Dated: October 2002
VINTAGE FLOORING
Bharat Tiles offers a unique range of heritage and other designer flooring.
TEXT BY SHARDUL NAUTIYAL
Bharat Floorings and Tiles, makers of the 'Bharat', brand of cement mosaic tiles, have gained recognition for providing customised quality flooring in homes, offices and landmark buildings in India, since 1922.
HOME REVIEW PROMOTION
In The News
They offer a unique range of heritage and other designer floorings. The range of heritage floors, which resemble the old 'Minton style' of the Victorian period, are handcrafted from original moulds and processes. Moreover, their heritage floors are known for durability, having stood the test of time for the past 80 years.
They come in wide range of colours, designs, borders and motifs, allowing for high levels of choice and customisation. The company also has a range of 'mini' tiles in attractive shapes, as well as engraved tiles and borders often used in palaces and temples. Besides this, Bharat Tiles offers a premium range of "Terrazo" tiles, using marble and tessellated chips of various sizes, imported from across the world. Their 'Artdeco' range - another exclusive - offers self-coloured tiles in trendy colours and tiny chips.
The Bharat Floorings group undertakes flooring installation, renovation and restoration services. They have installed some of the best-known floors in India... in palaces of Maharajas, residences of prominent people, corporate offices, hotels, schools and public buildings. Leading corporates like Tatas and Reliance, schools like Cathedral and John Connon, public buildings like the Bombay Muncipal Corporation's headoffice, the Western Railway's headoffice and Salar Jung Museum are a few of Bharat's clientele.
They offer architects, interior designers, corporate organisations and homeowners the option of custom-designing their floors in a variety of designs.
Tuesday, December 19, 2006
Tuesday, December 12, 2006
ONCOLOGY RESEARCH
Bone marrow registry - need of the hour, say experts
Shardul Nautiyal - Mumbai
India urgently needs more bone marrow(BM) registries to ensure immediate access to matching bone marrow, for patients suffering from gentic blood disorders, suggest experts. They emphasise that public should be educated about the existence and methodology of such a set up, which would enable voluntary BM donation in the country for the expansion of current BM donor database in the world. The current BM database of 89 lakh BM donors existing in the registries across the world have a very poor representation of the Indian BM donors.
As of now, countries like Australia, Japan, France, Germany, Scandinavia, Italy, Holland, US (National Marrow Donor Program) and UK (Anthony Nolan Donor Marrow Registry) maintain big registries. The 89 lakh bone marrow database of the world is existing in the form of these registries.
A bone marrow (BM) registry is a collection of ‘voluntary healthy donors’ willing to donate their bone marrow (or stem cells) to the patient if their HLA phenotypes (or HLA profile) match cent per cent. As of now, only two bone marrow registries exist. One is at Tata Memorial Hospital, Mumbai and the other at All India Institute of Medical Sciences (AIIMS), New Delhi.
The need for the registry stems from the fact that many patients do not find a match within the family and the community. Therefore, they are left with no option but to seek BM transplant from outside. Says Dr S B Rajadhyaksha, head, department of transfusion medicine, Tata Memorial Hospital, “BM transplantation is hampered as probability of finding a donor match within a family is only 25 per cent. Many patients would have to undergo other modes of therapy or find an unrelated matched donor. Besides this government may not find the urgency for a BM registry as it has other priorities.”
According to Dr N K Mehra, head, department of transplant immunology and immunogenetics, AIIMS, a bone marrow registry is required because of the ethnic diversity of the Indian population. “We need a marrow registry in India because of the unique genetic make up of the population of India, particularly as far as the HLA diversity is concerned,” says he.
The chances of any two unrelated individuals matching are between 1 in 100 to 1 in a million depending on how frequently the individual’s antigens are found in the population. Extensive genomic studies conducted at AIIMS has revealed several “novel HLA genes” and “unique HLA haplotypes” in Indian population making a person of Indian origin at a lesser chance of finding a HLA ’full house’ matched donor and 20 per cent less chance than their Caucasian counterpart from the available pool of 8.9 million donors around the world.
Marrow transplantation is the only cure for many diseases such as leukaemia, aplastic anaemia, thalassaemia and other haematological malignancies, say experts. More than 60 potentially fatal diseases including several types of leukaemia are treated with unrelated marrow transplants. Overall survival rates for diseases that would inevitably be fatal without transplantation is 40 to 50 per cent. Marrow transplants are used to treat patients whose marrow stops producing the correct amounts of various blood cells.
To set up a bone marrow registry, one requires to have HLA testing facilities including DNA-based technologies, donor recruitment drives, a computer set up with a systems analyst, scientists, technicians and an advisory board. The cost of setting up such a registry is Rs 20-30 lakh. “It should be established in an academic institution without any commercial interests. Ministry of Health through the Indian Council of Medical Research (ICMR) should take an initiative in setting up such a registry,” says Dr Mehra.
Tata Memorial hospital is equipped with facilities which are basic to a bone marrow Registry. At AIIMS, the Asian Indian Donor Marrow Registry (AIDMR) is existing since 1994, with a current bone marrow database of 3,000 donors. This registry, which was founded by Dr Mehra as the chairman, has functional links with all other registries around the world. “As the registries across the world are networked, we want that the public in India should be educated about the need for a BM registry. Social organisations, planners, economists and medical fraternity should come forward in helping expand the registry by funding and making public aware” Dr Mehra added. Box
HLA typing is based on the concept that the genetic trait used for matching is HLA. HLA is a protein found on the surface of White Blood Cells(WBC) and other tissues. The patient’s and the donor’s HLA is matched in the process. There are HLA-A, B, C and DR antigens. Each individual has two sets of these antigens, one set inherited from each parent. For this reason, it is much more likely for a brother or sister to match the patient. It is most likely to find a matched donor within the same racial or ethnic group as well. The cost of a HLA typing ranges from Rs 3,000 to 10,000.
shardulnautiyal@rediffmail.com
Shardul Nautiyal - Mumbai
India urgently needs more bone marrow(BM) registries to ensure immediate access to matching bone marrow, for patients suffering from gentic blood disorders, suggest experts. They emphasise that public should be educated about the existence and methodology of such a set up, which would enable voluntary BM donation in the country for the expansion of current BM donor database in the world. The current BM database of 89 lakh BM donors existing in the registries across the world have a very poor representation of the Indian BM donors.
As of now, countries like Australia, Japan, France, Germany, Scandinavia, Italy, Holland, US (National Marrow Donor Program) and UK (Anthony Nolan Donor Marrow Registry) maintain big registries. The 89 lakh bone marrow database of the world is existing in the form of these registries.
A bone marrow (BM) registry is a collection of ‘voluntary healthy donors’ willing to donate their bone marrow (or stem cells) to the patient if their HLA phenotypes (or HLA profile) match cent per cent. As of now, only two bone marrow registries exist. One is at Tata Memorial Hospital, Mumbai and the other at All India Institute of Medical Sciences (AIIMS), New Delhi.
The need for the registry stems from the fact that many patients do not find a match within the family and the community. Therefore, they are left with no option but to seek BM transplant from outside. Says Dr S B Rajadhyaksha, head, department of transfusion medicine, Tata Memorial Hospital, “BM transplantation is hampered as probability of finding a donor match within a family is only 25 per cent. Many patients would have to undergo other modes of therapy or find an unrelated matched donor. Besides this government may not find the urgency for a BM registry as it has other priorities.”
