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RESEARCH IN LEPROSY - ( H.D.)
LEPROSY - RESEARCH AND BEYOND THE YEAR 2000
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Leprosy (Hansen’s Disease) has been one of the most dreaded of all diseases because, even though one may recover clinically, both through the body’s own self-healing immune response and/or through chemotherapy, nerve damage can result in lifelong crippling deformities. In some communities, its sufferers are the victims of intense social prejudice, discrimination and stigma. For centuries, leprosy has been shrouded in mysteries, myths and religious superstitions to the point where it has been called “The Living Death”.
Until the year 1950, when Diamino Diphenyl Sulphone (Dapsone or DDS) became available, there was no real cure for the disease. Chaulmoogra Oil / Hydnocarpus Oil or derivatives such as Sodium Hydnocarpate were the only hope the patients had of recovery. Even then, DDS, being a bacteriostatic drug, does not actually kill the leprosy bacilli but only prevents their multiplication. For many years, it did seem that Dapsone would eventually help us in eliminating leprosy, until resistant organisms began to appear. Fortunately, new and more potent drugs such as Rifampicin ( used also in treating T.B.) became available and, using this drug, in combination with other drugs (Multi Drug Therapy or MDT), has given real hope that, sometime in the future, the elimination of Hansen’s disease could possibly become a reality.
After extensive trials, in 1981, the World health Organisation (W.H.O.) recommended the use of three drugs (Dapsone, Clofazamine and Rifampicin), in a two year course, against the more infectious lepromatous or multibacilliary forms of the disease and two drugs (Dapsone and Rifampicin), in a six months course in treating the less infectious Paucibacilliary forms. This treament (MDT) has brought new hope to millions of sufferers and, combined with more efficient means of diagnosis, has resulted in the prevention of much ulceration, crippling deformities and other disabilities. In addition to this, intensive health educational programmes have resulted in the curbing of much misunderstanding, superstition and stigma.
So spectacular has been the control programmes , using MDT, that millions have been completely cured of the disease in recent years, enabling the W.H.O., in 1991, to give serious consideration to actually eliminating the disease as Smallpox has been eradicated. In 1991, the W.H.O. adopted a resolution in its International Assembly, setting the goal of -- “Eliminating Leprosy as a Public Health Problem by the year 2000”. “Elimination” was defined as attaining a level of prevalence below one case per 10,000 population in a given society. Today, almost every registered leprosy patient in the world has access to free MDT resulting in the curing, over the past 10 years, of nearly 8 million leprosy sufferers world-wide. It is true to say that this dreaded disease has been reduced by as much as 80%, thanks to the W.H.O. and the associated 20-odd non-govt. international Member Organisations of ILEP (International Federation of Anti-Leprosy Associations) .
THE CHALLENGE to face the remaining 20% of the leprosy problem must save us from a spirit of complacency. Sadly, there are many people who imagine that, by the year 2000, no cases of leprosy will exist . In actual fact, LEPROSY, WITH ALL ITS SUFFERINGS, WILL BE AROUND FOR A LONG TIME TO COME - WELL INTO THE 21st. CENTURY.
WORLD HEALTH ORGANISATION (W.H.O.) REPORT ON LEPROSY RESEARCH
While the W.H.O. is to be applauded for undertaking this enormous effort, certain concerns remain and TLM is to be commended for highlighting the following:- :-
1. MDT has not been implemented yet in all endemic areas. In some regions, because of political instability, it is virtually impossible for control teams to enter.
2. Killing bacilli (M.leprae) by chemotherapy (MDT), is only one measure of successful treatment of leprosy. Nerve damage, which, being leprosy’s hall-mark, is not reversed by MDT. Many treated patients still need rehabilitation and others suffer from the enormous psychological stigma of the disease.
3. Relapse rate may rise with time. This has been observed since the introduction of MDT. To control costs, WHO.’s MDT regimen is truncated. Early data suggests that relapse of clinical leprosy, years after completion of MDT, may become a greater problem than anticipated.
4. Although the prevalence rate of leprosy is falling as patients are enrolled on MDT, the incidence of new cases has remained constant at > 650,000 new cases per year.
5. Vertical leprosy control programs are being discontinued and integrated with primary health care programs. As dedicated field workers are declared unneeded and made redundant, they will not be available to detect new cases or relapsed disease. General public health personnel are not being adequately trained in differential diagnosis to detect the signs and symptoms of early leprosy.
6. Funding sources for leprosy research already have begun to dry up and, in the face of this prophecy, causing a serious “brain-drain” of dedicated , productive researchers with the necessary expertise.
7. While self-serving cries for the mere continuation of leprosy research must be avoided, there is a concern that we may be dismantling the very research and control measures needed to eventually, truly control leprosy around the globe, a costly mistake already made in relation to malaria and tuberculosis control efforts.
Out there in Cyberspace, are there any who feel a call to study Microbiology - to help us find the elusive anti-leprosy vaccine?
Please do not imagine that this is merely a “medical issue” . It has enormous social implications, particularly in view of the prevailing stigma, persistent misinformation and religious superstitions concerning the disease.
