CKDu in Sri Lanka - has the management of the disease improved?

CKDu in Sri Lanka - has the management of the disease improved?

Amarasiri de Silva, PhD (Formerly Senior Professor in Sociology at the University of Peradeniya)

The two principal areas of research into CKDu - that based on data collected from people in the community, and that based on patient data available in hospitals - are pursued entirely separately in our country. The field research is field research and the hospital-based research is hospital-based research, and it seems that, in Sri Lanka, never the twain shall meet. CKDu researchers often derive their own data from field investigations, but are either not allowed to or have not attempted to make use of hospital data as sampling frames to draw their field samples for research. On the other hand, the patient data in hospitals are analysed (mostly by doctors), without linking them with the community perspectives of the patients. Therefore, readers of such research often have to grapple with the problem of linking the two sides of the story - the treatment and disease management aspects with the socioeconomic or community issues.  In other words, the link between the community and the hospital is almost absent in CKDu research. Often, CKDu patient data in hospitals in Sri Lanka are regarded as the 'exclusive property' of the doctors, and they are not shared with other scientists, especially with social scientists, who would like to use such data towards improving public health. This has given rise to a dire situation in CKDu research in Sri Lanka as the opportunities for mutual benefit and understanding between hospital-based research/data and community-based research/data are virtually absent. This unhealthy compartmentalization has prevented a comprehensive understanding, particularly when regarding CKDu as a problem in the community rather than only at the level of the individual patient.  

Despite this duality, researchers have contributed in their own way to build up a narrative or a discourse on CKDu, which has helped to lead the public towards a medicalized understanding of the issues that surround CKDu. As a result, people in affected communities tend to look at CKDu as a disease caused by polluted water and environmental contaminants such as pesticides and herbicides. Hospital doctors, however, have not been able to convince the public that hospital attendance for CKDu is beneficial, particularly that early diagnosis and treatment can relieve most of the problems associated with the later stages of the disease.  Moreover, many people who are in the final stages of the disease do not attend hospitals regularly: when the disease becomes severe and debilitating, they discharge themselves from hospital, and suffer and die in a few years in their own communities, because all that's wrong in health care and hospital system [studies show such patients in their end-stages die within two years after they are diagnosed].

Since the disease was first identified in the 1990s, about 65 articles have been published in peer-reviewed journals - a commendable achievement in terms of investigating the phenomenon from different perspectives. An article or news item related to CKDu appears in the media almost every week, often based on scientific articles and mediated to cater to the needs of the general public. Public awareness of the disease is pretty high within the affected areas as well as in the country generally, largely due to the contribution of the media and the work of local health departments.

The health ministry has taken many steps to improve preventive measures pertaining to the disease, and to care for CKDu patients in the affected regions. Among these, allocating more funds and providing better facilities, such as nephrology clinics, trained doctors (nephrologists) and nursing staff, etc. seem important. As I was informed by Dr. Tilak Abeysekera (Consultant Nephrologist, Nephrology Dialysis and Transplant Unit, Teaching Hospital, Kandy), 23 nephrology clinics have been set up by the government in NCP.  In the early 2000s, about 4% to 5% of the country’s health budget was spent on the treatment and management of CKDu patients [as Dr P.G. Mahipala, Director General of Health Services, presented at the symposium on CKDu in 2014, organised by the National Academy of Science. This is a significant proportion and more that the proportion spent on higher education!]. Since then, the need for facilities such as nephrology clinics, dialysis machines and a trained medical work force has been highlighted by the news media, activists, and doctors. The outcomes of these efforts are commendable as well as disappointing.

First, there has been an increase in attendance at clinics for CKDu checkups, which is commendable. Attendance at the Renal Clinic at Anuradhapura Teaching Hospital rose from 10,921 persons in 2004 to 15,889 persons in 2009, a 46% increase over 5 years. However, given that the disease affects between 15 and 20% of the population in the region (according to the WHO) [assuming that the rates prevailed in the five year period], these numbers represent only the tip of the iceberg. The number of confirmed CKDu patients at the Anuradhapura Clinic rose from 1,327 in 2004 to 4,975 in 2009, a huge 275% increase.  This indicates an increase in the total number of CKDu patients in the villages over the five-year period, but also a growing awareness among the people of CKDu of its symptoms, and the need to visit hospitals for checkups and treatment. The latter are positive developments and indicators of the effectiveness of the media and the implementation of the educational programs conducted by the local health department through village health committees.

