Leprosy elimination—a virtual phenomenon or a reality?
BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7352.1516 (Published 22 June 2002) Cite this as: BMJ 2002;324:1516All rapid responses
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Since Lockwood published her article “Leprosy elimination—a virtual
phenomenon or a reality?” (1) in British Medical Journal (BMJ), a number
comments on this paper have appeared on BMJ’s website, www.bmj.com,
demonstrating concern for the future of leprosy elimination. Among the
electronic letters were comments from Daumerie (2), a responsible officer
in the Leprosy Group of the World Health Organization (WHO), and from Becx
-Bleumink (3), chairperson of the WHO Technical Advisory Group on
Elimination of Leprosy (TAG); however, neither responded to Lockwood’s
question: "why are evidence based policies not guiding the World Health
Organization’s leprosy elimination campaign?" I wish to comment on Becx-
Bleumink’s letter, in which certain technical issues need to be clarified.
1. Quality of diagnosis after integration of leprosy control into the
general health services
Although Becx-Bleumink implies (3) that opposition exists to the
policy of integration, many responsible workers strongly favour this
policy, and agree that integration is the only way to guarantee the
sustainability of leprosy control (4). On the other hand, agreement does
not exclude expression of concerns about the process of integration.
Indeed, integration is not a magic word; the process must proceed step-by-
step (4). Unfortunately, integration has been inadequately prepared in a
number of leprosy endemic countries: the vertical programme has been
dismantled, whereas the general health service is not yet ready to assume
full responsibility for essential activities of leprosy control. As a
result, the quality of service, especially that of diagnosis and
treatment, has deteriorated. Because of inadequate training, many general
health workers do not yet possess the skills required for diagnosing
leprosy; in addition, discontinuation of skin-smear services in the field
has further increased the difficulty of diagnosing certain MB patients,
particularly those close to the lepromatous end of the spectrum. As a
consequence, under-diagnosis has become a ubiquitous phenomenon. Under-
diagnosis is a topic that has been grossly neglected; because it is more
difficult to quantify than over-diagnosis, its magnitude has not been well
documented, but it probably accounts for no fewer than 30% of all
patients. One cannot simply deny its existence, and claim that the
phenomenon “is certainly not supported by evidence” (3).
2. A single criterion for diagnosing leprosy
With respect to diagnosis, the principal issues are the sensitivity
and specificity of the single sign—skin patch or patches with a definite
loss of sensation (5)—for the diagnosis of leprosy. Becx-Bleumink
estimates that “in less than 10% (of patients) the diagnosis is not easy”
(3). However, based on published data from ALERT, in which Becx-Bleumink
was involved, only 70% of a cohort of patients would be detected employing
anaesthetic skin patches as the single diagnostic criterion, three-fourths
of those whose lesions were not anaesthetic and would not have been
diagnosed by the single criterion were smear-positive multibacillary (MB)
(6). Obviously, such a degree of sensitivity of diagnosis is unacceptable.
To improve the quality of diagnosis, especially to detect the great
majority of skin-smear positive MB patients, other cardinal signs, such as
enlargement of peripheral nerves and the presence of acid-fast bacilli in
skin smear, must also be employed in the field (4).
3. Skin-smear examination
For several decades, the skin smear was the only laboratory technique
widely applied in the field for the diagnosis of leprosy. If positive, it
represents direct proof for the diagnosis of MB leprosy and MB relapse,
and distinguishes MB from PB leprosy. Unfortunately, its application in
the field was recently discontinued, a decision justified by the statement
that “unnecessary skin piercing procedures are unethical” (7).
The skin smear is certainly not an ideal diagnostic technique. Its
major drawbacks, such as poor quality and potential danger of transmitting
HIV, have been correctly pointed out by WHO (7) and by Becx-Bleumink (4).
However, these are basically operational difficulties, and should not be
confused as technical justifications to discontinue the application of
skin smear in the field. The operational problems can mostly be solved by
operational approaches: for example, the quality of the examination can be
improved by better training and supervision and by upgrading the service
with necessary equipments and materials; safety can be improved by the use
of disposable materials, especially scalpel blades.
The strategy of directly observed treatment short-course (DOTS) has
been widely adopted in the recent efforts to control tuberculosis (TB)
(8). Because microscopic examination of sputum for case detection and for
assessing treatment outcome is one of the essential elements of DOTS
strategy, microscopic examination is now available rather widely in the
great majority of TB control programmes. Because many TB-endemic countries
are also leprosy-endemic, the two programmes are often closely associated
and even combined; in fact, in some countries, TB control was developed on
the infrastructure for leprosy control, as in Sulawesi (9). If sputum
samples of TB patients are examined at regular intervals by microscopy
centres, it is unimaginable that the same facilities cannot also be
applied to skin smears from leprosy patients. Of course, the technique for
taking a skin smear is different from obtaining a sputum sample,
additional training should be provided to health workers at the microscopy
centre; there is no reason to believe that, after certain training and
practice, most laboratory technicians could not take adequate skin smears.