According to Dr N K Mehra, head, department of transplant immunology and immunogenetics, AIIMS, a bone marrow registry is required because of the ethnic diversity of the Indian population. “We need a marrow registry in India because of the unique genetic make up of the population of India, particularly as far as the HLA diversity is concerned,” says he.
The chances of any two unrelated individuals matching are between 1 in 100 to 1 in a million depending on how frequently the individual’s antigens are found in the population. Extensive genomic studies conducted at AIIMS has revealed several “novel HLA genes” and “unique HLA haplotypes” in Indian population making a person of Indian origin at a lesser chance of finding a HLA ’full house’ matched donor and 20 per cent less chance than their Caucasian counterpart from the available pool of 8.9 million donors around the world.
Marrow transplantation is the only cure for many diseases such as leukaemia, aplastic anaemia, thalassaemia and other haematological malignancies, say experts. More than 60 potentially fatal diseases including several types of leukaemia are treated with unrelated marrow transplants. Overall survival rates for diseases that would inevitably be fatal without transplantation is 40 to 50 per cent. Marrow transplants are used to treat patients whose marrow stops producing the correct amounts of various blood cells.
To set up a bone marrow registry, one requires to have HLA testing facilities including DNA-based technologies, donor recruitment drives, a computer set up with a systems analyst, scientists, technicians and an advisory board. The cost of setting up such a registry is Rs 20-30 lakh. “It should be established in an academic institution without any commercial interests. Ministry of Health through the Indian Council of Medical Research (ICMR) should take an initiative in setting up such a registry,” says Dr Mehra.
Tata Memorial hospital is equipped with facilities which are basic to a bone marrow Registry. At AIIMS, the Asian Indian Donor Marrow Registry (AIDMR) is existing since 1994, with a current bone marrow database of 3,000 donors. This registry, which was founded by Dr Mehra as the chairman, has functional links with all other registries around the world. “As the registries across the world are networked, we want that the public in India should be educated about the need for a BM registry. Social organisations, planners, economists and medical fraternity should come forward in helping expand the registry by funding and making public aware” Dr Mehra added. Box
HLA typing is based on the concept that the genetic trait used for matching is HLA. HLA is a protein found on the surface of White Blood Cells(WBC) and other tissues. The patient’s and the donor’s HLA is matched in the process. There are HLA-A, B, C and DR antigens. Each individual has two sets of these antigens, one set inherited from each parent. For this reason, it is much more likely for a brother or sister to match the patient. It is most likely to find a matched donor within the same racial or ethnic group as well. The cost of a HLA typing ranges from Rs 3,000 to 10,000.
shardulnautiyal@rediffmail.com
RADIOLOGY
Time to adopt PET imaging by hospitals in India
Shardul Nautiyal - Mumbai
Even as Positron Emission Tomography (PET) is more accurate and efficient in delivering functional information of body organs in comparison with MRI and CT scan, experts lament the unavailability of PET cameras in hospitals across the country. As of now, India has only one dedicated PET camera at Tata Memorial Hospital and three coincidence gamma PET cameras at Hinduja Hospital, Jaslok Hospital and Bombay Hospital.
PET is a new modality where short-lived Positron Emitting isotopes (produced by a cyclotron) are used to image function and metabolic activity of different organs and disease processes. Diagnostic examination by PET are used to evaluate a variety of diseases ranging from cancer, brain-related diseases like dementia, Parkinson’s Disease, Alzheimer‘s, epilepsy, myocardial perfusion and viability etc.
Experts lament that the government has not been forthcoming in making PET cameras available in many municipal and government teaching hospitals. Lack of funds and expertise are the major constraints, rue radiologists and nuclear medicine experts. According to Dr Inder Talwar, head, radiology department, Bombay Hospital, "The high system cost and space costs are the major roadblocks in installing a PET infrastructure in a healthcare institution."
A dedicated PET camera costs around Rs five crore to Rs 10 crore, and the cost to the patient for PET scanning works out between Rs 15,000 and Rs 20,000 in private hospitals. A coincidence Gamma PET camera costs around Rs 2.5 crore to Rs 3 crore and the cost to patient is Rs 12,500. A co-incidence camera can do three scans per day, while a dedicated one can do eight scans.
"We need to have at least two dedicated PET cameras in place for a city like Mumbai. If government institution has the facility of PET, then it can be made available to the poor people," says Dr Talwar.
Says Dr Vikram Lele, chief, nuclear medicine, Jaslok Hospital, "Apart from lack of funds and expertise, there is lack of a strong lobby of doctors to pursue this further." The Society of Nuclear Medicine and Association of Nuclear Medicine Physicians of India lobbied with the government to bring down the duty on PET cameras from 40 per cent to five per cent last year, added Dr Lele.
According to Dr Shyam Kishore Shrivastava, head, department of radiation oncology, Tata Memorial Hospital, cyclotron is required in the vicinity of the PET scanner as the radioactive substance produced by the cyclotron has short half-life. A cyclotron costs another Rs 12 to Rs 15 crore. Cyclotron produces radio-pharmaceutical material to be injected into the patient for PET imaging.
All the major cities in India like Delhi, Chennai, Kolkata and Bangalore should have one cyclotron each, suggest experts. As of now, there is only one cyclotron in India at Radiation Medicine Centre at Tata Memorial Hospital. In the pipeline, are one cyclotron in Chennai and three in Delhi. However, according to Dr Lele, "Planning to install three cyclotrons for a place like Delhi is a criminal waste of money."
"Many hospitals situated in the vicinity can share the cyclotron. Cyclotron has to be placed preferably close to one of the centres having expertise in use of radioactive substance," Dr Shrivastava added.
The problem of funds-constraint can be sorted out by revenue-sharing by different hospitals, opined Dr Lele. The entire infrastructure for PET would cost around 20 crore for a city like Mumbai which could be a centrally localised place covering around 2000 square feet.
Experts suggest that the need of the hour is to create a demand for PET and that the cost for PET scanning should be borne by the insurance companies in the country to make it affordable. Says B A Krishna, chief of nuclear medicine, P D Hinduja Hospital, "Insurance companies in India should incorporate the diseases recommended for PET scanning in their policy as practiced in the West. This will be instrumental in popularising the technology among the medical fraternity and the public." Companies like GE, SIEMENS, PHILIPS AND IBA are manufacturing new PET cameras and cyclotrons.
shardulnautiyal@rediffmail.com
Shardul Nautiyal - Mumbai
Even as Positron Emission Tomography (PET) is more accurate and efficient in delivering functional information of body organs in comparison with MRI and CT scan, experts lament the unavailability of PET cameras in hospitals across the country. As of now, India has only one dedicated PET camera at Tata Memorial Hospital and three coincidence gamma PET cameras at Hinduja Hospital, Jaslok Hospital and Bombay Hospital.
PET is a new modality where short-lived Positron Emitting isotopes (produced by a cyclotron) are used to image function and metabolic activity of different organs and disease processes. Diagnostic examination by PET are used to evaluate a variety of diseases ranging from cancer, brain-related diseases like dementia, Parkinson’s Disease, Alzheimer‘s, epilepsy, myocardial perfusion and viability etc.
Experts lament that the government has not been forthcoming in making PET cameras available in many municipal and government teaching hospitals. Lack of funds and expertise are the major constraints, rue radiologists and nuclear medicine experts. According to Dr Inder Talwar, head, radiology department, Bombay Hospital, "The high system cost and space costs are the major roadblocks in installing a PET infrastructure in a healthcare institution."