Please don’t think that your country or your particular race are immune to the disease. Leprosy is no respecter of persons, whatever be your creed, culture or social status. It is an insidious disease, but one that, with early detection, proper diagnosis and adequate MDT, is totally curable with all its horrendous deformities, ulcerations, blindness and disfigurement, totally preventable. Just because funds are short, there is no need for us to become complacent. Until we have that anti-leprosy vaccine and eradicated the stigma of the disease, we must remain vigilant. To gain a glimpse of what the fate of leprosy sufferers could again possibly become, because of our apathy, please read Chapter Ten (THE CHALLENGE OF LEPROSY")of :-
"AN IMPOSSIBLE DREAM"
GOOGLE INDEX OF GLOBAL LEPROSY RESEARCH BY NUMEROUS GROUPS
INDIA APPROVES LEPROSY VACCINE ( Ganapati Madur, New Delhi )
(Reproduced from the British Medical Journal, Feb. 1998 )
A vaccine against leprosy has been approved by India’s drug control agency and is to be incorporated into the national eradication programme. The vaccine is designed to be used as an adjunct to standard Multi-Drug-Therapy to accelerate healing and reduce the duration and cost of treatment.
The vaccine, developed at the National Institute of Immunology in New Delhi, is said to be the first in the world that stimulates the immune system to kill Mycobacterium leprae. The vaccine, administered intradermally, is prepared from a non-pathogenic strain of Mycobacterium, first isolated in the mid-1970’s from the sputum of a patient with tuberculosis in Madras.
“Patients who receive the vaccine and standard anti-leprosy multi-drug-therapy, show faster clinical improvement and more rapid clearance of bacteria than those who receive only drugs”, said Dr. Rama Mukherjee, a senior scientist at the institute. “Whereas multi-drug-therapy, using Rifampicin and two other drugs, takes 12 - 24 months, the vaccine will help to reduce duration of treatment by at least six months in the most severe cases”, Dr. Mukherjee said.
We expect this vaccine to provide a big boost to the leprosy eradication programmes”, said Dr. Manju Sharma, secretary of India’s department of biotechnology, which invested about 20 million rupees (approx. 300,000 pounds sterling or $480,000 ) in the project.
Leprosy is prevalent across Asia, Africa and Latin America, but India accounts for 60% of the global pool of patients with leprosy, estimated to be about one million in 1996. One fifth of patients are below the age of 18 years.
The vaccine is based on the concept of “cross reacting antigens”, in which the killed Mycobacterium strain is used used to stimulate the immune system into mounting an attack on M.leprae. “This is possible because the two bacilli have cross-matching antigens”, said Dr. Mukherjee. The first commercial batch is expected to be released by June 1998, and will be sold in India at Rupees six (10 British pence) a dose.
Health Ministry officials, however, have expressed reservations about the impact of the vaccine in the leprosy eradication programme. “We don’t see any real advantage of using this adjunct. Patients who are on standard multidrug-therapy are not expected to feel any benefit from the faster clearance of the bacteria brought about by the vaccine. Drug treatment alone does lead to complete elimination of bacteria, although the process may be slower,” said a senior official.
Others argue that the vaccine has been known to cure the disease and clear bacteria within six months in some patients. “It will also help prevent reactivation of the disease in the most severe cases”, said Gursaran Talwar, former Director of the National Institute of Immunology. India is nowhere near eradicating leprosy with the current treatment available. Last year, the health teams detected 400,000 new cases of leprosy.
Institute scientists say that the immunoprophylactic role of the vaccine is also under investigation. Over the past eight years, nearly 23,000 healthy contacts of patients have received the vaccine. The results of this study are not expected for another three years because of the long gestation period of the leprosy bacteria.
(Extract from a WHO document)
......... While no specific vaccination has yet been identified, it has been recently shown that some protection is given after a second BCG injection. However, widespread vaccination campaigns are not considered worthwhile
COMMENT ON THE NEW INDIAN VACCINE BY THE LEPROSY MISSION’s MEDICAL CONSULTANT, Dr. MICHAEL WATERS (12 March, 1998).
(Extract from TLM’s “Newslink” Issue #32, April 1998 )
“It is clearly noted that this vaccine is being introduced as an adjunct to standard Multi-Drug-Therapy (MDT), for treatment (immunotherapy) of established cases of leprosy.
Hansen was the first to attempt immunotherapy. After the introduction of Dapsone, the method fell into disuse, until 1982. Convit claimed that repeated injections of live BCG, plus dead M.leprae (the leprosy bacillus) produced clinical improvement, and a more rapid fall in the bacteriological index (B.I.) in lepromatous cases, and improved resistance (immunological status) in old, smear-negative lepromatous patients.
A number of other workers have used vaccines prepared from non-pathogenic, easily grown, related Mycobacteria (the family of bacteria to which the leprosy bacillus belongs) and recently, immunological substances produced by genetic engineering.
These studies, including those carried out using the Mycobacterium “W” - the Indian vaccine - have shown that the vaccines aid the removal of dead leprosy bacilli from the injection site, and, to a lesser extent, from further away, i.e. the B.I. falls faster. Improved patient resistance (produced by the vaccinations) is more variable, though the effect does occur certainly in some smear negative lepromatous patients.
Whether or not the vaccines kill leprosy bacilli is much less certain, and whether or not they will allow the duration of treatment to be significantly shortened, without increasing relapse rate, can only be proved by long term studies, not yet completed.
There are on-going studies which seek to identify the protective antigens of the leprosy bacillus. Once these have been identified, the genetic engineering technology is largely available, to allow a more specific “second generation” vaccine to be produced.“ (Michael Waters, 12 March, 19
Here is your opportunity to help leprosy sufferers
THE CHALLENGE OF LEPROSY
THE LEPROSY MISSION
'AN IMPOSSIBLE DREAM' (Our autobiography)
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