4. Accompanied MDT: more questions than answers
Patient compliance or adherence is one of the key requirements for
successful treatment. However, non-compliance of TB (10-12) and leprosy
patients (13-15) with self-administration of treatment is a widespread
phenomenon. A review of the results of urine testing (16,17) carried out
in a number of leprosy training centres concluded that only about half of
the prescribed dapsone was actually ingested (13). Studies also revealed
that mere attendance at the clinic or collecting drugs by leprosy or TB
patients was not a reliable indicator of regular drug self-administration
(10,18). Although Becx-Bleumink reported better compliance of
paucibacillary (PB) patients with MDT than with dapsone monotherapy (19),
only 70% (18) to 80% (19) of patients were found in compliance with self-
administration of the daily component of MDT regimens when the monthly
component was administered under supervision.
To deal with the problem of non-compliance of leprosy patients with
self-administered treatment, one of the principles of the multidrug
therapy (MDT) regimens recommended by a WHO Study Group was that the
monthly component of the regimens--rifampicin alone for PB leprosy and
rifampicin plus a large supplementary dose of clofazimine for MB leprosy--
should be administered under the supervision of a health worker (20). It
was felt that supervision of the daily components of the MDT regimens was
not feasible. A decade later, DOTS strategy was introduced for TB control.
One of the essential elements of DOTS strategy is directly observed
treatment (DOT)--”watching patients taking their medications at least
during the intensive phase of treatment (the first two months) to ensure
that the drugs are taken in the right combinations and for the appropriate
duration” (21).
Implementation of supervised therapy in the field is certainly not
easy, especially in areas in which the health infrastructure is weak.
Because DOTS strategy requires TB patients to swallow each daily dose of
treatment under supervision, at least during the first two months, whereas
for leprosy patients only the monthly component of MDT regimen should be
administered under supervision, supervised therapy in TB programmes is far
more demanding operationally for both patients and health services than
that in leprosy programmes. Nonetheless, despite the fact that both WHO's
leprosy (7) and TB (8) programmes attempt to improve the accessibility of
patients to treatment, their current attitudes toward supervised therapy
differ fundamentally. Whereas the TB programme continues to recommend DOT
(8), the leprosy programme and its TAG have concluded that supervision of
monthly component of MDT regimens is not essential, and large-scale
implementation of “accompanied MDT” (AMDT) is recommended (22); and “with
accompanied MDT, patient receives a full course of MDT at the time of
diagnosis “ (5, 7)--i.e., 6 months of medication for the PB patient and 12
months for the MB patient. Some members of TAG even believe that monthly
supervision “hampers integration and is not user-friendly", and that
"providing patients with a full course of treatment on their first visit
is both patient- and staff-friendly and will improve compliance" (22).
The recommendation to discontinue supervision of monthly drug
administration appears to be a quick and simple solution to the difficult
problem of implementing supervised therapy, but the solution is obviously
wrong. Not only have WHO and TAG confused the operational difficulties of
implementing supervised therapy with the technical justifications for
discontinuing its application, and ignored completely the fact of non-
compliance of patients with self-administered medication; more
importantly, the recommendation lacks evidence-based justification.
Furthermore, the recommendation also underestimates the importance of
regular contacts between health workers and leprosy patients, which
facilitate early detection and management of various complications,
crucial for prevention of impairments.
Experience with AMDT has yet to be documented, and it is not clear
that this approach has been tested in the field. In fact, the concept of
AMDT is very vague (5, 7, 22). First, it is unclear whether AMDT is to be
applied as a routine or only in special situations. The WHO Study Group
stated clearly that only in special situations may the involvement of
community members in MDT delivery become necessary (20). Second, it is
also unclear who may be chosen to accompany the patients and what are the
requirements. The only description available is “someone close to or
important to the patient” (7), who could be a community member or a family
member; it is unclear whether there is an order of preference. A number of
TB experts believe that supervision by a family member is less reliable
and even ineffective (23-25), and some national TB programmes, such as
that in India, have stated clearly that the DOT supervisor should be
someone outside the family (24). Third, how the AMDT “help” the patients
to complete a full course of treatment is unclear; are they expected to
observe the patients swallow each monthly dose? In some TB programmes, a
DOT supervisor who simply accompanies the patient, without literally
watching him/her swallow the drugs, was considered “actual non-DOT” (25).
Finally, training and supervising community members by health workers have
been shown to be critically important for the success of DOT for TB
treatment (26), but it is unclear how to train and supervise the AMDT?
Although a number of important questions about AMDT remain to be
answered, its large-scale implementation was one of the major
recommendations of the Global Alliance for Elimination of Leprosy (GAEL)
and TAG at their recent meetings (22). Because AMDT was recommended by
such influential institutions, it has been rapidly and intensively
implemented in the field. In an increasing number of national programmes,
the total quantity of MDT blister packs is routinely provided at the time
of diagnosis to all patients, including those living rather close to
treatment centres, the AMDT either does not exist or lacks training and
supervision. Consequently, one cannot be certain that MDT is indeed self-
administered by the patients. Can so reckless a policy be termed “patient-
and staff-friendly”?
In defence of AMDT, Becx-Bleumink cited (3) her very successful
experience of DOT in Sulawesi, which reported a high cure rate in smear-
positive TB patients (9). In that study, daily drug administration was
supervised by trained and supervised community members, and 75% of the
patients were supervised by a household member. However, all patients
attended a health centre once weekly during the first 2 months, and once
every 2 weeks during the last 4 months of treatment. Moreover, at each
visit, patients swallowed their drugs under the supervision of the health
centre staff–i.e., all patients did receive direct supervision by a health
worker at least four times more frequently during the initial phase and
two times more frequently during the continuation phase of TB treatment
than was monthly supervision of MDT recommended by the WHO Study Group
(20). Therefore, the Sulawesi experience is quite different from what
actually occurs in areas in which AMDT policy is being implemented.