A dedicated PET camera costs around Rs five crore to Rs 10 crore, and the cost to the patient for PET scanning works out between Rs 15,000 and Rs 20,000 in private hospitals. A coincidence Gamma PET camera costs around Rs 2.5 crore to Rs 3 crore and the cost to patient is Rs 12,500. A co-incidence camera can do three scans per day, while a dedicated one can do eight scans.
"We need to have at least two dedicated PET cameras in place for a city like Mumbai. If government institution has the facility of PET, then it can be made available to the poor people," says Dr Talwar.
Says Dr Vikram Lele, chief, nuclear medicine, Jaslok Hospital, "Apart from lack of funds and expertise, there is lack of a strong lobby of doctors to pursue this further." The Society of Nuclear Medicine and Association of Nuclear Medicine Physicians of India lobbied with the government to bring down the duty on PET cameras from 40 per cent to five per cent last year, added Dr Lele.
According to Dr Shyam Kishore Shrivastava, head, department of radiation oncology, Tata Memorial Hospital, cyclotron is required in the vicinity of the PET scanner as the radioactive substance produced by the cyclotron has short half-life. A cyclotron costs another Rs 12 to Rs 15 crore. Cyclotron produces radio-pharmaceutical material to be injected into the patient for PET imaging.
All the major cities in India like Delhi, Chennai, Kolkata and Bangalore should have one cyclotron each, suggest experts. As of now, there is only one cyclotron in India at Radiation Medicine Centre at Tata Memorial Hospital. In the pipeline, are one cyclotron in Chennai and three in Delhi. However, according to Dr Lele, "Planning to install three cyclotrons for a place like Delhi is a criminal waste of money."
"Many hospitals situated in the vicinity can share the cyclotron. Cyclotron has to be placed preferably close to one of the centres having expertise in use of radioactive substance," Dr Shrivastava added.
The problem of funds-constraint can be sorted out by revenue-sharing by different hospitals, opined Dr Lele. The entire infrastructure for PET would cost around 20 crore for a city like Mumbai which could be a centrally localised place covering around 2000 square feet.
Experts suggest that the need of the hour is to create a demand for PET and that the cost for PET scanning should be borne by the insurance companies in the country to make it affordable. Says B A Krishna, chief of nuclear medicine, P D Hinduja Hospital, "Insurance companies in India should incorporate the diseases recommended for PET scanning in their policy as practiced in the West. This will be instrumental in popularising the technology among the medical fraternity and the public." Companies like GE, SIEMENS, PHILIPS AND IBA are manufacturing new PET cameras and cyclotrons.
shardulnautiyal@rediffmail.com
Homing In On HMOs
Various HMO models are being explored in India. But will HMOs take off India in a big way, asks Shardul Nautiyal.
Affordable health insurance for poor urban populace is a dream that eminent physician Dr RD Lele has nurtured for years. And it may be a reality soon through his novel concept of Health Maintenance Organisations (HMOs), offering pre-paid managed care linked to life insurance on a group basis. In an HMO, a group of doctors and other medical professionals offer care to a group of people to achieve preventive, promotive and curative care for a fixed amount. To check the feasibility of such an innovative idea in India, a survey of around 15,000 families was recently conducted in Dharavi, Asia’s largest slum located in the heart of Mumbai city. The study was conducted under the aegis of Padmabhushan Dr Lele in collaboration with family physicians (FPs), NGOs, insurance experts and actuaries to launch a pilot HMO project in Mumbai. As expected, the survey found that the families have no access to pre-paid managed care, leave aside health insurance or life insurance. The survey revealed that on an average each family spends Rs 10,000 per year for medical expenses.
The findings of the Dharavi study have been sent to TTK Healthcare Services, a Bangalore-based TPA and actuary, and a Singapore -based TPA, N-TUC Income, for designing health insurance products and schemes of pre-paid managed care and also for determining premiums for group health insurance schemes.
"The scheme would be formulated keeping in mind the population of urban slums, which is below poverty line and the fact that health insurance is something which they are not aware of"
- Nitin SharmaAssistant Manager,Medical Services TTK Healthcare Services
According to Nitin Sharma, Assistant Manager, Medical Services, TTK Healthcare Services, Mumbai, “The scheme would be formulated keeping in mind the population of urban slums, which is below poverty line (BPL) and the fact that health insurance is something which they are not aware of.”
Based on the survey, a unique scheme has been proposed -- one which would offer a life insurance cover of Rs 50,000 for the bread winner of the family, medicine worth Rs 8,000 for the entire family, cover for hospitalisation, accidents, death and pre-paid managed care through a family physician for common illnesses for the entire family, and further for chronic diseases depending on the premium given by the member of the family. Besides, the family covered under the HMO will be entitled to a free annual check-up for each member of the family and three additional visits to the FP annually.
"I have ascertained the willingness of 2,500 FPs in Mumbai, who are willing to be a part of the HMO"
- Padmabhushan R D LelePioneer, HMO
The HMO project plans to constitute a network of health NGOs, social workers, hospitals, FPs, foreign and insurance companies, actuaries, TPAs, chemists, IT professionals and financial consultants. Patients with chronic disease like arthritis, chronic bronchitis and asthma, diabetes, high blood pressure, coronary artery disease will get pre-paid managed care from a group of 3,000 FPs. One FP will be responsible for the health of 500 to 1,000 families or 5,000 individuals. If needed, the FPs can refer patients to relevant specialists on the same day. Home care and rehabilitation are also part of the managed care. “I have ascertained the willingness of 2,500 FPs in Mumbai, who are willing to be a part of the HMO,” says Dr Lele.
The facilities will be offered at an annual premium of Rs 2,000. Micro-financing through banks will enable the poor family to pay in advance for a five-year cover, to be repaid by regular monthly savings deposited in their bank account. This approach is being explored in the pilot project in collaboration with banks and insurance companies.
“HMO will not only ensure the elimination of the widely-prevalent gender discrimination against females, but it will also put major emphasis on the care of the mother, the female child and adolescent girls. It will cover knowledge regarding nutrition, menstrual hygiene, sanitary napkins, prevention of iron deficiency, sex education and prevention of STD / HIV, emergency contraception, family life education, reproductive health and promotion of breast-feeding. Care of pregnant women will ensure that no baby is born with a birth weight less than 2.5 kg,” informs Dr Lele.
According to Dr Hari Prasad, CEO, Apollo Hospitals, Hyderabad, “HMO is significant when it is able to provide not only primary care, but also high-end secondary and tertiary healthcare. The HMO model should not only be designed for common illnesses, but chronic diseases like cardiac diseases also.” It is a challenging task to provide pre-paid managed care to the three million poor citizens in Dharavi, who have to pay five per cent of their earnings as subscription. Dr Lele has thought of a way through this problem. “Bringing the communities together would help form co-operatives, who can ask the bank for loans, with a small saving of as low as Rs 200. This small amount can then be utilised as premium for the group health insurance scheme. The advantage of this system is that co-operatives and banks have a collateral relation. The group, in this case, can act as a guarantor and hence there would be less chances of the scheme lapsing,” asserts Dr Lele.
Why Is HMO Required?
Why the sudden spotlight on HMO? That is because HMOs emerged first in the US as a response to curb the escalating cost of healthcare fuelled by the private insurance model. Now, HMO is creating ripples in India. It is perceived as an ideal substitute to health insurance, which is mired in low purchase, exclusion of outpatient department payment and high claims ratios. Health insurance is still a loss-making venture for insurers.