The mortality rate among CKDu patients in Anuradhapura hospital fell from 10.6 % in 2004 to 4.5% in 2009. One could argue that the decrease in mortality rates reflects improvements in treatment and in the quality of care in the hospital-based CKDu healthcare system in the affected districts.  However, this data should be treated with caution, since they do not reflect the overall rates of CKDu deaths in the region: as pointed out earlier in this article, many end-stage CKDu patients withdraw from the hospitals and die in their own communities. This is a tragedy. Hospitals should invest in treatment programmes to make them attractive and patient-friendly. Provision of adequate number of dialysis machines, hospital beds, and facilities for a family member to stay with the patient, provision of meals and medicine freely as the patients cannot afford to pay are some quick measures to attract the patients to hospital treatment. Unless CKDu patients are confident that hospitals can look after them and treat them well, particularly in the later stages of the disease that require haemodialysis and close monitoring, they will not visit the hospitals, and will not adhere to hospital-based treatment regimens.

In its 2010 annual action plan, the health ministry claimed that CKDu was a serious concern, and identified many programmes for future implementation. It is the responsibility of the CKDu Task Force set up under the guidance of the President to monitor the progress of these programmes, if targets for CKDu management and care are to be achieved. There should be a monitoring unit attached to the Task Force to oversee the effective implementation of the recommended programmes.  The ministry has suggested utilizing funds to establish nephrology units in the affected districts [may have been used to set up the 23 units referred to above], to recruit nephrologists for these units, to conduct screening programmes in all high risk areas, to amend to the WHO guidelines enabling tissue transplantation, and to set up a better follow-up system ensuring organ donor and recipient safety. It is important that the Task Force should evaluate the progress of these suggested programmes. In addition, health ministry requested support from the WHO, and this developed into a collaborative research effort between the health ministry, WHO and the National Science Foundation. The detailed findings of this project have been compiled and submitted to the government, which was expected to initiate action based on the recommendations. However, we do not yet know what actions have been taken by the government in response, so what is the Task Force doing about these recommendations?

We need to understand that CKDu is a disease that affects people’s way of life.  It is a disease in the community as much as a disease that affects the individual. We all know that a doctor, if he or she is a concerned medical practitioner, will invest a few minutes to inquire about the patient, his or her background, occupation, etc. to enable a better diagnosis and assessment of the health condition of the patient. The social background of the patient is indisputably an important aspect of any treatment regimen. In most western countries, social aspects of health and disease are considered important parts of medical education curricula.  When dealing with a community-wide disease, such as CKDu, it is imperative that a strong link between the community and the medical profession be forged in such a way that patients and their families gain confidence in hospitals, doctors, nursing staff and the treatment regimen.   

Unfortunately, biomedical research on this complex syndrome has achieved little over the last 25 years, and one cannot say that there has been much progress in relation to either the causes of the disease or its management. The President in his speech on 20 August, 2015 at the inauguration of the Kidney Fund said that 'all these responsibilities cannot be solved by any ministry or institution alone’, and emphasized ‘that the programs should achieve their objectives with the participation of everybody for the future of this country'. In that context, it is the responsibility of the President, the CKDu Task Force, and the doctors in nephrology clinics to be more open and accommodative and to be prepared to share patient data and harness the positive contribution and constructive criticisms of all those who have a dedicated interest in this national tragedy.  

The CKDu picture in Sri Lanka is certainly confusing

The CKDu picture in Sri Lanka is certainly confusing

Amarasiri de Silva, PhD

In a bid to seek assistance from friendly countries to combat kidney disease, the President of Sri Lanka stated in a recent meeting that about 40, 000 people were suffering from kidney disease of unknown etiology (CKDu) and that approximately 1000 persons succumbed to the disease annually (Island July 29). He further stated that even though steps were taken to improve the facilities in hospitals that attend to such patients, the number of patients was still on the rise. The inability of the government to tame the disease is partly due to the poor attention paid by the scientific community to understand and explain the socio-cultural aspects of the disease. 

The failure to take account of sociocultural factors in research so far carried out on CKDu in Sri Lanka is responsible for the present confusion and lack of understanding about the disease. Biomedical and epidemiological scientists have led us astray by their emphasis on the search on etiologies, and so the whole phenomenon remains an unduly difficult one to comprehend. The scientists themselves have accepted this confusion and continue to assign a ‘u’ at the end of CKD to denote the unknown nature of the etiology of the disease.

While focusing on environmental and other factors such as water pollution, the use of fertilizers and pesticides in agriculture, snake bites, the use of aluminum utensils, and heredity in their analysis of CKDu, the researchers have forgotten the human face of the disease. They often saw the persons affected by such environmental nephrotoxins as patients – CKDu patients in their 4th and 5th stages. Often, they merely analyzed urine and blood samples, and carried out kidney autopsies. The most important aspect of these patients – their personhood, their humanness, their social relationships and culture – were completely forgotten in carrying out this scientific research. These studies have failed to see who these ‘patients’ were, what activities, and behaviors they engaged in, the social groups they belonged to, the predicament that made them members of certain social groups that were affected by the disease. Why it is that predominantly men in these groups get affected by this disease? Why do many women in these groups not progress towards end-stage CKDu? In order to understand how CKDu is structured in agricultural societies in South Asia and Mesoamerica, it is important that we provide answers to these behavioral questions.