5. A uniform MDT regimen for all leprosy patients
One of the most controversial recommendations by TAG is
“implementation of a uniform six-months MB/MDT regimen for all patients”
(22); WHO has clearly expressed its intention to “assist countries willing
to implement this strategy” (22). The primary reason for this controversy
is that, among MB patients treated with MDT for 12 months, there exists no
information regarding the 5-year relapse rate, a key parameter in
assessing the long-term efficacy of MDT. Without this information, how can
we justify further shortening the duration of MDT for MB leprosy? It is
indeed reassuring to learn that TAG intends only to test the uniform
regimen, and has “no intention to recommend routine implementation of this
regimen under routine field condition”(3). However, to prevent
surreptitious implementation of a uniform regimen in the field, WHO and
TAG should clarify their recommendation.
In conclusion, the quality of diagnosis and treatment of leprosy are
matters of real concern. Without a guarantee of quality, quantitative
achievements and a declaration that leprosy has been eliminated are
meaningless. To avoid building the leprosy elimination monument on sand,
we should not stick our heads in the sand and think only of the short
term. All efforts should be made to maintain and improve the basic quality
of diagnosis and treatment in the field; these tasks are as important as
increasing accessibility of MDT treatment to the patients.
Dr Baohong Ji was the secretary of “Chemotherapy of Leprosy” (THELEP)
Steering Committee of the WHO/TDR Programme between 1984 and 1989, and is
currently professor of microbiology at Faculté de Médecine Pitié-
Salpêtrière, Paris, France.
References
1. Lockwood DNJ. Leprosy elimination—a virtual phenomenon or a
reality? Br Med J 2002; 324: 1516-1518.
2. Daumerie DP. Elimination of leprosy is a reality in many
countries. Electronic letter published at www.bmj.com on 27 June 2002.
3. Becx-Bleumink M. Leprosy elimination, realities and challenges.
Electronic letter published at www.bmj.com on 28 June 2002.
4. International Leprosy Association. Report of the International
Leprosy Association Technical Forum. Indian J Leprosy 2002; 74 (Suppl): S1
-S93.
5. World Health Organization. Guide to eliminate leprosy as a public
health problem. First edition 2000. World Health Organization, Geneva.
6. Saunderson P, Groenen G. Which physical signs help most in the
diagnosis of leprosy? A proposal based on experience in the AMFES project,
ALERT, Ethiopia. Lepr Rev 2000; 71: 34-42.
7. World Health Organization. The final push strategy to eliminate
leprosy as a public health problem. Questions & answers. First edition
2002. World Health Organization, Geneva.
8. World Health Organization. An expanded DOTS framework for
effective tuberculosis control. WHO/CDS/TB/2002.297. World Health
Organization, Geneva 2002.
9. Becx-Bleumink M, Djamaluddin S, Loprang F, de Soldenhoff R, Wibowo
H, Aryono M. High cure rates in smear-positive tuberculosis patients using
ambulatory treatment with once-weekly supervision during the intensive
phase in Sulawesi, Republic of Indonesia. Int J Tuberc Lung Dis 1999; 3:
1066-1072.
10. Fox W. Problem of self-administration of drugs, with particular
reference to pulmonary tuberculosis. Tubercle 1958; 39: 269-274.
11. Fox W. Self administration of medicaments. A review of published
work and a study of the problems. Bull Int Union Tuberc 1961; 31: 307-331.
12. Fox W. Ambulatory chemotherapy in a developing country: clinical
and epidemiological studies. Adv. Tuberc Res 1963; 12: 28-149.
13. Ellard GA. Drug compliance in the treatment of leprosy. Lepr Rev
1981; 52: 201-213.
14. Huikeshoven H. Patient compliance with dapsone administration in
leprosy. Internat J Lepr 1981; 49: 228-258.
15. Huikeshoven H. Patient compliance in leprosy control: a necessity
in old and new regimens. Internat J Lepr 1985; 53: 474-480.
16. Ellard GA, Gammon PT, Helmy HS, Rees RJW. Urine tests to monitor
the self-administration of dapsone by leprosy patients. Amer J Trop Med
Hyg 1974; 23: 464-470.
17. Ellard GA, Gammon PT, Harris JM. The application of urine tests
to monitor the regularity of dapsone self-administration. Lepr Rev 1974;
45: 224-234.
18. Ellard GA, Pannikar VK, Jesudasan K, Christian M. Clofazimine and
dapsone compliance in leprosy. Lepr Rev 1988; 59: 205-213.
19. Becx-Bleumink M. Duration of multidrug therapy in paucibacillary
leprosy patients; experience in leprosy control programme of the All
Africa Leprosy and Rehabilitation Training Centre (ALERT) in Ethiopia. Int
J Lepr 1992; 60: 436-444.
20. WHO Study Group. Chemotherapy of leprosy for control programmes.
Technical Report Series 675. World Health Organization, Geneva, 1982.
21. World Health Organization. What is DOTS? A guide to understanding
the WHO-recommended TB control strategy knows as DOTS. WHO/CDS/TB/99.270.
