number of countries we examined: (1) sufficient within-population variability in both religious affiliation and breastfeeding initiation and (2) data on both variables, so that they could be associated at the same ecological (geographical) level. As we acknowledged, we did not find Lander-level data for Germany, the country that best met our selection criteria. Our inclusion of data from French-speaking regions is clearly a strength of our study--not a limitation. We used Protestant affiliation as defined in the databases we found, and we focused on the major Protestant groups in the general population. Since the data we used are publicly available, we invite Cooney and Partridge to analyse the associations between minor Protestant groups and breastfeeding rates in Ireland. Regarding the definition of Protestants, any degree of misclassification should have reduced, rather than increased, the associations we observed. Our scatterplots show the crude (unadjusted) data together with the crude correlations. For France, Ireland, the UK and Canada, crude and adjusted results were all in the same direction: a negative correlation between rates of Catholic affiliation and breastfeeding initiation. For the U.S., however, the crude correlations were in the opposite direction, because they were confounded by race/ethnicity and education. Displaying the crude data for U.S. states would therefore mislead the reader from the “true” (unconfounded) result: again, a negative correlation between the rates of Catholics affiliation and breastfeeding initiation among non-Hispanic Whites. We do not deny that other factors affect breastfeeding initiation rates in Western countries and could confound the association we observed with religious affiliation. They might also modify the effect of religious affiliation on breastfeeding. Race/ethnicity is one such factor, which is why we stratified our analysis of U.S. states by race/ethnicity. 1. Bernard JY, Cohen E, Kramer MS. Breastfeeding initiation rate across Western countries: does religion matter? An ecological study. BMJ Glob Health 2016;1(4):e000151. doi:10.1136/bmjgh-2016-000151.
Drs. Dadhich and Prasad raise important issues in their comments and questions about our study on home-based management of children with uncomplicated severe acute malnutrition (SAM). We are grateful for the opportunity to respond to them.
In our view, there are two distinct goals in the management of children with SAM. The first, and more urgent, is to treat and move them away from severe malnutrition, a state of high risk of death. The second is to rehabilitate them to the point they are no longer malnourished. The treatments examined in the study achieved the first goal well. By the end of the treatment phase, 84.5% of the children in the RUTF-L group were no longer SAM. However, they did less well in achieving the second goal. By the end of the treatment phase, 57% of those receiving RUTF-L had recovered to the point of no longer being malnourished. Should we have applied the same approach as most studies to calculate their WHZ - using height at enrolment and current weight, rather than concurrently measured height and weight - 81% of the children in the RUTF-L group would no longer be classified as malnourished by the end of the treatment phase.
We note Dr. Prasad’s misunderstanding that over 40% of the children in our study remained SAM by the end of the treatment with RUTF-L. Should her interpretation have been correct, it would justify her expressed concern. However, as stated above, by the end of the treatment phase 84.5% of the c...
Drs. Dadhich and Prasad raise important issues in their comments and questions about our study on home-based management of children with uncomplicated severe acute malnutrition (SAM). We are grateful for the opportunity to respond to them.
In our view, there are two distinct goals in the management of children with SAM. The first, and more urgent, is to treat and move them away from severe malnutrition, a state of high risk of death. The second is to rehabilitate them to the point they are no longer malnourished. The treatments examined in the study achieved the first goal well. By the end of the treatment phase, 84.5% of the children in the RUTF-L group were no longer SAM. However, they did less well in achieving the second goal. By the end of the treatment phase, 57% of those receiving RUTF-L had recovered to the point of no longer being malnourished. Should we have applied the same approach as most studies to calculate their WHZ - using height at enrolment and current weight, rather than concurrently measured height and weight - 81% of the children in the RUTF-L group would no longer be classified as malnourished by the end of the treatment phase.
We note Dr. Prasad’s misunderstanding that over 40% of the children in our study remained SAM by the end of the treatment with RUTF-L. Should her interpretation have been correct, it would justify her expressed concern. However, as stated above, by the end of the treatment phase 84.5% of the children in the RUTF-L group were no longer SAM.
We also note the concern that the ease and extent of recovery in our study is less than reported in African trials. However, as indicated in the paper, the population in our trial was significantly different from that in African trials: only 0.2% of our children had oedema, while it ranged from 38-80% in African trials. The mean WHZ score in our trial population was -3.5 while the mean ranged from -2.0 to -2.8 in Africa. Such differences make comparisons on ease and speed of recovery quite hazardous. One informed expectation is that recovery in the Indian population would take longer as they were further from the target of WHZ ≥ -2 SD.
We acknowledge Dr. Dadhich’s interest in the comparison of the performance of RUTF-C and RUTF-L. However, the trial was not designed to compare them. Given the lack of power for this comparison, we refrained from examining possible differences in their efficacy. We know that the composition of the two products was essentially the same and believe that any potential differences would likely be due to users’ preferences.
We agree that additional ways need to be found to rehabilitate these children. We see that in responding to SAM needs actions at the hospital level for children with complicated SAM, and at the community level, for treatment of uncomplicated cases, rehabilitation and prevention. Success requires that we provide treatment and also support families through comprehensive child care and promoting the best use of local resources. The rehabilitation of malnourished children, the sustainability of improvements and prevention of SAM need greater attention and possibly new approaches. We may need to extend the period of treatment while scaling down the management with therapeutic foods, or we may be more successful by increasing efforts to improve complementary feeding while continuing to use therapeutic foods as a supplement, or we may focus our efforts on improving complementary feeding without recourse to supplements. These approaches – or other that may be identified – should be tested to guide future efforts.
