A startling new study that surveyed 700,000 people in Raigad and Mumbai suggests that the burden of leprosy could be three to nine times the official figures. Obviously, people are not being detected and treated in time. Are the misguided policies of the National Leprosy Elimination Programme leading to a public health failure?
More than half of the world’s estimated 213,000 patients with leprosy live in India. This bacterial infection is curable with proper antibiotic treatment. Untreated, it can cause permanent damage to the skin, nerves, limbs and eyes.
The stigma associated with leprosy has been a major hindrance to eliminating it as a public health problem. People identified as having leprosy are shunned by their families, forced to live separately and denied participation in community and religious activities. They find it almost impossible to get work. Consequently, people with symptoms often hesitate to seek treatment until they suffer deformities and disability. The law is not supportive of leprosy patients: the infection is grounds for divorce and in September last year, the Supreme Court actually upheld a law that leprosy patients cannot contest elections.
Still, India has had a leprosy control programme for more than 50 years. This period has seen the development of new, effective drugs and extensive research into the transmission and treatment of the disease. Major programme changes include the involvement of non-governmental organisations and integration of this vertical disease control programme into the general health services.
However, a recent study by the Mumbai-based Foundation for Medical Research (FMR) suggests that misguided policies of the National Leprosy Elimination Programme (NLEP) – conducted in accordance with WHO guidelines – are leading to a public health failure.
Official figures underestimate the problem
The FMR’s population-based study in rural and urban areas of western Maharashtra found that the actual prevalence of leprosy was three to nine times the official reported figures for these areas. The information from the survey indicates that not only is the burden of leprosy underestimated, the transmission of infection is actually very high. The researchers indicate that if the government does not make changes in its current strategy, leprosy will continue to be transmitted in vulnerable populations with all the medical, social and economic disabilities that it entails.
“The high rate of new infections in children is particularly worrying,” says Dr Vanaja Shetty, senior scientist and lead author of the study which was published in the January 2009 issue of Leprosy Review and presented at a dissemination meeting in Mumbai in February 2009. “Thirty-five per cent of the patients we found were children. Child infection is an indicator of recent, active transmission, whereas adult infection could have been incubating for years. On the other hand, the high rate of grade 2 deformity found in the study – six times the official figures – indicates that people are not being detected and treated in time. Is the government’s strategy to educate people for voluntary reporting not working?”
Discussions with researchers and health workers indicate that a combination of policy decisions has led to this situation. House-to-house case finding has been replaced with “voluntary reporting”; the government will focus on generating awareness to encourage people with symptoms to seek healthcare. New case definitions and treatment practices have dramatically reduced the number of registered patients officially under treatment – though some of these can be infectious diseases. Effective diagnostic tools have been discarded. Finally, the programme has been integrated into general health services without adequate training and infrastructure, forcing patients to run from pillar to post for treatment of any sort.
Findings of a population-based survey
The FMR study was conducted in Panvel taluka, Raigad district, and the M East ward in Mumbai. Health workers of the non-governmental organisations Kushth Nivaran Samiti and Lok Seva Sangam screened 700,000 adults and children (more than 85% of the population) in the selected areas of Raigad and Mumbai. A total of 210 people were diagnosed as having leprosy.
According to government figures, the prevalence of leprosy in these regions is 1.37/10,000 in Panvel and 0.9/10,000 in Mumbai. The FMR study found a prevalence of 6.72/10,000 and 2.61/10,000 respectively.
Ninety per cent of those diagnosed with leprosy were newly detected – they had been missed by the government programme. More than one-third (76) had the more infectious multibacillary (MB) disease which requires 12 months treatment, longer than paucibacillary (PB) disease which get six months treatment*. The majority (19 out of 24) of smear positive cases were highly infectious. Up to 12% had grade 2 disability – compared to the government’s official figure of 2-4%.
The NLEP does not include single skin lesions (SSL) patients in its registry of patients under treatment, listing them in a separate “zero registry” that does not count towards the country’s reported prevalence of leprosy. These patients are categorised as PB cases and given six months of treatment.
In the FMR study, 13% of people with single skin lesions were smear-positive and infectious. They should receive the complete 12-month treatment. However, government guidelines do not require smears for diagnosis and these people would have been given six months of treatment – if they had reached the public health services.
The authors note that such under-treatment under the NLEP “not only deprives the patients of timely treatment and prevention of deformity but also promotes transmission of leprosy in the community through multibacillary single lesion cases.”
The story behind the underestimates
In 1991, the World Health Assembly resolved to “eliminate leprosy as a public health problem by the year 2000”. Elimination was defined as a prevalence of less than one case in 10,000 people. However, in 2000, India was one of 12 countries with a prevalence of more than 1/10,000 and accounted for 64% of the estimated global burden.
So we should be surprised to hear that by 2005, India’s National Leprosy Elimination Programme reduced the prevalence of leprosy by 80%. What sleight of hand led to this dramatic reduction?
Starting in 2001, the government’s National Leprosy Elimination Programme instituted a series of measures supported by WHO guidelines. Single skin lesions (SSL) were deleted from the government’s registry and new SSL cases were not recorded. (Patients above the age of 50 are also not included in the registry.) “Workers were also reluctant to register new cases because they were taken to task if the prevalence went up,” says Dr V V Dongre, senior consultant, ALERT India, a Mumbai-based NGO working with leprosy diagnosis and treatment.