“The problems faced by health insurance companies globally indicate that indemnity health insurance in its present form has no future in India and clearly point to an urgent need for health insurance integrated with HMO and pre-paid managed care,” says Dr Lele. In India, HMOs can effectively work through co-operatives, self-help groups and health finance programmes. The usual modus operandi for these groups is to buy group insurance cover for their members from insurance companies,” says Duggal.
CSSC-WIN’s Health Initiative
Based on Dr Lele’s model, the Centre for the Study of Social Change (CSSC) has undertaken the project Women of India Network (WIN) in Mumbai for integrated human development of slumdwellers using health as an entry point. The project is running 20 clinics in the slums of Bandra, Khar and Santacruz. The clinics have been set up to address common illnesses in the form of preventive and promotive healthcare for children and women, besides immunisation and family planning programmes.
Seventeen of these clinics are funded by Switzerland-based NGO, the International Foundation for Population Development (IFPD), supported by women’s groups in Europe, while three clinics are funded by the ICICI Bank.
In this model, one clinic looks after 1,000 families. “We are trying to bring more families into the fold by empowering women through training for income generation, savings (thrift) schemes and health education. To provide healthcare to a unit of 1,000 families, we are working with the government through community-based organisations existing in the slums,” says Dr Ramesh Potdar, Hon Secretary, CSSC.
Apollo’s Co-operative HMO Model
As opposed to group insurance schemes, Family Health Plan Limited (FHPL), a part of Apollo Group of Hospitals, has implemented a co-operative-based HMO. FHPL has run Karnataka Farmers Co-operative Scheme (KFCS) for the past three years as a part of Corporate Social Responsibility. The scheme provides high-end care to the organised group sector like Farmers Societies, Sugarcane Societies, Milk Producers Unions and large Self-Help Groups (SHGs). The scheme, conceptualised, designed and administered by FHPL, covers two million farmers, in the form of co-operatives, which pay to a corpus run by a trust. The International Labour Organisation (ILO) has declared the scheme as the single-largest healthcare scheme in the world under one umbrella. The trust operates the scheme and controls the finances.
"There is a need to introduce schemes in the organised sector as this can provide health insurance to 50 per cent of Indians"
- C Chandra Sekhar Vice President, FHPL Hyderabad
“Indian healthcare system needs to devise its own HMO model, as the health insurance schemes in India can be executed successfully in the organised sector. There is, therefore, a need to leverage government machinery and introduce schemes in the organised sector as this can provide health insurance to 50 per cent of the Indian population,” says C Chandra Sekhar, Vice President, FHPL, Hyderabad.
In the FHPL HMO model in India health insurance is integrated with a healthcare institute, working with discounted tariffs for an identifiable large group of people. “The model primarily envisages large volumes of patients so that cost can be contained,” informs Chandra Sekhar.
Some Recognised Global HMO Models
Group Model: A group of physicians from various specialties, who provide medical care to a defined patient group in return for a fixed capita fee or discounted fees. The physicians also provide healthcare to different groups concurrently.
Staff Model: In this model, the physicians join the HMO as partners, where they receive a fixed payment, bonus, incentives and even share a profit. The specialists are sub-contracted so that the patients can visit the specialist, when required. The staff model is also called the ‘Closed Panel’ as patients can only consult the physicians in the panel of the said HMO.
Independent Practice Association: An organised group of healthcare providers that provide healthcare to an identifiable group of people. Providers maintain their private practices and at the same time adhere to the guidelines established by the health plan, that is why it is called as ‘IPA-HMO model’ or ‘Open-Panel Model’.
HMO Study
A study similar to Dr Lele’s study, called ‘Community Dialogue Tools’, was conducted in the district of Sangli by health NGO Society for Natal Effects on Health in Adult life (SNEHA) and United Nations International Children Emergency Fund (UNICEF) to assess access to healthcare in urban communities. Based on the study, an assessment was made to understand the healthcare needs of the community. “The study initially started with the focus on HIV-related issues, which gradually became broad-based and later on evolved to explore the need for preventive, promotive and curative care, which forms the basis of HMO in India,” explains Dr Armeida Fernandez, Honorary Founder Member, SNEHA.
Hurdles In Implementing HMOs In India
Experts fear that Indian HMOs would repeat the functioning of their counterparts in the US, which in the pursuit of controlling costs and maximising profits, often become very inflexible, thus defeating the purpose for which they were set up.
"For both insurance and HMOs to function, the medical profession and practice has to be regulated"
- Ravi DuggalConsultant, CEHAT Mumbai
Experts are also apprehensive about the difficulty which HMOs will face in running independently. “For both insurance as well as HMOs to function, the medical profession and practice has to be highly regulated. Without strong ethics, HMOs would be doomed to failure,” says Duggal.
Hurdles In Mediclaim
It is availed by only two per cent of urban population (and 0.2 per cent of total population) in India.
It excludes medical termination of pregnancy (MTP), tubectomy and costs of preventive care (like immunisation for Hepatitis B).
The spiralling rise in the claims ratio of Mediclaim policy from 94 per cent in 2002 to 140 per cent in 2004 is alarming for a country like India.
Health insurance is still insignificant though growing at over 30 per cent per annum.
Suggestions For Developing HMOs
Considering the government’s inability to increase the required financial inputs for improving rural healthcare, both preventive and curative, Public Private Partnership is the need of the hour. “Private partners may adopt primary health centres and community health centres. Groups of doctors from cities can be encouraged to migrate to rural areas to run the PHCs and CHCs. By innovative approaches such as micro-financing and micro-health insurance, we can provide them cost-effective healthcare,” avers Dr Lele. Insurance companies/TPAs can also adopt HMO models, which would in turn control the way medical care is given or accessed. “TPAs are mired in cuts and commissions which dictate the terms of the health insurance policies, which has its bearing on healthcare delivery,” an expert quips. The other side of the coin is that most TPAs are focussed on corporate clients. Therefore, if TPAs in India transform themselves into HMOs in collaboration with a network of family physicians specialists and hospitals, the expertise of TPAs can be better utilised.
shardulnautiyal@rediffmail.com
Various HMO models are being explored in India. But will HMOs take off India in a big way, asks Shardul Nautiyal.
Affordable health insurance for poor urban populace is a dream that eminent physician Dr RD Lele has nurtured for years. And it may be a reality soon through his novel concept of Health Maintenance Organisations (HMOs), offering pre-paid managed care linked to life insurance on a group basis. In an HMO, a group of doctors and other medical professionals offer care to a group of people to achieve preventive, promotive and curative care for a fixed amount. To check the feasibility of such an innovative idea in India, a survey of around 15,000 families was recently conducted in Dharavi, Asia’s largest slum located in the heart of Mumbai city. The study was conducted under the aegis of Padmabhushan Dr Lele in collaboration with family physicians (FPs), NGOs, insurance experts and actuaries to launch a pilot HMO project in Mumbai. As expected, the survey found that the families have no access to pre-paid managed care, leave aside health insurance or life insurance. The survey revealed that on an average each family spends Rs 10,000 per year for medical expenses.
The findings of the Dharavi study have been sent to TTK Healthcare Services, a Bangalore-based TPA and actuary, and a Singapore -based TPA, N-TUC Income, for designing health insurance products and schemes of pre-paid managed care and also for determining premiums for group health insurance schemes.
"The scheme would be formulated keeping in mind the population of urban slums, which is below poverty line and the fact that health insurance is something which they are not aware of"
- Nitin SharmaAssistant Manager,Medical Services TTK Healthcare Services
According to Nitin Sharma, Assistant Manager, Medical Services, TTK Healthcare Services, Mumbai, “The scheme would be formulated keeping in mind the population of urban slums, which is below poverty line (BPL) and the fact that health insurance is something which they are not aware of.”