In the end, rehabilitation by whatever means must be a part of a comprehensive program and reach all target infants and children. This will require engagement at home, community and facility and not only facility-based interaction. It may be that some redesign of our overall strategy is needed. The issue of nutrition and growth in early life is critical and needs an evidence-based, thoughtful and yet practical way forward.
Medicines supplied in low and middle income countries are a matter of concern especially in regard to their quality. This article has raised a very genuine issue regarding the quality of medicine supplied to low and middle income countries(Nebot Giralt et al. 2017). This comment has been written in context to Nepal, a low income country as per the World Bank classification with population of around 28 million, out of which around 25 % of the people are living below the poverty line and 80% of the people living in rural areas(Central Bureau of Statistics 2015). The current ongoing Mass Drug Administration (MDA) for Elephantiasis in Nepal as a target to eliminate filariasis by 2020 has not been able to achieve its target due to poor compliance to the medicine. One of the reason could be due to people questioning about the quality of medicine distributed by government which could be the result of news spread five years back which stated five deaths, which later on was declared MDA not being the cause of death and more than 800 people falling ill after taking the medications. But still the fact cannot be ignored without proper investigation(Pandey 2012).
Still, many regions of the country lack access to basic health facility and essential medicine. The government of Nepal as per the national health policy has listed around 70 different drugs like anti-viral, anti-protozoal, some drugs for non-communicable diseases and so on to be distributed free of cost. The few p...
Medicines supplied in low and middle income countries are a matter of concern especially in regard to their quality. This article has raised a very genuine issue regarding the quality of medicine supplied to low and middle income countries(Nebot Giralt et al. 2017). This comment has been written in context to Nepal, a low income country as per the World Bank classification with population of around 28 million, out of which around 25 % of the people are living below the poverty line and 80% of the people living in rural areas(Central Bureau of Statistics 2015). The current ongoing Mass Drug Administration (MDA) for Elephantiasis in Nepal as a target to eliminate filariasis by 2020 has not been able to achieve its target due to poor compliance to the medicine. One of the reason could be due to people questioning about the quality of medicine distributed by government which could be the result of news spread five years back which stated five deaths, which later on was declared MDA not being the cause of death and more than 800 people falling ill after taking the medications. But still the fact cannot be ignored without proper investigation(Pandey 2012).
Still, many regions of the country lack access to basic health facility and essential medicine. The government of Nepal as per the national health policy has listed around 70 different drugs like anti-viral, anti-protozoal, some drugs for non-communicable diseases and so on to be distributed free of cost. The few published studies have suggested inadequate quality of drugs, bureaucratic process of drugs approval as barrier to the implementation of free drugs service which should not be ignored(Singh et al. 2017). Furthermore a cross sectional study done in Kathmandu, Nepal to assess the quality of drugs present in Nepalese market concluded that substandard medicine are available in Nepalese market and weak regulation and no uniformity in similar pharmaceuticals products(Gyanwali et al. 2015).
Although there are production of some essential medicines in Nepal more than half of the drugs required are imported from other countries and majority of them are distributed through different government and non-government organizations and international humanitarian aids. According to National List of Essential Medicines 2011, Of the 537 products in various strengths and dosages, Nepali companies were producing less than one third, 176 products(Brhlikova et al. 2015). Nepali health programs funded by international aid largely bypass government regulators and local producers as international agencies procure through large companies with an international GMP certificate. The Nepali local pharmaceutical industry has been growing significantly over the last decade. Many local producers are not affected by international quality standards as they do not export medicines and the Department of drug administration (DDA) does not enforce the WHO GMP standards strictly.
Further research exploring the quality of medicines in the Nepalese context seems as the need of the hour.
Brhlikova, P. et al., 2015. Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal. Globalization and health, 11(1), p.25. Available at: http://www.scopus.com/inward/record.url?eid=2-s2.0-84935862368&partnerID=tZOtx3y1.
Central Bureau of Statistics, 2015. Nepal in Figures,
Gyanwali, P. et al., 2015. Surveillance of Quality of Medicines Available in the Nepalese Market: A Study from Kathmandu Valley. Journal of Nepal Health Research Council, 13(31), pp.233–240.
Nebot Giralt, A. et al., 2017. Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes? BMJ Global Health, 2(2), pp.1–7. Available at: http://gh.bmj.com/content/2/2/e000172.
Pandey, J., 2012. Elephantiasis : Banke folk worried about campaign. The Kathmandu Post. Available at: http://kathmandupost.ekantipur.com/printedition/news/2012-01-07/elephantiasis-banke-folk-worried-about-campaign.html.
Singh, D. et al., 2017. Designing the Free Drugs List in Nepal. MDM Policy & Practice, 2(1), p.238146831769176. Available at: http://journals.sagepub.com/doi/10.1177/2381468317691766.
We are concerned that the recent paper by Bernard et al published in BMJ Global Health 2016 fails to provide a scientific basis to support the stated conclusion that within Western countries the proportion of Catholics in the population influences the breastfeeding initiation rates.