World Health Organization, Geneva, 1999.
22. World Health Organization. Report on third meeting of the WHO
Technical Advisory Group on Elimination of Leprosy.
WHO/CDS/CPE/CEE/2002.29.
23. Frieden T, Sbarbaro JA. The slippery slope to sloppy DOTS. Int J
Tuberc Lung Dis 2002; 6: 371-372.
24. Khatri GR, Frieden TR. Rapid DOTS expansion in India. Bulletin
W.H.O. 2002; 80: 457-463.
25. Pungrassami P, Johnsen SP, Chongsuvivatwong V, Olsen J, Sorensen
HAT. Practice of directly observed treatment (DOT) for tuberculosis in
southern Thailand: comparison between different types of DOT observers.
Int J Tuberc Lung Dis 2002; 6: 389-395.
26. Volmink J, Matchaba P, Garner P. Directly observed therapy and
treatment adharence. Lancet 2000; 355: 1345-1350.
Competing interests: No competing interests
Re: "there is evidence that important policies proposed by WHO in the
field of leprosy may cause damage to many patients"
Sir,
I refer to the paper of Diana NJ Lockwood "Leprosy elimination -a
virtual phenomenon or a reality?" BMJ 2002; 324: 1516-1518 and to the
electronic responses by Dr Chandrakant R. Revankar (25 June 2002), Denis
P. Daumerie (27 June 2002) and Marijke Becx-Bleumink (28 June 2002).
I note that none of these three responses really tackle the main
aspect of the discussion: "there is evidence that important policies
proposed by WHO in the field of leprosy may cause damage to many
patients". The policies I refer to are the inadequate interest for nerve
damage prevention, the so-called "accompanied" multi-drug therapy, the
identical six month treatment regimen for pauci and multibacillary
patients, the abandon of interest for skin smear examination. These
policies are expressed in WHO documents like The Final Push Strategy to
Eliminate Leprosy as a Public Health Problem: Questions and Answers (2001)
and the WHO Technical Advisory Group (TAG) on Elimination of Leprosy
Report (2002).
1. Inadequate interest for nerve damage prevention.
Disabilities in leprosy are caused by nerve damage. TAG recommendations
and the "Final push" do not pay enough attention to this fact. The
consequences will be that several patients managed accordingly will
develop serious sequelae on their eyes, faces, hands and feet. For these
patients it would be like going twenty years back in the history of
leprosy management.
2. The so-called "accompanied" MDT.
The proposed "Accompanied" MDT regimen is puzzling. It apparently refers
to good principles like the ones that patients should be treated as close
as possible to their homes and, to flexibility in treatment distribution.
But it may merely consist in supplying six or twelve months of treatment
to the patients at the moment of diagnosis. There is same rationale in
this, but very little indeed. As a matter of fact the regimen is not
"accompanied" and we might see the patients coming back only after a long
series of deformities, from lagophthalmos to claw hands and plantar
ulcers, has taken place.
3. The identical six month treatment regimen.
TAG proposed six month multibacillary regimen for multibacillary and
paucibacillary patients will administer clofazimine to patients that do
not need this drug. It will also not administer the same drug for enough
time to those who need it. Here I would be grateful to Drs Daumerie and
Becx-Bleumink if they may say something about the mentioned multi-centre
study, might it prove the utility of clofazimine for PB patients?
4. Abandon of interest for skin smear examination.
If the quality of smears and microscopy is poor the correct answer to this
is to improve it. Here it seems that the poor quality has been used as an
excuse to adopt a particular point of view or policy. Lack of knowledge
about the bacterial load can also cause damage to patients, like the other
three points above mentioned; but it is important to say that the first
point, "Inadequate interest for nerve damage prevention", is what matters
most.
Dr Salvatore Noto
Cefpas - Centre for Training and Research in Public Health
Via G. Mulé, 1
93100 Caltanissetta, Italy.
Competing interests: No competing interests
In leprosy elimination, is the population more important than the
individual?
Editor - I would like to add to Dr Lockwood's perspective on the
World Health Organisation's (WHO) leprosy elimination campaign (1). WHO
has the unenviable task of addressing the needs of 'everyone' and taking
this perspective into consideration when creating its international
disease control policies. Within the international domain of infectious
disease control, the themes of 'eradication' (2) and 'magic bullets' (3)
continue to dominate policy perspectives. However, as is now being
witnessed by the leprosy community, there are downsides to this particular
perspective.
The philosophical underpinnings of current international public
health practice are important here. Within public health, a dichotomy is
often created between the individual and the population but there is a
danger that this dichotomy becomes polarised into support of the
population over the individual rather than support of the individual
within the population. The western philosophical perspective of
utilitarianism, providing happiness for the maximum number of people,
supports this perspective. But, 'utilitarianism ignores the separateness
of persons, and is prepared illegitimately to sacrifice the interests of
any given person with the aim, not just of protecting, but even of
increasing the aggregate welfare' (4).