Based on the survey, a unique scheme has been proposed -- one which would offer a life insurance cover of Rs 50,000 for the bread winner of the family, medicine worth Rs 8,000 for the entire family, cover for hospitalisation, accidents, death and pre-paid managed care through a family physician for common illnesses for the entire family, and further for chronic diseases depending on the premium given by the member of the family. Besides, the family covered under the HMO will be entitled to a free annual check-up for each member of the family and three additional visits to the FP annually.
"I have ascertained the willingness of 2,500 FPs in Mumbai, who are willing to be a part of the HMO"
- Padmabhushan R D LelePioneer, HMO
The HMO project plans to constitute a network of health NGOs, social workers, hospitals, FPs, foreign and insurance companies, actuaries, TPAs, chemists, IT professionals and financial consultants. Patients with chronic disease like arthritis, chronic bronchitis and asthma, diabetes, high blood pressure, coronary artery disease will get pre-paid managed care from a group of 3,000 FPs. One FP will be responsible for the health of 500 to 1,000 families or 5,000 individuals. If needed, the FPs can refer patients to relevant specialists on the same day. Home care and rehabilitation are also part of the managed care. “I have ascertained the willingness of 2,500 FPs in Mumbai, who are willing to be a part of the HMO,” says Dr Lele.
The facilities will be offered at an annual premium of Rs 2,000. Micro-financing through banks will enable the poor family to pay in advance for a five-year cover, to be repaid by regular monthly savings deposited in their bank account. This approach is being explored in the pilot project in collaboration with banks and insurance companies.
“HMO will not only ensure the elimination of the widely-prevalent gender discrimination against females, but it will also put major emphasis on the care of the mother, the female child and adolescent girls. It will cover knowledge regarding nutrition, menstrual hygiene, sanitary napkins, prevention of iron deficiency, sex education and prevention of STD / HIV, emergency contraception, family life education, reproductive health and promotion of breast-feeding. Care of pregnant women will ensure that no baby is born with a birth weight less than 2.5 kg,” informs Dr Lele.
According to Dr Hari Prasad, CEO, Apollo Hospitals, Hyderabad, “HMO is significant when it is able to provide not only primary care, but also high-end secondary and tertiary healthcare. The HMO model should not only be designed for common illnesses, but chronic diseases like cardiac diseases also.” It is a challenging task to provide pre-paid managed care to the three million poor citizens in Dharavi, who have to pay five per cent of their earnings as subscription. Dr Lele has thought of a way through this problem. “Bringing the communities together would help form co-operatives, who can ask the bank for loans, with a small saving of as low as Rs 200. This small amount can then be utilised as premium for the group health insurance scheme. The advantage of this system is that co-operatives and banks have a collateral relation. The group, in this case, can act as a guarantor and hence there would be less chances of the scheme lapsing,” asserts Dr Lele.
Why Is HMO Required?
Why the sudden spotlight on HMO? That is because HMOs emerged first in the US as a response to curb the escalating cost of healthcare fuelled by the private insurance model. Now, HMO is creating ripples in India. It is perceived as an ideal substitute to health insurance, which is mired in low purchase, exclusion of outpatient department payment and high claims ratios. Health insurance is still a loss-making venture for insurers.
“The problems faced by health insurance companies globally indicate that indemnity health insurance in its present form has no future in India and clearly point to an urgent need for health insurance integrated with HMO and pre-paid managed care,” says Dr Lele. In India, HMOs can effectively work through co-operatives, self-help groups and health finance programmes. The usual modus operandi for these groups is to buy group insurance cover for their members from insurance companies,” says Duggal.
CSSC-WIN’s Health Initiative
Based on Dr Lele’s model, the Centre for the Study of Social Change (CSSC) has undertaken the project Women of India Network (WIN) in Mumbai for integrated human development of slumdwellers using health as an entry point. The project is running 20 clinics in the slums of Bandra, Khar and Santacruz. The clinics have been set up to address common illnesses in the form of preventive and promotive healthcare for children and women, besides immunisation and family planning programmes.
Seventeen of these clinics are funded by Switzerland-based NGO, the International Foundation for Population Development (IFPD), supported by women’s groups in Europe, while three clinics are funded by the ICICI Bank.
In this model, one clinic looks after 1,000 families. “We are trying to bring more families into the fold by empowering women through training for income generation, savings (thrift) schemes and health education. To provide healthcare to a unit of 1,000 families, we are working with the government through community-based organisations existing in the slums,” says Dr Ramesh Potdar, Hon Secretary, CSSC.
Apollo’s Co-operative HMO Model
As opposed to group insurance schemes, Family Health Plan Limited (FHPL), a part of Apollo Group of Hospitals, has implemented a co-operative-based HMO. FHPL has run Karnataka Farmers Co-operative Scheme (KFCS) for the past three years as a part of Corporate Social Responsibility. The scheme provides high-end care to the organised group sector like Farmers Societies, Sugarcane Societies, Milk Producers Unions and large Self-Help Groups (SHGs). The scheme, conceptualised, designed and administered by FHPL, covers two million farmers, in the form of co-operatives, which pay to a corpus run by a trust. The International Labour Organisation (ILO) has declared the scheme as the single-largest healthcare scheme in the world under one umbrella. The trust operates the scheme and controls the finances.
"There is a need to introduce schemes in the organised sector as this can provide health insurance to 50 per cent of Indians"
- C Chandra Sekhar Vice President, FHPL Hyderabad
“Indian healthcare system needs to devise its own HMO model, as the health insurance schemes in India can be executed successfully in the organised sector. There is, therefore, a need to leverage government machinery and introduce schemes in the organised sector as this can provide health insurance to 50 per cent of the Indian population,” says C Chandra Sekhar, Vice President, FHPL, Hyderabad.
In the FHPL HMO model in India health insurance is integrated with a healthcare institute, working with discounted tariffs for an identifiable large group of people. “The model primarily envisages large volumes of patients so that cost can be contained,” informs Chandra Sekhar.
Some Recognised Global HMO Models
Group Model: A group of physicians from various specialties, who provide medical care to a defined patient group in return for a fixed capita fee or discounted fees. The physicians also provide healthcare to different groups concurrently.
Staff Model: In this model, the physicians join the HMO as partners, where they receive a fixed payment, bonus, incentives and even share a profit. The specialists are sub-contracted so that the patients can visit the specialist, when required. The staff model is also called the ‘Closed Panel’ as patients can only consult the physicians in the panel of the said HMO.
Independent Practice Association: An organised group of healthcare providers that provide healthcare to an identifiable group of people. Providers maintain their private practices and at the same time adhere to the guidelines established by the health plan, that is why it is called as ‘IPA-HMO model’ or ‘Open-Panel Model’.
HMO Study
A study similar to Dr Lele’s study, called ‘Community Dialogue Tools’, was conducted in the district of Sangli by health NGO Society for Natal Effects on Health in Adult life (SNEHA) and United Nations International Children Emergency Fund (UNICEF) to assess access to healthcare in urban communities. Based on the study, an assessment was made to understand the healthcare needs of the community. “The study initially started with the focus on HIV-related issues, which gradually became broad-based and later on evolved to explore the need for preventive, promotive and curative care, which forms the basis of HMO in India,” explains Dr Armeida Fernandez, Honorary Founder Member, SNEHA.