The paper does not include a literature review on the role of religion in relation to infant feeding and there is no convincing scientific rationale presented to support the hypothesis being tested. There then follows a description of the study’s methods and results which reveals a series of methodological and reporting problems which, in our view, renders the work wide open to biases, confounders and incorrect deductions.There is evidence of selection bias in the five countries selected for within-country analyses, all limited to specific Western countries, with no explanation as why these particular countries were selected for inclusion. It is noteworthy that of these selected five, the dominant languages for each is either English or French which suggests language bias may also be a factor.
A further problem with the methods is the unexplained differences in the selection of the Protestant populations for each of the five countries. For the US the researchers included two categories of Protestants in their analysis (Evangelical Protestants and Mainline Protestants), for Canada and France the category of Protestants was used but then for the U...
We are concerned that the recent paper by Bernard et al published in BMJ Global Health 2016 fails to provide a scientific basis to support the stated conclusion that within Western countries the proportion of Catholics in the population influences the breastfeeding initiation rates.
The paper does not include a literature review on the role of religion in relation to infant feeding and there is no convincing scientific rationale presented to support the hypothesis being tested. There then follows a description of the study’s methods and results which reveals a series of methodological and reporting problems which, in our view, renders the work wide open to biases, confounders and incorrect deductions.There is evidence of selection bias in the five countries selected for within-country analyses, all limited to specific Western countries, with no explanation as why these particular countries were selected for inclusion. It is noteworthy that of these selected five, the dominant languages for each is either English or French which suggests language bias may also be a factor.
A further problem with the methods is the unexplained differences in the selection of the Protestant populations for each of the five countries. For the US the researchers included two categories of Protestants in their analysis (Evangelical Protestants and Mainline Protestants), for Canada and France the category of Protestants was used but then for the UK and Ireland they select only Protestants of Anglican religion – specifically, for the UK regions, the category Anglicans was used and then for Ireland Anglicans (Church of Ireland) is used. The rationale for confining the analysis to Anglican Protestants alone is not explained and the exclusion of data on the other Protestant religions such as Presbyterians, Methodists etc. strikes us as an important omission. For example, in Ireland the percentage of Anglicans is 2.9% (Ref 1). If other Protestant religions were included, this proportion would increase by a quarter to 3.6%. Similarly for the UK, the exclusion of non-Anglican Protestants in the four UK regions is also likely to have impacted on the results. Not being consistent and complete in the manner in which the Protestant groups were determined and enumerated undermines the scientific credibility of this work.
The presentation of results is of concern. The authors fail to clarify that each dot in Figure 2 represents findings from population groups that vary in size from the largest at a population of 53 million population for England to just under 32,000 for the smallest county In Ireland. Presenting results from such disparate population sizes can mislead reader’s interpretation of the scatter plot. Also, it is odd that the US data is presented separately from the other four countries included in the within-country analysis. Of note is the fact that the US was the outlier in that it differed from the others in having breast feeding rates that actually positively correlated with state-level proportions of Catholics. However, the authors subjected these data to a different analysis and presented the results separately. Of concern to us is that, unlike what had been done for the other four countries as displayed in Figure 2 and Table 3, the results by US state is not presented. Rather, the US data analysis included additional stratification by ethnicity (Non-Hispanic white, Hispanic white and Black) and presented separately in Table 4. As a result of this further analysis, the finding of the positive correlation with proportion of Catholics in US states is somewhat diluted.
There are a number of political factors and economic factors that impact on breastfeeding initiation rates and yet the authors have not included or considered these in this paper. It would have been particularly helpful if they had considered important potential confounders that may be associated with historical religious affiliations and infant feeding practices such as the economic importance of the dairy industry, including formula milk production, as well as demographic factors such as urban/rural population ratios.
Low levels of breastfeeding is a serious public health problem in many countries. In Ireland, we have one of the lowest breastfeeding rates in the world and, significantly, Ireland currently holds 10% of the global market share of infant formula production (Ref 2). Those of us working at improving breastfeeding rates seek to use the best evidence to inform the range of necessary interventions. We feel that it is therefore very important to highlight our concerns about the limited scope, flawed methods and difficulties in the presentation of the results of this study. In the interests of policy, practice and research, we argue that this paper fails to present convincing evidence to support the stated conclusion.
1.The Central Statistics Office Ireland, Census 2011, accessed 22nd Mar 2017 at: http://www.cso.ie/en/census/
2.Performance and Prospects 2014-2015 Bord Bia, Irish Food Board, accessed 22nd Mar 2017 at: http://www.bordbia.ie/industry/manufacturers/insight/publications/MarketReviews/Documents/Export-Performance-and-Prospects-2015.pdf
Pai et al put up a timely assessment of India’s ambition of achieving tuberculosis elimination by 2025.1 However, the authors seemed to have overlooked the major developments that have been introduced recently in the country. Inclusion of the updated facts could have enriched the discussion, I believe.
In January 2017, a door to door campaign for active case finding for tuberculosis has been started by the Central TB Division (CTD).2 The scheme, if proved successful, has the capacity to effectively reduce the mean delay of two months between appearance of symptoms and initiation of treatment. This, along with introduction of bedaquiline at six referral sites and enhancing the use of cartridge based nucleic acid amplification test across the country, is expected to boost the performance of Revised National TB Control Programme in near future. In fact, CTD has already decided to start daily regimen in 104 districts, spread over five states.3
Now, apart from the budget, the future would also depend on successful vigilance on the dispensing pattern of anti tubercular drugs from private and informal sectors. A study earlier has demonstrated the use of steroids and fluoroquinolones by the pharmacists for probable cases of tuberculosis.5 With the warning against the silent rise of drug resistant tuberculosis and a projected 275% increase in the risk of multi-drug resistant tuberculosis in India over next 20 years, the...