Through encouraging partnerships (5) and collaborations with other
organisations like NGOs, whose role allows them to concentrate on the
individual leprosy patient, WHO is able to redress this imbalance. In the
case of international leprosy policy, a focus on the creation of
partnerships to address all those with leprosy and not simply the
majority, continues to be needed to deal with the current conflicts being
reported from the international leprosy community (1). As the Global
Alliance to Eliminate Leprosy (GAEL) has demonstrated, partnerships are
difficult and often involve different opinions and perspectives that can
lead to severe tensions and conflicts. How these tensions are dealt with
is a measure of the overall 'health' of the partnership and of the
international community as a whole.
WHO need to be encouraged to create partnerships with NGOs and other
organisations, in order to assure linkage of 'the population' with 'the
individual' and to ensure that the international community is dealing
appropriately with the concept of 'life after leprosy elimination'. It
needs to be made clear that future leprosy patients will not be abandoned
to the international goal of 'disease elimination'.
John DH Porter, Reader in International health
Departments of Infectious and Tropical Diseases and Public Health and
Policy, London School of Hygiene and Tropical Medicine, Keppel Street,
London WC1E 7HT
John.Porter@lshtm.ac.uk
References
1) Lockwood DNJ. Leprosy elimination - a virtual phenomenon or a
reality? BMJ 2002; 324: 1516-8.
2) Henderson DA. The siren song of eradication. Journal of the Royal
College of Physicians of London 1998; 32(6): 580-4.
3) Porter JDH, Ogden JA, Pronyk P. Infectious disease policy: towards
the production of health. Health Policy and Planning 1999; 14(4): 322-328.
4) Williams B. Ethics. In: Philosophy - a guide through the subject.
Editor AC Grayling. Oxford University Press 1995. Oxford.
5) Buse K, Walt G. Global public-private partnerships: Part 1 - a new
development in health? Bulletin of the World Health Organisation 2000; 78:
549-561.
Competing interests: No competing interests
The limitations of defining leprosy elimination based on the number
of patients registered for anti-leprosy chemotherapy are very well known.
The fall in number of registered patients is largely attributable to
cleaning of registers of patients who no longer need anti-leprosy
chemotherapy and to shortening the duration of the treatment. Based on
internationally accepted definitions, people affected by leprosy who have
completed a full course of treatment but still need anti-reaction
management and/or care for their disabilities are not included in the
prevalence. This does not mean that these patients should not be taken
care of. Leprosy reactions can occur before diagnosis and treatment,
during treatment and after release from treatment. Several studies have
shown that reactions can occur several years after patients have been
released from treatment (1-3). Therefore, it is crucial that patients
clearly understand that they must report back immediately if they observe
symptoms that could be caused by a reaction. This information should be
given to all patients at the time of their release from treatment,
irrespective of the duration of treatment, in simple terms in their local
language.
The paper correctly states that the number of newly registered cased
did not fall between 1985 and 1999 in the 27 top countries where leprosy
is endemic. Further, in the six top countries the number of newly
registered cases appears to be increasing. However, there is no evidence
that an increase in the number of newly registered patients reflects an
increase in incidence. In most of these countries leprosy elimination
campaigns have been carried out, including community awareness programmes,
increasing the coverage of MDT services. It is well established that
active case-detection campaigns lead to an increase in the number of
detected cases, including early, often self-healing, cases as well as over
-diagnosis of patients and possible re-registration of old cases.
I certainly agree with evidence-based policies. The statement that
patients seen at peripheral clinics will go undiagnosed is certainly not
supported by evidence. Health sector reform, including integration and
decentralization, is reality in leprosy endemic countries and should be
viewed as an opportunity. Already in the 1988 Technical Report of the WHO
Expert Committee on Leprosy (chapter 8.3, pages 42-43) (4), integration of
leprosy into the general health services, delivered through multipurpose,
decentralized health services, was promoted as the policy for optimal
health care including that for leprosy patients. I am not aware of strong
arguments against integration and results of studies that prove that in
integrated services more patients will remain undiagnosed compared to
vertical services. Evidence from Brazil, Sri Lanka and India reveals that
integration improves patients’ access to treatment and lead to an increase
in case load. A vertical approach to leprosy limits coverage and reach of
leprosy services.
I do not agree with the statement that leprosy is not an easy disease
to diagnose. It is my experience that the diagnosis can be made correctly
by trained general health staff in the majority of patients. For a small
proportion, my estimate is less than 10%, the diagnosis is not easy.
Therefore, specialized elements at defined levels are still required.
Skin smear examination may indeed be an important measure for
identification of patients with high bacterial loads. In my experience the
division of patients according to number of skin lesions is reliable in
the sense that only very few MB patients are incorrectly classified as PB.
In a study at ALERT over 92% of MB patients had more than 5 skin lesions
(5). With the high prevalence of HIV/AIDS and hepatitis in many endemic
countries, skin smear taking is considered no longer safe from a public
health perspective. When routine skin smear examination of all (suspect)
leprosy patients was the recommended international policy, there have been
several publications of the poor quality of skin smear techniques. The
quality of smears and of microscopy was identified as probably the weakest
link in most leprosy control programmes (6-10).
Although in the study referred to there was evidence that patients
with a high bacterial loads are at greater risk of relapse, this was not
observed in another study (11).