Hurdles In Implementing HMOs In India
Experts fear that Indian HMOs would repeat the functioning of their counterparts in the US, which in the pursuit of controlling costs and maximising profits, often become very inflexible, thus defeating the purpose for which they were set up.
"For both insurance and HMOs to function, the medical profession and practice has to be regulated"
- Ravi DuggalConsultant, CEHAT Mumbai
Experts are also apprehensive about the difficulty which HMOs will face in running independently. “For both insurance as well as HMOs to function, the medical profession and practice has to be highly regulated. Without strong ethics, HMOs would be doomed to failure,” says Duggal.
Hurdles In Mediclaim
It is availed by only two per cent of urban population (and 0.2 per cent of total population) in India.
It excludes medical termination of pregnancy (MTP), tubectomy and costs of preventive care (like immunisation for Hepatitis B).
The spiralling rise in the claims ratio of Mediclaim policy from 94 per cent in 2002 to 140 per cent in 2004 is alarming for a country like India.
Health insurance is still insignificant though growing at over 30 per cent per annum.
Suggestions For Developing HMOs
Considering the government’s inability to increase the required financial inputs for improving rural healthcare, both preventive and curative, Public Private Partnership is the need of the hour. “Private partners may adopt primary health centres and community health centres. Groups of doctors from cities can be encouraged to migrate to rural areas to run the PHCs and CHCs. By innovative approaches such as micro-financing and micro-health insurance, we can provide them cost-effective healthcare,” avers Dr Lele. Insurance companies/TPAs can also adopt HMO models, which would in turn control the way medical care is given or accessed. “TPAs are mired in cuts and commissions which dictate the terms of the health insurance policies, which has its bearing on healthcare delivery,” an expert quips. The other side of the coin is that most TPAs are focussed on corporate clients. Therefore, if TPAs in India transform themselves into HMOs in collaboration with a network of family physicians specialists and hospitals, the expertise of TPAs can be better utilised.
shardulnautiyal@rediffmail.com
BLOOD TRANSFUSION
Blood transfused from relatives can be fatal
Preventing Transfusion Associated Graft Versus Host Disease(TA-GVHD) through irradiation
Shardul Nautiyal - Mumbai
A man meets with an accident while crossing the road. He is immediately rushed to the hospital. He is bleeding and needs blood urgently. Finally, his son’s blood is given to the man. The man recovers after a successful operation. After three weeks, the man dies.
The doctor who operated on him investigates the cause of the death as a complication due to blood transfusion from a relative, which in this case was his son, called as Transfusion Associated Graft Versus Host Disease (TA-GVHD). TA-GVHD, as the name suggests, is the engraftment and proliferation of T-lymphocytes from the donor’s blood in transfusion recipients, leading to tissue damage and death, eventually.
Even with the advent of safer blood supply management methods and newer technologies in blood transfusion, safety in blood transfusion is under a cloud of doubt with tranfusion related complications. The mortality rate due to TA-GVHD is over 90 per cent, say experts.
Says Dr S B Rajadhyaksha, head, department of Transfusion Medicine, Tata Memorial Hospital, "Contrary to the popular belief, that relative’s blood is safest for patients, blood or blood products, especially from first degree relatives, can result in the fatal complication called TA-GVHD. The complication generally arises in immuno-suppressed patients like cancer patients and new-born babies."
Based on the symptoms following transfusion of blood or any cellular blood component, the doctors have to be made aware that TA-GVHD is one of differential diagnosis. Such cases are therefore grossly under reported. Says Dr Sunil Parekh, haematologist, Bombay hospital, "TA-GVHD is often misdiagnosed and under-reported because the primary manifestations of TA-GVHD are skin rash, fever, bone marrow depression (lowering of blood counts), diarrhoea and jaundice."
Besides this, the unavailability of gamma irradiation facility in remote parts of the country has posed a hindrance. According to Dr Rajesh B Sawant, Tata Memorial hospital, irradiation is recommended for bone marrow Transplant patient, patient’s suffering from Hodgkins disease (lymphnode cancer), transfusion to new born infants, Intrauterine transfusions, cases of congenital immuno deficiency and patients receiving HLA matched blood components. "Only anecdotal case reports of individual cases scattered all over the world are available in medical literature.", he added.
The need of the hour is therefore to educate the doctors about such a complication and to upgrade infrastructure for gamma irradiation facility in the hospitals, suggest experts.
For patients having good immunity, the chances of developing TA- GVHD is less because the blood cells called T-lymphocytes from the transfused donor blood are recognised as foreign and therefore rejected by the recipient’s immune system. In patients, whose immunity is not good, TA-GVHD develops due to the inability to reject these T-lymphocytes, which result in their proliferation, which then attack the liver, skin, gastrointestinal tract and the bone marrow. "Although a rare complication of transfusion, it can occur even in patients whose immunity is not suppressed (immuno-competent). This happens when a patient receives blood from their first degree relatives (siblings, parents or children) or second degree relatives. In these cases, the donor’s T- lymphocytes may not be rejected as the Human Leucocyte Antigen (HLA) type of the recipient is haploidentical or bears similarity with that of the donor," said Dr Rajadhyaksha.
HLA is an important blood matching parameter, which has an important role in blood transfusion. HLA type is a genetically inherited unique marker for each individual present on the lymphocytes or white blood cells(WBC). T-Lymphocyte is a category of WBC responsible for immunity. Various treatments have been tried in patients with TA-GVHD including corticoteriods, cyclosporine, methotrexate and ATG (anti-thymocyte globulin) etc. Till date, none has proved adequately successful. Therefore Gamma irradiation of the blood or blood components from the relative’s donor is the best current technology to reduce the risk of TA-GVHD to the recipients. The usual dosage is 2500-3500 rads and requires an expensive equipment that can deliver Gamma Irradiation, currently available in very few institutions in India like CMC Hospital, Vellore, All India Institute of Medical Sciences (AIIMS), New Delhi. Sanjay Gandhi Post Graduate Institute, Lucknow, Gujarat Cancer Research Institute,Ahmedabad, Tata Memorial Hospital, Mumbai, Hinduja Hospital, Mumbai, Jaslok Hospital, Mumbai, Bombay Hospital, Mumbai etc.
World Health Organisation’s (WHO) research findings from a number of countries also indicate that blood from family donors presents a greater risk to the safety of the blood supply than blood from voluntary non-remunerated donors.
shardulnautiyal@rediffmail.com
Preventing Transfusion Associated Graft Versus Host Disease(TA-GVHD) through irradiation
Shardul Nautiyal - Mumbai
A man meets with an accident while crossing the road. He is immediately rushed to the hospital. He is bleeding and needs blood urgently. Finally, his son’s blood is given to the man. The man recovers after a successful operation. After three weeks, the man dies.
The doctor who operated on him investigates the cause of the death as a complication due to blood transfusion from a relative, which in this case was his son, called as Transfusion Associated Graft Versus Host Disease (TA-GVHD). TA-GVHD, as the name suggests, is the engraftment and proliferation of T-lymphocytes from the donor’s blood in transfusion recipients, leading to tissue damage and death, eventually.
Even with the advent of safer blood supply management methods and newer technologies in blood transfusion, safety in blood transfusion is under a cloud of doubt with tranfusion related complications. The mortality rate due to TA-GVHD is over 90 per cent, say experts.
Says Dr S B Rajadhyaksha, head, department of Transfusion Medicine, Tata Memorial Hospital, "Contrary to the popular belief, that relative’s blood is safest for patients, blood or blood products, especially from first degree relatives, can result in the fatal complication called TA-GVHD. The complication generally arises in immuno-suppressed patients like cancer patients and new-born babies."