Pai et al put up a timely assessment of India’s ambition of achieving tuberculosis elimination by 2025.1 However, the authors seemed to have overlooked the major developments that have been introduced recently in the country. Inclusion of the updated facts could have enriched the discussion, I believe.
In January 2017, a door to door campaign for active case finding for tuberculosis has been started by the Central TB Division (CTD).2 The scheme, if proved successful, has the capacity to effectively reduce the mean delay of two months between appearance of symptoms and initiation of treatment. This, along with introduction of bedaquiline at six referral sites and enhancing the use of cartridge based nucleic acid amplification test across the country, is expected to boost the performance of Revised National TB Control Programme in near future. In fact, CTD has already decided to start daily regimen in 104 districts, spread over five states.3
Now, apart from the budget, the future would also depend on successful vigilance on the dispensing pattern of anti tubercular drugs from private and informal sectors. A study earlier has demonstrated the use of steroids and fluoroquinolones by the pharmacists for probable cases of tuberculosis.5 With the warning against the silent rise of drug resistant tuberculosis and a projected 275% increase in the risk of multi-drug resistant tuberculosis in India over next 20 years, the surveillance system for detecting cases and ensuring completion of treatment would have to play the major roles in coming days.6
References
1.Pai M, Bhaumik S, Bhuyan SS. India's plan to eliminate tuberculosis by 2025: converting rhetoric into reality. BMJ Global Health 2017;2:e000326. doi:10.1136/bmjgh-2017- 000326
2.Aditi Tandon. Soon, TB services on doorstep: Polio-like campaign to address TB burden from Jan 16. The Tribune, Jan 4, 2017. (Available from
http://www.tribuneindia.com/news/nation/soon-tb-services-on-doorstep/345735.html, last accessed on 22nd March, 2017)
3.Revised National Tuberculosis Control Programme. TB India 2016 annual status report. 2016. (Available from http://www.tbcindia.nic.in/index1.php?lang=1&level=2&sublinkid=4569&lid=3174, last accessed on 22nd March, 2017)
4.Anandhi CL, Nagaraj VK, Kumar R. Knowledge and practice pattern of non-allopathic indigenous medical practitioners regarding tuberculosis in a rural area of India. Indian J Tuberc 2002;6:553–55.
5.Satyanarayana S, Kwan A, Daniels B, et al. Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study. Lancet Infect Dis 2016;16:1261–68.
6.Law S, Piatek AS, Vincent C, Oxlade O, Menzies D. Emergence of drug resistance in patients with tuberculosis cared for by the Indian health-care system: a dynamic modelling study. Lancet Public Health 2017:2:e47-55.
This RUTF trial from India has compared the efficacy of RUTF (centrally produced and locally produced) with augmented energy-dense home-prepared foods (comparison group) for home based management of uncomplicated severe acute malnutrition (SAM).
I would like to draw attention of the authors on following issues.
1.The study reports that 40% children affected with SAM in the study did not recover even with a prolonged (16 weeks), supervised treatment with RUTF and other supportive measures like deworming, antibiotics at the initiation of treatment and increased access to healthcare for morbidity. The recovery rate was 17.3% with the use of locally produced RUTF and 12.1% with centrally produced RUTF at 16 weeks after the end of treatment phase. With such low recovery rates, is it prudent to make a recommendation for the policy that “Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalization”?
2.In this trial, researchers aimed to achieve an intake of 175 kcal/kg body weight/ day for the enrolled children and collected consumption data for both the RUTF groups which were largely comparable. But they fail to do so for the comparison group stating greater difficulty in capturing valid information. Authors need to explain if this has led to a less th...
This RUTF trial from India has compared the efficacy of RUTF (centrally produced and locally produced) with augmented energy-dense home-prepared foods (comparison group) for home based management of uncomplicated severe acute malnutrition (SAM).
I would like to draw attention of the authors on following issues.
1.The study reports that 40% children affected with SAM in the study did not recover even with a prolonged (16 weeks), supervised treatment with RUTF and other supportive measures like deworming, antibiotics at the initiation of treatment and increased access to healthcare for morbidity. The recovery rate was 17.3% with the use of locally produced RUTF and 12.1% with centrally produced RUTF at 16 weeks after the end of treatment phase. With such low recovery rates, is it prudent to make a recommendation for the policy that “Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalization”?
2.In this trial, researchers aimed to achieve an intake of 175 kcal/kg body weight/ day for the enrolled children and collected consumption data for both the RUTF groups which were largely comparable. But they fail to do so for the comparison group stating greater difficulty in capturing valid information. Authors need to explain if this has led to a less than robust comparison of outcomes between the two RUTF groups and the augmented energy-dense home-prepared foods group as energy intake in the comparison group is not known.
3.It will be useful if the authors provide opinion about efficacy of centrally produced RUTF in comparison to locally produced RUTF in treating SAM as adequate data in this regard are available to them in the study to do so. This information will be relevant from programmatic point of view as programmes for treatment of SAM in some states of India are using centrally produced RUTF.1
4.The study has reported that centrally produced RUTF was not efficacious in comparison to nutrient-rich homemade foods to treat SAM. It will be useful if authors can provide some underlying factors for this finding, just like they have explained many other findings in the discussion.