Accompanied MDT is only a new concept as far as the name is
concerned. In the 1982 Report of a WHO Study Group on “ Chemotherapy of
control programmes”, (chapter 4.3, pages 28-29) “ Complementary systems of
drug delivery through community health workers, schoolteachers, village
headmen, etc in the community” was recommended as being necessary in
special situations (12). The reference to DOTS, of which Directly Observed
Treatment (DOT) during the intensive phase of treatment is one of the five
components, is relevant if there is evidence that monthly DOT is essential
to prevent the development of (multi) drug resistance. This has so far
not been proven in leprosy. In tuberculosis control DOT, delivered by
household and other community members, can give very high treatment
results (13).
Real leprosy reactions should undoubtedly be managed by steroids.
Until the late 1980’s management of reactions requiring treatment with
steroids was considered the exclusive responsibility of specialized
leprosy hospitals. When, at ALERT, Ethiopia, we developed policies to
diagnose and treat patients in the field, we faced main problems to
convince the national and international leprosy world. Gradually
management of leprosy reactions under field conditions was accepted and
the policy developed at ALERT is now implemented globally. During the last
years I have frequently observed prescription of corticosteroid treatment
to patients who do not qualify for this treatment.
The proposed uniform regimen for PB and MB patients, composed of 6
months MB MDT, will be tested for occurrence of relapses in a multi-centre
study. There is no intention to recommend routine implementation of this
regimen under routine field conditions before preliminary results have
become available.
I am not aware of evidence for the statement that integration will
increase the difficulties of doing field based research.
Elimination is certainly not eradication. There is no evidence that
governments of countries where the elimination goal has already been
reached have disbanded their leprosy control activities. Moreover
dismantling the vertical programme cannot be considered equal to
disbanding the control activities. Infectious diseases can only be
controlled sustainably if the activities are integrated into the general
health services. Integration is the only way to ensure that leprosy
control activities are maintained for many years after the elimination
goal has been reached. The challenge will be to maintain high coverage and
quality in a cost-effective manner.
The lessons learnt from the experience of vertical tuberculosis
control programmes in the past are obvious. Since the development of the
DOTS strategy, during the 1980’s, there is no question about maintaining
vertical programmes.
Let us focus on the challenges of to-day to finally achieve a World
Without Leprosy
Dr. Marijke Becx-Bleumink has worked for over 25 years in leprosy
and/or tuberculosis control and is presently the chairperson of the WHO
Teachnical Advisory Group (TAG) on Elimination of Leprosy.
References
1. Boerrigter G., Ponninghaus J.M, Fine P.E.M. Preliminary appraisal
of a WHO-recommended multiple drug regimen in paucibacillary leprosy
patients in Malawi. Int.J.Lep. 56 (1988), 408-417.
2. Becx-Bleumink M., Berhe D. Occurrence of reactions, their diagnosis and
management in leprosy patients treated with multidrug therapy; experience
in the leprosy control program of the All Africa Leprosy and
Rehabilitation Training Center (ALERT) in Ethiopia. Int.J.Lepr, 60 (1992),
173-174
3. Saunderson P., Gebre S., Desta K., Byass P., Lockwood D.N.J. The
pattern of leprosy-related neuropathy in the AMFES patients in Ethiopia:
definitions, incidence, risk factors and outcome. Lepr.Rev. 71 (2000), 285
-308.
4. WHO Expert Committee on Leprosy. Sixth Report. Geneva: World Health
Organization, 1988. Techn.Rep.Ser.768.
5. Becx-Bleumink M. Allocation of patients to paucibacillary or
multibacillary drug regimens for the treatment of leprosy: a comparison of
methods based mainly on skin smears as opposed to clinical methods and
alternative clinical methods for classification of patients. Int.J.Lepr 59
(1991) 292-303.
6. Georgiev G.D., McDougall A.C. Skin smears and the bacterial (BI) in
multiple drug therapy programs: an unsatisfactory and potentially
hazardous state of affairs. (Letter) Int.J.Lepr. 56 (1988), 101-103.
7. Georgiev G.D., McDougall A.C. The bacteriological examination of slit-
skin smears in leprosy control programmes using multiple drug therapy; a
plea for radical changes in current operational methodology. Indian
J.Lepr. 59 (1987), 373-386.
8. Georgiev G.D., McDougall A.C. A re-appraisal of clinical and
bacteriological criteria in the implementation of multiple drug therapy
for leprosy control programmes and proposals for their better use.
Lepr.Rev. 64 (1990), 64-72.
9. Nash J.E., Hudson B.J., Pyakaluie T. Leprosy score chart to assist
classification. (Letter) Lepr.Rev. 60 (1989), 242-243.
10. World Health Organization. Report of the third coordinating meeting on
implementation of multidrug therapy (MDT) in leprosy control programmes.
Geneva: WHO, 1988. WHO/CDS/LEP/88.4
11. Gebre S., Saunderson P, Byass P. Relapses after fixed duration
multiple drug therapy: the AMFES cohort. Lepr.Rev.71 (2000), 325-331.
12. WHO Expert Committee on Leprosy. Report of a WHO Study Group. Geneva:
World Health Organization, 1982. Techn.Rep.Ser.675.
13. Becx-Bleumink M, Sundari Djamaluddin, Loprang F, de Sodenhoff R,
Wibowo H, Aryono M. High cure rate in smear-positive tuberculosis patients
using ambulatory treatment with once weekly supervision during the
intensive phase in Sulawesi, Republic of Indonesia. Int.J.Tub.Lung Dis.
3(12) (1999), 1066-1072.