Based on the symptoms following transfusion of blood or any cellular blood component, the doctors have to be made aware that TA-GVHD is one of differential diagnosis. Such cases are therefore grossly under reported. Says Dr Sunil Parekh, haematologist, Bombay hospital, "TA-GVHD is often misdiagnosed and under-reported because the primary manifestations of TA-GVHD are skin rash, fever, bone marrow depression (lowering of blood counts), diarrhoea and jaundice."
Besides this, the unavailability of gamma irradiation facility in remote parts of the country has posed a hindrance. According to Dr Rajesh B Sawant, Tata Memorial hospital, irradiation is recommended for bone marrow Transplant patient, patient’s suffering from Hodgkins disease (lymphnode cancer), transfusion to new born infants, Intrauterine transfusions, cases of congenital immuno deficiency and patients receiving HLA matched blood components. "Only anecdotal case reports of individual cases scattered all over the world are available in medical literature.", he added.
The need of the hour is therefore to educate the doctors about such a complication and to upgrade infrastructure for gamma irradiation facility in the hospitals, suggest experts.
For patients having good immunity, the chances of developing TA- GVHD is less because the blood cells called T-lymphocytes from the transfused donor blood are recognised as foreign and therefore rejected by the recipient’s immune system. In patients, whose immunity is not good, TA-GVHD develops due to the inability to reject these T-lymphocytes, which result in their proliferation, which then attack the liver, skin, gastrointestinal tract and the bone marrow. "Although a rare complication of transfusion, it can occur even in patients whose immunity is not suppressed (immuno-competent). This happens when a patient receives blood from their first degree relatives (siblings, parents or children) or second degree relatives. In these cases, the donor’s T- lymphocytes may not be rejected as the Human Leucocyte Antigen (HLA) type of the recipient is haploidentical or bears similarity with that of the donor," said Dr Rajadhyaksha.
HLA is an important blood matching parameter, which has an important role in blood transfusion. HLA type is a genetically inherited unique marker for each individual present on the lymphocytes or white blood cells(WBC). T-Lymphocyte is a category of WBC responsible for immunity. Various treatments have been tried in patients with TA-GVHD including corticoteriods, cyclosporine, methotrexate and ATG (anti-thymocyte globulin) etc. Till date, none has proved adequately successful. Therefore Gamma irradiation of the blood or blood components from the relative’s donor is the best current technology to reduce the risk of TA-GVHD to the recipients. The usual dosage is 2500-3500 rads and requires an expensive equipment that can deliver Gamma Irradiation, currently available in very few institutions in India like CMC Hospital, Vellore, All India Institute of Medical Sciences (AIIMS), New Delhi. Sanjay Gandhi Post Graduate Institute, Lucknow, Gujarat Cancer Research Institute,Ahmedabad, Tata Memorial Hospital, Mumbai, Hinduja Hospital, Mumbai, Jaslok Hospital, Mumbai, Bombay Hospital, Mumbai etc.
World Health Organisation’s (WHO) research findings from a number of countries also indicate that blood from family donors presents a greater risk to the safety of the blood supply than blood from voluntary non-remunerated donors.
shardulnautiyal@rediffmail.com
DIABETIC FOOT TREATMENT
Neglect of diabetic foot treatment may lead to leg amputation
Shardul Nautiyal - Mumbai
Diagnosing diabetic foot has come of age from the days of detection by a tuning fork to today’s cutting edge vibration perception threshold sensitometer, heat and cold sensitometer. However, the technological advancement has failed to translate into teatment, with around one per cent of diabetics in India living under the threat of leg amputation.
The treatment of diabetic foot is marred by dearth of diabetic foot specialists, expensive treatment, lack of training centres and an unregulated market for diabetic footwear. The magnitude of the problem can also be gauged from the fact that of over three crore diabetic population in the country, 15 per cent suffer from diabetic foot problems.
A diabetic foot implies peripheral vascular disorder, peripheral neuropathy and autonomic neuropathy or a combination of these. Diabetic foot conditions develop from a combination of causes, including poor blood circulation and neuropathy.
Says Dr Jessy Thomas, diabetic foot specialist, Hiranandani Hospital, “Diabetic with a foot complication spends 53 per cent more on the treatment other than cardiac and nephrology related complications.” The treatment for diabetic foot depends upon the grade of diabetic foot, the level of intervention like oral or (intravenous) antibiotic, offloading techniques, IPD/OPD(care), surgical intervention, vascular intervention, infrastructure of the hospital and expertise. While an intermediate surgery costs around Rs 8000 to Rs 10, 000, major surgeries are as high as Rs 20,000 to Rs 25,000. The cost can soar higher in case of vascular block, where the angiography of the legs and revascularisation with angioplasty or bypass is required. Additionally, antibiotics cost Rs 3,000 to Rs 4,000 per day. “Repeated surgeries coupled with long hospital stay is also a major contributor to the expense of the treatment of diabetic foot,” informs an expert from Hiranandani Hospital.
Shortage of specialists and expensive treatment have led to leg amputations, which could have been avoided. People with diabetes are upto 40 times more likely to undergo a lower leg amputation. Herein, the role of a diabetic foot expert comes in to salvage the limb. The amputation rate can be brought to as low as three per cent if timely diabetic foot treatment is available to patients.
Says Dr T K Sahi, honorary surgeon, J J Hospital and professor, surgery, Grant Medical College, who has pioneered the treatment and management of salvaging of limbs in the end-stages of peripheral circulatory disease with or without diabetes, “Amputations can be avoided and limbs can be saved, even in the end stages of peripheral circulatory disease through surgical techniques like ‘Revascularisation by Omental Transfer’ and ‘Bilateral Simultaneous Revascularisation’.
Recognition of her work in salvaging limbs came when she was awarded the young researcher best paper award at the World Congress 2000 of the International College of Surgeons, which concluded in Suntec City at Singapore in October, 2000.
“Diabetic foot management is a highly specialised work requiring exceptional dedication as one has to deal with several issues like injury, infection, diabetes, non-healing ulcers, circulatory deficiencies and neuropathies,” adds Dr Sahi.
Why such an acute shortage of diabetic foot specialists? Dr Arun Bal, diabetic foot surgeon, Raheja Hospital, attributes the shortage to the absence of courses in podiatry in the medical curriculum at graduate or post graduate level. “Increase in diabetic foot patients is due to the lack of diabetic foot specialists at primary healthcare centres,” remarks Dr Bal.
The unavailability of diabetic foot specialists delays the diagnosis of diabetic peripheral neuropathy or diabetic foot and hence late referral to the specialty centres leads to an escalation in the cost of the treatment, point out experts. Diabetic foot experts, who are doing dedicated work are mostly self-trained. “The existing orthotists in the country, who make artificial limbs, orthopaedic shoes and belts, are not fully equipped to make the diabetic foot wear as their training is incomplete in various aspects of diabetic foot problems,” informs Dr Bal.
Amrita Institute of Medical Sciences, (AIMS), Cochin is the only institute in India offering one-year course in diabetic foot management for nurses, one-year diabetic foot surgery for surgeons and a two-year diabetic educators Course.