Reference:
1. National Health Mission – Government of Rajasthan. Poshan. Available at: http://nrhmrajasthan.nic.in/POSHAN.asp
Abdur Sarker et al have highlighted an incredibly important aspect of Bangladeshi society that acts as a pivotal part of achieving Universal Health Coveage (UHC). They have clearly highlighted aspects such as the promotion of health equity and access within cooperatives, however, two aspects of such societies have not been discussed, namely technology and education.
Reading Between the Lines of the RUTF trial, India
Nita Bhandari et al are to be congratulated for publishing the much-awaited findings of the trial conducted in India for home-based management of uncomplicated severe acute malnutrition; comparing the efficacy of ready-to-use-therapeutic-food (RUTF); centrally (RUTF-C) and locally produced (RUTF-L), with augmented home-foods (A-HPF). The rigorously conducted trial offers significant insights to this highly debated and discussed area of work i ii . However, its policy recommendations seem evasive and ill founded on the evidence.
It is hardly in question that children with SAM benefit from being fed calorie-dense and protein rich foods, including RUTF. What the authors note, however, is that the rate, ease and extent of achieving ‘cure’ is far lower than that seen in African studies. In fact, this is the first trial where the advisory committee – the Data Safety Monitoring Board has had to recommend a treatment period as long as 16 weeks. It also has had to recommend the introduction of paid workers that visited each household ‘several times’ through the day to personally supervise feeding, to be able to achieve even this impact across the arms. This corresponds to an understanding that malnutrition cannot be sufficiently countered in the field without supporting care-givers in practical ways. In fact, comparing ready-to-use foods with the raw material that was supplied...
Reading Between the Lines of the RUTF trial, India
Nita Bhandari et al are to be congratulated for publishing the much-awaited findings of the trial conducted in India for home-based management of uncomplicated severe acute malnutrition; comparing the efficacy of ready-to-use-therapeutic-food (RUTF); centrally (RUTF-C) and locally produced (RUTF-L), with augmented home-foods (A-HPF). The rigorously conducted trial offers significant insights to this highly debated and discussed area of work i ii . However, its policy recommendations seem evasive and ill founded on the evidence.
It is hardly in question that children with SAM benefit from being fed calorie-dense and protein rich foods, including RUTF. What the authors note, however, is that the rate, ease and extent of achieving ‘cure’ is far lower than that seen in African studies. In fact, this is the first trial where the advisory committee – the Data Safety Monitoring Board has had to recommend a treatment period as long as 16 weeks. It also has had to recommend the introduction of paid workers that visited each household ‘several times’ through the day to personally supervise feeding, to be able to achieve even this impact across the arms. This corresponds to an understanding that malnutrition cannot be sufficiently countered in the field without supporting care-givers in practical ways. In fact, comparing ready-to-use foods with the raw material that was supplied in the augmented home foods category, but had to be cooked, also underplays this issue and complicates the results, as does the fact that peer support was different in each arm (though statistically insignificant) and this was adjusted for in the results, without offering details on these differences and adjustments.
Nonetheless, results show that the differences between A- HPF and RUTF-C were not significant. RUTF-L (being different from RUTF-C only in texture) was found to be inexplicably better than A-HPF, achieving a 57% recovery rate compared to 43% in 16 weeks. However, 16 weeks after the intervention, the overall numbers of children cured had dwindled to 15%.
Thus, the data clearly shows that the overall impact across all three arms is low, with over 40% children remaining in SAM even after a prolonged period of intervention in the strongest arm. Even these gains are unacceptably temporary. In addition, the element of supervised feeding ‘several times a day’ by a paid peer counselor seems quintessential to the results across the arms. Far from encouraging the use of RUTF in India, all these facts seem to suggest that, given a certain equivalence of quality, the choice of product is largely irrelevant for the community management of malnutrition.
The question this paper should rather be discussing is, whether it is logical, practical, acceptable and cost- effective to have individualized paid workers offering supervised feeding of RUTF-L several times a day at sparsely scattered households, to be able to achieve only moderate and highly unsustained gains in treating SAM.
Instead, the existing alternative hypothesis for SAM prevention and managementiii ; supporting families through comprehensive childcare programmes that organize care, health and nutrition using local resources, needs to be taken seriously and tested if required.
Word count: 498
i Sachdeva HPS, Kapil U, Gupta A, Prasad V. “Sustainable developmental solutions or product- based illusions for addressing severe acute malnutrition?” Paper submitted to the World Nutrition Conference2016, held in Cape Town, South Africa from 30th August to 2nd September 2016. Available http://www2.tulane.edu/publichealth/internut/magic-bullets-workshop.cfm
ii Prasad V, Holla R, Gupta A. Should India use commercially produced ready to use therapeutic foods (RUTF) for severe acute malnutrition (SAM)? Social Medicine 2009; 4(1): 52-5.
iii Prasad V, Sinha D. Potentials, Experiences and Outcomes of a Comprehensive Community Based Programme to Address Malnutrition in Tribal India. International Journal of Child Health and Nutrition, 2015, 4, 151-162

‘The nationalist not only does not disapprove of atrocities committed by his own side, but he has a remarkable capacity for not even hearing about them’ (George Orwell, Notes on Nationalism 1945).