Although scientists vary in their opinions on the etiology of the CKDu, they all agree that the occurrence of the disease is a result of the interface between humans and their living and working environment. This interface is often seen in people who depend on the environment for their livelihoods. The link between environment and livelihoods can be understood only if we study how people make use of the environment. In other words, what are the behaviors that people are engaged in, in order to exploit the environment for gain?  In the areas where CKDu is prevalent, what distinguishes those who are affected from those who are not?

Following well-structured scientific procedures with high technology, rigorous methodologies and laboratory experiments aimed at isolating etiologies is pertinent if CKDu is found in all segments of society. However, the story of CKDu in Sri Lanka as well as other affected areas in the world is that it is found in pockets or ‘islands’. This shows that CKDu occurs in specific social settings.  The simple question we have failed to ask so far is why this disease occurs in certain social groups and not in others. The scientists have never asked who these CKDu patients are; where they come from; what they do for a living; and whether those affected share common social and cultural characteristics. If we were able to answer these simple questions, we would also be able to address many of the challenging issues surrounding CKDu.  So far, these questions remain unanswered.  

The article published in BMC Nephrology by Jayatilake et al in 2013 (Chronic kidney disease of uncertain aetiology: prevalence and causative factors in a developing country) is the published form of the widely discussed WHO study on CKDu in Sri Lanka. Although involved a huge investment in research, this investigation did not provide a comprehensive understanding of CKDu, partly due to its inability to answer these sociocultural questions and the failure to comprehend the behavioral component of the disease. It is important to consider why it failed to incorporate the sociocultural and behavioral components into the analysis.

A cross-sectional study: Although Jayatilake’s article is based on a cross-sectional study that randomly selected 100 households from twenty-two villages in three districts, it failed to discuss how the study brings into focus the social and cultural makeup of the village communities and agricultural resettlements in the affected districts. No description is given of the type of villages chosen, or how they represent different socio-cultural zones of the affected districts. An analysis of community types, in both case and control groups, is necessary, as CKDu is socially and culturally situated in certain segments of the affected districts. One could argue that, since ‘patients’ were randomly selected from the affected districts, they would inevitably include people from all walks of society. But the problem is that the sample was not broken down into socio-cultural groups and, therefore, the most important variables of such groups were not included in the analysis.

Prevalence: The overall prevalence of CKDu was 15.3% with a higher prevalence in females (16.8%) than males (13.3%) (p < 0.05). More severe grades of CKDu were seen more frequently in males (grade 3: males vs. females =19.9 vs. 5.3%, grade 4: males vs. females = 16.1 vs. 3.8%).  In both sexes, prevalence was higher with increasing age (p < 0.05). This shows that less severe grades were more prevalent in females. If so, with age increase will there be more females with severe stages of CKDu? The article states that male sex has been reported to be a risk factor for progression to end-stage renal disease. This is interesting but the article does not elaborate on this very important behavioral factor associated with male farmers. If this aspect were dealt with, it would have brought in important socio-cultural factors associated with CKDu.

The magnitude of the affected population as discussed in this publication becomes questionable. For example, based on 15.1% prevalence rate, how do we square the figure of 129,291 people affected in Anuradhapura alone (the prevalence rate of CKDu in Anuradhapura District as mentioned in the article was 15.1%), as implied by the WHO study, with the much lower numbers reported for hospital attendance? Are we really to believe that, in a country such as Sri Lanka where seeking medical treatment is a well-established practice, so many people affected by the disease refrain from going to hospital? This would suggest that, taking Anuradhapura alone with a total population of 856,232 (Census and Statistics 2011), the CKDu positive population increased from around 21,000 in 2011 (based on data provided by Chandrajith (2011) where prevalence of 18 years and over was 2-3%) to over 129,291 in 2012, a 516% increase over one year.

The WHO data indicate that the prevalence of the disease is higher among females, but this is not corroborated by any other research carried out so far. Demographic information collected by Jayasekara et al (2013) from Northern Region clinics, covering 11,323 patients, shows that the male: female ratio among those suffering from the disease was 2.4:1. Other published research also shows that males form the majority of the affected population. A review of published findings from El Salvador, Nicaragua, Costa Rica, Sri Lanka, Egypt and India (Almaguer et al 2014) shows that prevalence was generally higher in male farmworkers aged 20–50 years.

The samples were drawn from three locations for the cross sectional study. They were the CKDu confirmed patients from CKDu affected locations, non CKDu people from the affected locations and a third sample from Hambantota, which is a non CKDu affected area. However, the research design did not allow a sample of CKDu patients from a non-affected area. The 4^th category is important as the disease is now spreading into newer locations beyond areas that are already identified as high incidence locations.