Competing interests: No competing interests
Sir,
This is in reference to the communication titled " Leprosy
elimination-a virtual phenomenon or a reality?" by Diana NJ Lockwood( BMJ
2002:324:1516- 1518(22 June 2002).
Leprosy elimination strategies are informed by field experience and
based on the success - and failure - of leprosy control work in the past
decades. This work is carried out and documented by thousands workers in
more than hundred countries, most of them having achieved the elimination
of leprosy as a public health problem.
The issues raised by Dr Lockwood are relevant. All of them along with
many others are discussed by independent expert committees and technical
advisory groups conveyed by WHO. We would like to encourage your readers
to refer to the Question and answers document that is so often quoted by
Dr Lockwood and that can be found at www.who.int/lep/faq.
We share the concerns of Dr Lockwood regarding the lack of interest
in leprosy research. However, the world faces many urgent public health
threats and it is not surprising that these attract more interest and more
resources. Specialized NGOs such as ILEP raising significant resources
(around 70 million US$ every year) from the public in order to ‘eradicate
leprosy’ (see LEPRA website http://www.lepra.org.uk), could pay a major
role in that.
For centuries, often with the best possible intentions for their own
good or that of the community, leprosy patients were turned out of their
homes and isolated in “leprosaria”. Today all persons diagnosed with
leprosy throughout the world can be treated and cured while leading a
completely normal life. Now it is a challenge of logistics and
infrastructure, of determination and dedication and not letting go until
the goal of ensuring that no further lives are devastated by this disease.
All endemic countries have decided that their efforts must focus on
integrating leprosy into the general health services. Health workers at
all levels are able to diagnose leprosy, and treatment must be made
available in all primary health centres to enable patients to be treated
as close as possible to their homes. At the same time as we are striving
to make treatment readily available, a simultaneous priority must be to
create a positive environment. Health care providers and communities now
understand that the challenge of eliminating leprosy from their homes,
schools and villages is no longer insurmountable. We must provide them
with simple information clearly communicating the message that there is no
need to be afraid of leprosy that it can be cured and treatment is
available free.
Possible competing interest: the writer is employed by the World
Health Organization, Leprosy elimination programme
Competing interests: No competing interests
Sir,
This has reference to the communication titled " Leprosy elimination-a
virtual phenomenon or a reality?" by Diana NJ Lockwood( BMJ 2002:324:1516-
1518(22 June) questioning the evidence for WHO's Leprosy Elimination
Campaign.I as a Public Health Physician and Leprologist working in the
field of leprosy since 1974, would like to put my views before the
readers.
1.A bold decision on the part of WHO to implement MDT without waiting
for long term field trials led to the formulation of the elimination
concept and setting the target date for the leprosy elimination as a
public health problem as agreed by the member states at the World Health
Assembly in 1991. This has really built up the political committment and
energized the programme managers at governments and NGOs level, without
which, we would not have not been able to bring down the global case load
from 10-12 million to 0.59 million by the end of 2001. WHO and several
other partners (ILEP, Bilateral agencies, World Bank and local NGOs) have
played a very significant role in curing more than 11 million patients
and reducing the severity of the transmission of the disease in the
community and disability rate among the new cases.
2. Considering the magnitude of the problem, rightly, the programme has to
accord priority to control of the communicable part (transmission) of the
disease. Indirectly, this also reduced the disability rate among the new
cases wherever intensive and sustained case finding activities are being
practised.100% geographic and patient coverage is essential to achieve
leprosy elimination in a realistic sense. We will be constantly haunted
by these backlog cases (specially skin smear positive and multiple
lesions) without intensifying case detection by any methods suitable to
rural and urban situations.
WHO recommended Leprosy Elimination Campaigns(LECs ) in endemic countries
such as India,Brazil,Myanmar,Madagascar,Nepal and Mozambique have helped
to rapidly indetify as many back log cases as possible within a short
time and bring them under MDT. This accelerated activity has rapidly
increased the new case detection. This apparent increase has been
mistaken for rise in the incidence rates. Such thrust to case detection
activities at regular intervals by the programmes may ultimately reduce
new case detection rate. It is observed that there is no impact on true
incidence rate.The intensive leprosy control work by Bombay Leprosy
Project in a group of slums ( incuding Dharavi with a population of 4
million) in Bombay over a period of 25 years gave evidence to show
that MDT is bringdown the transmission. A low level of transmission is
maintained mainly by migrant leprosy patients( more than 60% in Bombay),
an urban phenomena, the programme managers have to face. The role of MB
relapses also should be considered for maintaining low level of
transmission.
3. By understanding immunity, microbial behaviour and actions of
chemotherapeutic agents, we have learnt to treat leprosy patients with
optimum drug combination for a optimum duration suitable for a mass
programme even in a most difficult situation.Individual
doctor(dermatologist) may divert from the standard guidelines. High
relapse rates in patients with more than 3 + BI have been reported by
JALMA-AGRA and Jamet et al from Bamako Mali. Other groups Lee et al from
China and Bombay Leprosy Project from India have not made such
observations in high BI patients. We may have to think of certain
geographic peculiarities or impact of previous treatment with dapsone.
4. No doubt, we are left with a backlog of 2-3 million cured leprosy
patients with disabilities who will be needing care. Even after the polio
eradication, we will be left with disabled polio victims who will be
needing care.