We read with concern Sen and colleagues’ discussion of potential breaches of ethical neutrality in the reporting of events in Syria by Non-Governmental Organisations (NGOs) and academic researchers. We fully concur that any research must be based on rigorous methodologies and robust ethical frameworks. However, when engaging in debates on ethics and critiques of existing research one should adopt a morally reflexive position and consider all the evidence that exists no matter who has produced it.
Over the past five years a large body of evidence from credible humanitarian and international organisations has been accumulated which clearly documents the use of chemical weapons, heavy weaponry, ballistic missiles, cluster and barrel munitions deployed by Syrian Arab Army (SAA) forces and its allies. It is unfortunate that in the Syrian context, no side has spared civilians or prioritised the protection and well-being of civilians. Human rights abuses have been carried out by all sides. However, abundant evidence exists that the SAA have been largely responsible for the mass of civilian casualties. A major study in the British Medical Journal of the causes of mortality in Syria attests to this. Since September 2015 the SAA has been assisted by the Russ...
‘The nationalist not only does not disapprove of atrocities committed by his own side, but he has a remarkable capacity for not even hearing about them’ (George Orwell, Notes on Nationalism 1945).
We read with concern Sen and colleagues’ discussion of potential breaches of ethical neutrality in the reporting of events in Syria by Non-Governmental Organisations (NGOs) and academic researchers. We fully concur that any research must be based on rigorous methodologies and robust ethical frameworks. However, when engaging in debates on ethics and critiques of existing research one should adopt a morally reflexive position and consider all the evidence that exists no matter who has produced it.
Over the past five years a large body of evidence from credible humanitarian and international organisations has been accumulated which clearly documents the use of chemical weapons, heavy weaponry, ballistic missiles, cluster and barrel munitions deployed by Syrian Arab Army (SAA) forces and its allies. It is unfortunate that in the Syrian context, no side has spared civilians or prioritised the protection and well-being of civilians. Human rights abuses have been carried out by all sides. However, abundant evidence exists that the SAA have been largely responsible for the mass of civilian casualties. A major study in the British Medical Journal of the causes of mortality in Syria attests to this. Since September 2015 the SAA has been assisted by the Russian army’s air force in addition to other allies leading to the accelerated destruction of physical infrastructure particularly healthcare facilities.
Despite their insistence that research on Syria is politically one-sided and relies heavily on social media reports, Sen et al do not appear to have properly scrutinised the many reports that document the targeting and destruction of health facilities by all sides. This research particularly that of Physicians for Human Rights has painstakingly made efforts to utilise multiple sources regardless of their political affiliations – government and opposition eyewitnesses in order to corroborate events on the ground. It is clear from this research that SAA forces and their allies are responsible for the bulk of civilian mortality and injuries. This mainly stems from the fact that the official opposition and other rebel groups do not possess air force capabilities which have inflicted the largest amount of damage.
In their previous work Sen et al have continually cited economic sanctions as being the primary cause of the detrimental health impacts on civilians in Syria and a driver of the refugee crisis. It is factually and statistically incorrect to claim that sanctions have had a greater health impact on the Syrian population than almost six years of direct military attacks on civilians, healthcare and systematic destruction of public infrastructure including water plants and sewage farms in opposition-held areas by three major armies (Syrian, Russian and Iranian).
We acknowledge the difficulties of collecting verifiable data in conflict zones and welcome further research on the health and social situation of those living in Government Controlled Areas. This is an issue which has been lacking in the coverage of the Syrian crisis and has often been filled by journalistic sources. However, obtaining reliable data and information from the Syrian government such as the Ministries of Health and Social Affairs in Damascus has proved almost impossible for researchers, multi-lateral and donor agencies. Indeed, accurate mortality statistics for SAA soldiers are impossible to access and yet could provide a more balanced understanding of losses on all sides.
Academics have a moral obligation to engage widely and with neutrality in information gathering, taking data provided by different sides of highly politicised debates into account. However, the facts-on-the-ground and weight of evidence in the Syrian crisis shows that parties on one side of the conflict – Syrian government forces and their allies in the air and on the ground – are committing the vast majority of violations. Failure to acknowledge this imbalance is academically, ethically and philosophically bad practice. The conclusion by Sen and colleagues that ‘the Syrian conflict urgently needs a reassessment of research ethics’ is out of touch with the urgent need for the Syrian government and its allies to cease targeting civilians, stop attacking healthcare facilities and lift the siege on over one million civilians.
The comparison of national vs. WHO essential medicine lists (EML) with respect to medications used in pediatric endocrinology by Rowlands et al. highlights an important health care delivery gap for children with endocrine disorders.
However, as the authors correctly point out, accessibility is far more limited than reflected by the EMLs. We argue that many medications listed on EMLs are not actually available to most patients in resource-limited settings and that all five dimensions of access including availability, affordability, accessibility, acceptability, and quality (1), are suboptimal for medications relevant to pediatric endocrinology. While EMLs may be a rough surrogate of availability, as a metric they cannot take into account stock-outs and limited numbers of pharmacies carrying the medication, both frequent occurences in resource-constrained settings. Similar to cardiovascular medications (2), limited affordability is a major access barrier in a country like Haiti where close to 60% and 25% of the population live under the national and extreme poverty lines, respectively (3). Accessibility adds to the barriers where pharmacies are distant from patient residencies, acceptability can be challenging in cultures where traditional practices are common, and quality of medications may vary widely in settings with little regulatory supervision and compliance. A case in point is propylthyrouracil, a drug that carries a black box warning (4), which is on the EML,...