CKDu and Occupation: When separate logistic regressions were run for each potential exposure, only occupation type (being a farmer increased odds by 19.5%) and type of agriculture (paddy cultivation compared to cultivation of vegetables and other crops decreased odds by 26.8%) were shown as significant. Most important to see how means of production of people in these farming communities are related to CKDu. In an agrarian society such as rural Sri Lanka, the means of production are the soil (land) and the plough (labor). The fact that whether these farmers own land, if so how much or whether they were owner farmers or they were wage laborers was not mentioned. However, the fact that those who cultivated chena land (highland for vegetables – slash and burn cultivation -- being a chena cultivation farmer increased the OR by 19.5%, while engaging in paddy cultivation compared to cultivation of vegetables and other crops [chena cultivation] decreased the OR by 26.8%) had the higher rate of CKDu. This shows that the disease was higher in percentages among poor slash and burn farmers who do not own or own only a little paddy land and were poor laborers. This is a very important aspect, and if analyzed would have given much needed socio-cultural information on the social standing of the affected people (more than just patients) and their socio-cultural location in the communities.

The article concludes that ‘the risk was reduced in individuals who were male or who engaged in paddy cultivation (OR = 0.745, 95% CI = 0.562 to 0.988 and OR = 0.732, 95% CI = 0.542 to 0.988 respectively, P < 0.05). This is misleading for the very fact that paddy cultivation is regarded as one simple variable in the analysis. Paddy agriculture is a complex variable, which has many different forms, which cuts across land ownership, type of tenure and wage labor. Paddy agriculture constitutes many types such as owner farmers, wage laborers, tenants, lessees, partnership caretakers and mortgagers etc. If the variable paddy agriculture were fragmented into simple variables of different types of paddy agricultural work, picture would have been different and more realistic. However, a majority of studies show that there is a link between paddy agriculture and CKDu. Most critical statements made in the article says ‘…In the present study, older age, being female and being a chena cultivation farmer increased the risk of CKDu’ (p9). In simple language, it says that the females who are older and engage in chena cultivation display a high risk for CKDu. It would have been good if age related odd ratios were provided in Table 2 to better understand the argument. In Table 2, none of the OR were significant with years of engagement in agriculture is interesting, and one would therefore, tend question the validity of the above statement that being an older age female chena farmer is a risk for CKDu.  Table 1 on page 3 says the mean Age (years) of CKDu patients was 39.1 (SD14.2). In 2013 Jayasekara et al, in a study of 796 and 67 patients from Padaviya and Nikawewa respectively, conclude that the mean age of CKDu patients was 54.7 years. Two years after studying three cohorts of population in the North Central Province, Jayasekara et al (2015) were able to establish reliability of the mean age statistic of CKDu patients as 54.7 years. It is problematic for the reader to understand why the WHO study deviated from other studies with respect to the mean age of CKDu patients and the identification of gender of the majority of patients.

Ground water and CKDu: The article says ‘CKDu occurs in areas where groundwater is the main source of drinking water’, but failed to account for this factor. The only thing that they say is that it may be because of high concentration of fluoride in ground water. They borrow findings from other researchers to support their hypothesis, but their study did not invest in testing out this hypothesis. This explanation is a camouflage used by the article to hide their inability to prove cadmium availability in excess of the recommended amounts in well water. The faults in sampling of wells for water testing has created this situation in this study. The study by Jayasumana et al (2015) examined water quality of abandoned old wells in the endemic areas and found that they had a very high cadmium content in water.

The lessons we learn from this critique of the WHO study are many. First, it is important to explore the social and cultural characteristics of the affected population. Especially when a disease entity is affecting a particular region and a social segment of the society one of the first steps is to find out who these people (as opposed to patients) are, why they are prone to this particular disease. Second, we must recognize the importance of both social and cultural dimensions in delineating etiologies, and, therefore, research of this nature must be multi-disciplinary. There should be complete exchange of data and findings among different researchers from wide array of disciplines. Assigning a sociocultural component of the study to an isolated group, as in the case of the WHO study, would not bring the socio-cultural aspects of the disease into central focus.  The article we reviewed showed that the sociological study of the WHO project did not lead to deep understanding in the final published document of the project, apparently because of absence of exchange of fundamental ideas and data between the groups. Finally, pursuing etiologies prior to a sophisticated social and cultural analysis (or risk factor analysis as epidemiologists say) of the regional problem is premature in disease entities such as the CKDu which are regionally and socially confined diseases. In order to better serve the purpose of evidenced based policy and programming in diseases that are localized in certain communities, it is necessary that the researchers should have a better informed community focus in their research.