4. Leprosy elimination does not bring an end to the site. It is a
beginning of our march towards eradication of the disease (zero
transmission) and overcoming all the issues related to leprosy patients at
large. Sustained efforts and resources will have to be continued till we
achieve a "World Without Leprosy" a concept propagated during the
International Leprosy Congress, Beijing,1998.
Several issues such as continued transmission of the disease at a low
level, Prevention of Disabilities, management of reactions, relapses,
patient dissatisfaction for clinically visible skin lesions after short
duration MDT/ROM, rifampicin resistance,socio-economic rehabilitation and
integration will have to be taken care.
4. In view of fast emerging other communicable diseases with very
high mortality rate such as TB, HIV/AIDS, Malaria, there is an urgent need
to pool our resources and energy to work together to reach our targets
step by step over a period of time not only to develop simple and robust
field technologies but also care those who are in need. ILA Technical
Forum expert group which met in Paris in February 2002 has identified
crucial areas for further work.
5. In any public health programme of this magnitude, some casualties
are bound to occur.Some falacies and errors are likely occur. Let us
improve the programme day by day to improve the quality of life of leprosy
patients based on our experience and achieve our final goal of reaching a
World Without Leprosy.
Competing interests: No competing interests
Dr Lockwood should be congratulated for her excellent article which
exposes the statistical sleight of hand that underpins WHO's drive to
leprosy elimination.
As well as sharing features with the neurodegenerative disorders,
leprosy also shares some important features with tuberculosis. These
include its bacteriology, immunology (a range of host responses
determining a complex clinical spectrum), sociology (diseases of poverty,
persisting stigma), multi-drug treatment regimens and control strategies.
Tuberculosis and leprosy control programmes have much to learn from each
other.
Given these important similarities, it is surprising that WHO's
Leprosy Elimination Campaign has not learnt the lesson of meticulous
patient supervision from the Global Tuberculosis Program. Directly
Observed Treatment Short-course (DOTS) has proved valuable as a means of
achieving compliance, cure and public confidence. While a full DOT
strategy is not required for leprosy, the laissez faire strategy of
‘accompanied’ multidrug therapy is surely a recipe for disaster.
Undetected neurological sequelae, treatment failure, relapse and a loss of
public confidence will be accompanied by statistical claims of ‘treatment
success’ and leprosy ‘elimination’ at governmental level.
There are also important differences between tuberculosis and
leprosy. Highly infectious tuberculosis (sputum smear positive disease) is
the easiest to detect. The converse is true in leprosy, where highly
infectious lepromatous leprosy may show few signs obvious to the untrained
person, and so cases may remain undetected for many years. At the other
end of the spectrum paucibacillary 'tuberculous' leprosy may be easily
detected and treated but carries little if any risk to the rest of the
population. A 'simplified' leprosy programme is likely to concentrate on
the easy to diagnose non-infectious cases, and disease transmission will
continue unchecked.
Competing interests: Dr Cordell has worked in the past in a combined
tuberculosis and leprosy control programme
Competing interests: No competing interests
Leprosy eliminationa virtual phenomenon or a reality?
Editor:
Manipulation of numbers is an old game: this led Benjamin Disraeli to
make his famous aphorism “lies damned lies and (politics) statistics”.
Diana Lockwood has hit the nail on the head by her timely and important
article(1). The amount of statisticulation that is now going on in the
name of “Elimination of Leprosy” is astounding. A similar political
manipulation of statistics was resorted in re-defining poverty in India,
changing the number of k-calories required per day per individual.
Those committed to elimination of leprosy should be deeply concerned
with unconfirmed policy changes, redefinition of leprosy, excluding single
skin lesions (SSL) in both prevalence and incidence statistics, labeling
an incomplete or inadequately treated patient who still requires MDT as
”recycled” and excluding them as well. Such directives and orders aimed
at reaching “elimination” by the revised target date can only be counter-
productive. MDT is a powerful tool and has done wonders in both reducing
duration of treatment as well as encouraging large number of patients to
seek early treatment, despite stigma and opposition. Let us not overdo
the MDT strategy and turn a blind eye to the problems of continuing
transmission of leprosy, delay in seeking treatment and irrational or
inadequate treatment to those needing appropriate therapy(2). Doing away
with all laboratory confirmation, arbitrary field definitions of leprosy
can only confuse health professionals and public alike allowing leprosy
afflicted to regress into socio-medical problems which had plagued
leprosy so far.
Diana Lockwood(1) cautions about disbanding leprosy programmes and
dispersing all skilled staff; this is very real danger. However
institutions such as Schieffelin Leprosy Research and Training Centre,
Karigiri, South India are standing firm in maintaining their focus on
leprosy and will continue to nurture expertise for training, research and
management of complications. I hope the other non-governmental leprosy
organizations will do the same.
I wish all those seriously interested in leprosy would go through
this article and seek evidence-based strategies to truly reach
elimination.
References:
1) Lockwood DNJ: Leprosy Elimination a virtual phenomenon or a
reality? BMJ 2002; 324:1516-18.
2) Rao PSSS, Gift N, Rao, GS, Samuel P and Bushanam RS:
Elimination of leprosy: the integration of leprosy related activities into
the general health services of Tamilnadu. Lep Rev 2002; 73:123-129.
Competing interests: No competing interests