The comparison of national vs. WHO essential medicine lists (EML) with respect to medications used in pediatric endocrinology by Rowlands et al. highlights an important health care delivery gap for children with endocrine disorders.
However, as the authors correctly point out, accessibility is far more limited than reflected by the EMLs. We argue that many medications listed on EMLs are not actually available to most patients in resource-limited settings and that all five dimensions of access including availability, affordability, accessibility, acceptability, and quality (1), are suboptimal for medications relevant to pediatric endocrinology. While EMLs may be a rough surrogate of availability, as a metric they cannot take into account stock-outs and limited numbers of pharmacies carrying the medication, both frequent occurences in resource-constrained settings. Similar to cardiovascular medications (2), limited affordability is a major access barrier in a country like Haiti where close to 60% and 25% of the population live under the national and extreme poverty lines, respectively (3). Accessibility adds to the barriers where pharmacies are distant from patient residencies, acceptability can be challenging in cultures where traditional practices are common, and quality of medications may vary widely in settings with little regulatory supervision and compliance. A case in point is propylthyrouracil, a drug that carries a black box warning (4), which is on the EML, while the safer antithyroid medication, methimazole, is not.
The Pediatric Endocrinology Education Program for Haiti, supported by the Pediatric Endocrine Society and the European Society for Pediatric Endocrinology, aims to introduce pediatric endocrine care to a country where no pediatric endocrinologist currently practices. Unpublished data from teleconsultations as part of this program demonstrate that the majority of children diagnosed with endocrine disorders do not have access to the medications they need – even if these are listed on the national EML. For example, hydrocortisone and fludrocortisone, essential medications for children with adrenal insufficiency, are on Haiti’s EML but were unavailable despite extensive searches. Even inexpensive medications such as levothyroxine and routine supplements such as calcium carbonate and vitamin D2/D3 are often difficult to find and calcitriol is entirely unavailable. The list of inaccessible medications is long, including vital medications such as growth hormone and diazoxide for neonatal hypoglycemia.
Maybe most reflective of the alarming situation is access to insulin. While listed on all EMLs, the reality of children who are diagnosed with diabetes is different. The Kay Mackenson Clinic, a center for children with chronic diseases in Haiti, recently assessed the availability of insulin in Haiti and showed that close to one third of patients do not have access to insulin at the time of diagnosis and close to half lack access to insulin after they are discharged from the hospital following initial diagnosis (5). Further, long-acting and ultra-short acting insulin analogs, mainstay of therapy for intensive diabetes control, are virtually inaccessible.
Inequities in access to essential medications in pediatric endocrinology remain unacceptable. The comparison of EMLs by Rowlands et al should stimulate further research into actual accessibility, including its predictors and barriers.
References:
1. Penchansky R, Thomas JW. The concept of access: definition and relationship to consumer satisfaction. Med Care. 1981;19:127–140.
2. van Mourik MS, Cameron A, Ewen M, Laing RO. Availability, price and affordability of cardiovascular medicines: a comparison across 36 countries using WHO/HAI data
3. http://www.worldbank.org/en/country/haiti/overview
4. http://www.fda.gov/Drugs/DrugSafety/ucm209023.htm
5. von Oettingen J, Carolan E, Jean-Baptise E, Larco N, Larco P, Ogle G, Lorgeat V, Mascary M, Bonnell R, Carpenter C. (2016). Health care delivery gaps affect children with new onset diabetes in
We thank Cooney and Partridge for their interest in our article.1 We believe, however, that they have misunderstood much of what we wrote. We accessed websites with publicly available national and subnational data on population-level rates of religious affiliation and breastfeeding initiation. As we explained, two other selection criteria reduced the number of countries we examined: (1) sufficient within-population variability in both religious affiliation and breastfeeding initiation and (2) data on both variables, so that they could be associated at the same ecological (geographical) level. As we acknowledged, we did not find Lander-level data for Germany, the country that best met our selection criteria. Our inclusion of data from French-speaking regions is clearly a strength of our study--not a limitation. We used Protestant affiliation as defined in the databases we found, and we focused on the major Protestant groups in the general population. Since the data we used are publicly available, we invite Cooney and Partridge to analyse the associations between minor Protestant groups and breastfeeding rates in Ireland. Regarding the definition of Protestants, any degree of misclassification should have reduced, rather than increased, the associations we observed. Our scatterplots show the crude (unadjusted) data together with the crude correlations. For France, Ireland, the UK and Canada, crude and adjusted results were all in the same direction: a negative correlation be...
Show MoreDrs. Dadhich and Prasad raise important issues in their comments and questions about our study on home-based management of children with uncomplicated severe acute malnutrition (SAM). We are grateful for the opportunity to respond to them.
In our view, there are two distinct goals in the management of children with SAM. The first, and more urgent, is to treat and move them away from severe malnutrition, a state of high risk of death. The second is to rehabilitate them to the point they are no longer malnourished. The treatments examined in the study achieved the first goal well. By the end of the treatment phase, 84.5% of the children in the RUTF-L group were no longer SAM. However, they did less well in achieving the second goal. By the end of the treatment phase, 57% of those receiving RUTF-L had recovered to the point of no longer being malnourished. Should we have applied the same approach as most studies to calculate their WHZ - using height at enrolment and current weight, rather than concurrently measured height and weight - 81% of the children in the RUTF-L group would no longer be classified as malnourished by the end of the treatment phase.