The use of microscope smears for diagnosis and monitoring was stopped, under the excuse that the necessary microscopes, trained personnel and disposables were not available. Patients who had completed a fixed period of treatment were “released from treatment” without verifying through smear tests that they had been cured. Follow-up of treated patients to monitor for drug reactions or relapse was stopped. Treatment time for MB leprosy was reduced from 24 to 12 months (in 1998). The active new case detection programme was replaced by a voluntary reporting system by which community awareness programmes were meant to bring patients forward for diagnosis and treatment.
“These decisions were not based on evidence,” says Dr Shetty. “Cure was earlier defined according to smear negativity. In 2000, it became 24 months of treatment. In 2005, this was reduced to 12 months. Now there is actually a trial for six months of MDT for all cases regardless of the diagnosis.”
But the strategy achieved its goal.
By 2005, India’s National Leprosy Elimination Programme was reported to have reduced the prevalence by 80%. Much of this drop in prevalence was obviously due to the changing definitions of the disease and of cure. Many of the people taken off the government’s registries suffered the burden of disease and deformity, with its medical, economic and social consequences. Unfortunately for these people they no longer existed as far as the government was concerned.
(The official numbers are further distorted because the private sector – which provides more than 75% of healthcare – does not report cases to the government registry, and private practitioners follow their own, sometimes irrational, treatment practices.)
Such statistical sleight of hand was challenged when it was first discussed in the early-1990s. Health workers pointed out that a drop in prevalence (existing number of cases on the registers) without a drop in incidence (number of new cases each year) meant that people were being infected at the same pace.
The consequences of government policy
“If you see the graph of new case detection rate of any area, you will see a steep downgrading from 2003 to 2005,” says Dr Dongre. “This is because they wanted to declare leprosy eliminated at the national level. Yet when we visited a tribal hamlet in Karjat recently, within half-an-hour our health worker identified 18 untreated leprosy cases. This is happening at many places.”
Indeed, in 2007 India registered a decline of only 1% in the number of new cases over the previous year. While the figures for 2008 are not yet in, health workers say that there may actually be an increase in incidence of leprosy because of the government’s policies.
Dr Shetty is dismayed by the government’s dispensing with diagnostic tests. “The smear is a useful and simple tool at the field level for treatment and follow-up. Smear-positive cases are more infectious and also at higher risk of reaction –for which you need to follow up with the patient. They dropped the smears saying the quality is poor because of inadequate equipment and materials, but this is not a scientific decision. They should have improved the quality of smears.”
Many patients receive incomplete treatment because of the government’s decision to stop treatment without confirming that the patient is cured. “Many of the patients we see are relapsed because of incomplete treatment,” says Dr PSS Sundar Rao of The Leprosy Mission with 18 centres across the country. “Patients are being discharged even when they are smear-positive because the treatment regimen requires it.”
Routine post-treatment follow-up of patients has been stopped. Dr Dongre points out that such routine surveillance picks up on post-treatment deformities and relapses. “Deformities are the root cause of stigma. Deformities and relapses may be statistically insignificant in a mass programme but for the individual it is important.”
A point made again and again by health workers is that voluntary reporting is just not working. A study by ALERT India found that 86% of newly detected cases did not approach the health system even if they had symptoms. A survey by the Leprosy Mission with 18 centres across the country found that the majority of patients who approached treatment centres did so only when the disease had caused deformities that affected their lives.
In 2003-04, leprosy services were integrated with other health facilities. “This is a good idea, but it was done without first providing the necessary training and infrastructure within these services to diagnose, treat and follow up,” says Dr Dongre. “As a result, patients are running from pillar to post.” The problem is compounded by the dismal state of public services in India. “At several places even the drugs are not available. As a doctor, I have no right to say, ‘You have leprosy but I don’t have the drugs to treat you.’ I move in districts where patients come from a long distance for treatment but eventually lose interest and go without treatment.”
Efforts to treat leprosy as a public health problem are confronted with multiple challenges—stigma, lack of awareness and lack of access to healthcare.
An analysis allied to the FMR survey found that many of those newly diagnosed with leprosy had not even heard of it. Even if they were aware of the symptoms, many did not seek care for over a year after they developed symptoms, partly because of the stigma associated with the disease. Tribals were less likely to seek help, possibly because of their reduced access to healthcare.
In this situation, what are the chances that people with symptoms will approach health services for early detection and treatment? The stigma attached to leprosy is such that patients are disowned by their families and societies. They are expected to somehow obtain treatment from a healthcare system that does not provide basic diagnostics and treatment. They must also contend with a government programme that is geared to reducing the numbers any which way.
*Patients with less than five skin lesions OR only one nerve involvement have paucibacillary (PB) leprosy. Those with more than five skin lesion OR more than one nerve involvement OR who are smear positive have multi bacillary (MB) disease. A bacillary count will give further information on how infectious the disease is. Treatment for PB leprosy consists of two drugs for six months. MB is treated with three drugs for 12 months (earlier 24 months).
InfoChange News & Features, February 2009