We note Dr. Prasad’s misunderstanding that over 40% of the children in our study remained SAM by the end of the treatment with RUTF-L. Should her interpretation have been correct, it would justify her expressed concern. However, as stated above, by the end of the treatment phase 84.5% of the c...
Show MoreMedicines supplied in low and middle income countries are a matter of concern especially in regard to their quality. This article has raised a very genuine issue regarding the quality of medicine supplied to low and middle income countries(Nebot Giralt et al. 2017). This comment has been written in context to Nepal, a low income country as per the World Bank classification with population of around 28 million, out of which around 25 % of the people are living below the poverty line and 80% of the people living in rural areas(Central Bureau of Statistics 2015). The current ongoing Mass Drug Administration (MDA) for Elephantiasis in Nepal as a target to eliminate filariasis by 2020 has not been able to achieve its target due to poor compliance to the medicine. One of the reason could be due to people questioning about the quality of medicine distributed by government which could be the result of news spread five years back which stated five deaths, which later on was declared MDA not being the cause of death and more than 800 people falling ill after taking the medications. But still the fact cannot be ignored without proper investigation(Pandey 2012).
Show MoreStill, many regions of the country lack access to basic health facility and essential medicine. The government of Nepal as per the national health policy has listed around 70 different drugs like anti-viral, anti-protozoal, some drugs for non-communicable diseases and so on to be distributed free of cost. The few p...
Abdur Sarker et al have highlighted an incredibly important aspect of Bangladeshi society that acts as a pivotal part of achieving Universal Health Coveage (UHC). They have clearly highlighted aspects such as the promotion of health equity and access within cooperatives, however, two aspects of such societies have not been discussed, namely technology and education.
Reading Between the Lines of the RUTF trial, India
Show MoreNita Bhandari et al are to be congratulated for publishing the much-awaited findings of the trial conducted in India for home-based management of uncomplicated severe acute malnutrition; comparing the efficacy of ready-to-use-therapeutic-food (RUTF); centrally (RUTF-C) and locally produced (RUTF-L), with augmented home-foods (A-HPF). The rigorously conducted trial offers significant insights to this highly debated and discussed area of work i ii . However, its policy recommendations seem evasive and ill founded on the evidence.
It is hardly in question that children with SAM benefit from being fed calorie-dense and protein rich foods, including RUTF. What the authors note, however, is that the rate, ease and extent of achieving ‘cure’ is far lower than that seen in African studies. In fact, this is the first trial where the advisory committee – the Data Safety Monitoring Board has had to recommend a treatment period as long as 16 weeks. It also has had to recommend the introduction of paid workers that visited each household ‘several times’ through the day to personally supervise feeding, to be able to achieve even this impact across the arms. This corresponds to an understanding that malnutrition cannot be sufficiently countered in the field without supporting care-givers in practical ways. In fact, comparing ready-to-use foods with the raw material that was supplied...
‘The nationalist not only does not disapprove of atrocities committed by his own side, but he has a remarkable capacity for not even hearing about them’ (George Orwell, Notes on Nationalism 1945).
We read with concern Sen and colleagues’ discussion of potential breaches of ethical neutrality in the reporting of events in Syria by Non-Governmental Organisations (NGOs) and academic researchers. We fully concur that any research must be based on rigorous methodologies and robust ethical frameworks. However, when engaging in debates on ethics and critiques of existing research one should adopt a morally reflexive position and consider all the evidence that exists no matter who has produced it.
Over the past five years a large body of evidence from credible humanitarian and international organisations has been accumulated which clearly documents the use of chemical weapons, heavy weaponry, ballistic missiles, cluster and barrel munitions deployed by Syrian Arab Army (SAA) forces and its allies. It is unfortunate that in the Syrian context, no side has spared civilians or prioritised the protection and well-being of civilians. Human rights abuses have been carried out by all sides. However, abundant evidence exists that the SAA have been largely responsible for the mass of civilian casualties. A major study in the British Medical Journal of the causes of mortality in Syria attests to this. Since September 2015 the SAA has been assisted by the Russ...
Show MoreThe comparison of national vs. WHO essential medicine lists (EML) with respect to medications used in pediatric endocrinology by Rowlands et al. highlights an important health care delivery gap for children with endocrine disorders.
However, as the authors correctly point out, accessibility is far more limited than reflected by the EMLs. We argue that many medications listed on EMLs are not actually available to most patients in resource-limited settings and that all five dimensions of access including availability, affordability, accessibility, acceptability, and quality (1), are suboptimal for medications relevant to pediatric endocrinology. While EMLs may be a rough surrogate of availability, as a metric they cannot take into account stock-outs and limited numbers of pharmacies carrying the medication, both frequent occurences in resource-constrained settings. Similar to cardiovascular medications (2), limited affordability is a major access barrier in a country like Haiti where close to 60% and 25% of the population live under the national and extreme poverty lines, respectively (3). Accessibility adds to the barriers where pharmacies are distant from patient residencies, acceptability can be challenging in cultures where traditional practices are common, and quality of medications may vary widely in settings with little regulatory supervision and compliance. A case in point is propylthyrouracil, a drug that carries a black box warning (4), which is on the EML,...
Show MorePages