Simple patient education and cost-effective footwear would prevent 85 per cent of amputation. If this is not done in the future, the country will face tremendous economic loss
Dr Arun Bal
To iron out the hurdles, Dr Bal suggests simple patient education and cost-effective footwear, which would prevent 85 per cent of amputations. “If this is not done in the future, the country will face tremendous economic loss,” cautions Dr Bal. To make the treatment more affordable, there is a need to have indigenous instruments. While the cost of an indigenous sensitometer is Rs 22,000, the cost of an imported one is Rs 85,000. “Dhansai Lab, which manufacturers these equipment has been able to sell 500 to 1000 indigenous sensitometers with the support of DFSI, across the country in a year’s time,” informs Dr Bal. Even indigenous foot scanners should be made available at all the centres across the country.
According to Dr Harish Kumar, consultant endocrinologist, AIMS, Cochin, “The specialty can get a boost if manufacturing of diabetic foot wear and equipment for testing is regulated.” Diabetic Foot Society of India (DFSI) has set up a sub committee to standardise diabetic foot care in India and bring about guidelines for diabetic footwear. DFSI is also working to educate the doctors and nurses. World Diabetes Federation (WDF) is conducting a pilot project for training teams of doctors and paramedics on diabetic foot management at primary level across the country.“The solution to the problem lies in changing medical nursing, orthotist and physiotherapy curriculum. Nursing and orthotic curriculum should also incorporate chapters on diabetic foot management,” suggests Dr Bal.
Experts say that the government and private organisations should come forward in starting training courses at various levels for prevention and treatment of diabetic foot for doctors and paramedics.
Good manufacturing practices should be applied to make simple, cost effective and scientific foot wear. “Government should recognise the huge gap in therapy and academics, thus, starting a certified course in podiatry, setting up a foot clinic in all public hospitals and increasing the awareness through exhibitions, electronic and print media,” says Dr Rajiv Kovil, consultant diabetologist, Kovil Diabetes Centre.
Some of the problems of diabetic foot peculiar to our subcontinent is because people tend to walk barefoot.
“Not only do we not use footwear indoors, but a large section of our population do not use it even outdoors. Patients with severe neuropathy do not have any sensation and are unable to feel pain on injuring their feet. These injuries like cuts from sharp objects and burns from hot surfaces are likely to occur both indoor and outdoor. So once a patient has poor sensation and poor blood supply in the feet, i.e., a “high risk foot”, it is necessary to educate the patient and use appropriate footwear to prevent injuries and ulcers in the feet,” informs Dr Kovil.
shardulnautiyal@rediffmail.com
Shardul Nautiyal - Mumbai
Diagnosing diabetic foot has come of age from the days of detection by a tuning fork to today’s cutting edge vibration perception threshold sensitometer, heat and cold sensitometer. However, the technological advancement has failed to translate into teatment, with around one per cent of diabetics in India living under the threat of leg amputation.
The treatment of diabetic foot is marred by dearth of diabetic foot specialists, expensive treatment, lack of training centres and an unregulated market for diabetic footwear. The magnitude of the problem can also be gauged from the fact that of over three crore diabetic population in the country, 15 per cent suffer from diabetic foot problems.
A diabetic foot implies peripheral vascular disorder, peripheral neuropathy and autonomic neuropathy or a combination of these. Diabetic foot conditions develop from a combination of causes, including poor blood circulation and neuropathy.
Says Dr Jessy Thomas, diabetic foot specialist, Hiranandani Hospital, “Diabetic with a foot complication spends 53 per cent more on the treatment other than cardiac and nephrology related complications.” The treatment for diabetic foot depends upon the grade of diabetic foot, the level of intervention like oral or (intravenous) antibiotic, offloading techniques, IPD/OPD(care), surgical intervention, vascular intervention, infrastructure of the hospital and expertise. While an intermediate surgery costs around Rs 8000 to Rs 10, 000, major surgeries are as high as Rs 20,000 to Rs 25,000. The cost can soar higher in case of vascular block, where the angiography of the legs and revascularisation with angioplasty or bypass is required. Additionally, antibiotics cost Rs 3,000 to Rs 4,000 per day. “Repeated surgeries coupled with long hospital stay is also a major contributor to the expense of the treatment of diabetic foot,” informs an expert from Hiranandani Hospital.
Shortage of specialists and expensive treatment have led to leg amputations, which could have been avoided. People with diabetes are upto 40 times more likely to undergo a lower leg amputation. Herein, the role of a diabetic foot expert comes in to salvage the limb. The amputation rate can be brought to as low as three per cent if timely diabetic foot treatment is available to patients.
Says Dr T K Sahi, honorary surgeon, J J Hospital and professor, surgery, Grant Medical College, who has pioneered the treatment and management of salvaging of limbs in the end-stages of peripheral circulatory disease with or without diabetes, “Amputations can be avoided and limbs can be saved, even in the end stages of peripheral circulatory disease through surgical techniques like ‘Revascularisation by Omental Transfer’ and ‘Bilateral Simultaneous Revascularisation’.
Recognition of her work in salvaging limbs came when she was awarded the young researcher best paper award at the World Congress 2000 of the International College of Surgeons, which concluded in Suntec City at Singapore in October, 2000.
“Diabetic foot management is a highly specialised work requiring exceptional dedication as one has to deal with several issues like injury, infection, diabetes, non-healing ulcers, circulatory deficiencies and neuropathies,” adds Dr Sahi.
Why such an acute shortage of diabetic foot specialists? Dr Arun Bal, diabetic foot surgeon, Raheja Hospital, attributes the shortage to the absence of courses in podiatry in the medical curriculum at graduate or post graduate level. “Increase in diabetic foot patients is due to the lack of diabetic foot specialists at primary healthcare centres,” remarks Dr Bal.
The unavailability of diabetic foot specialists delays the diagnosis of diabetic peripheral neuropathy or diabetic foot and hence late referral to the specialty centres leads to an escalation in the cost of the treatment, point out experts. Diabetic foot experts, who are doing dedicated work are mostly self-trained. “The existing orthotists in the country, who make artificial limbs, orthopaedic shoes and belts, are not fully equipped to make the diabetic foot wear as their training is incomplete in various aspects of diabetic foot problems,” informs Dr Bal.
Amrita Institute of Medical Sciences, (AIMS), Cochin is the only institute in India offering one-year course in diabetic foot management for nurses, one-year diabetic foot surgery for surgeons and a two-year diabetic educators Course.
Simple patient education and cost-effective footwear would prevent 85 per cent of amputation. If this is not done in the future, the country will face tremendous economic loss
Dr Arun Bal
To iron out the hurdles, Dr Bal suggests simple patient education and cost-effective footwear, which would prevent 85 per cent of amputations. “If this is not done in the future, the country will face tremendous economic loss,” cautions Dr Bal. To make the treatment more affordable, there is a need to have indigenous instruments. While the cost of an indigenous sensitometer is Rs 22,000, the cost of an imported one is Rs 85,000. “Dhansai Lab, which manufacturers these equipment has been able to sell 500 to 1000 indigenous sensitometers with the support of DFSI, across the country in a year’s time,” informs Dr Bal. Even indigenous foot scanners should be made available at all the centres across the country.
According to Dr Harish Kumar, consultant endocrinologist, AIMS, Cochin, “The specialty can get a boost if manufacturing of diabetic foot wear and equipment for testing is regulated.” Diabetic Foot Society of India (DFSI) has set up a sub committee to standardise diabetic foot care in India and bring about guidelines for diabetic footwear. DFSI is also working to educate the doctors and nurses. World Diabetes Federation (WDF) is conducting a pilot project for training teams of doctors and paramedics on diabetic foot management at primary level across the country.“The solution to the problem lies in changing medical nursing, orthotist and physiotherapy curriculum. Nursing and orthotic curriculum should also incorporate chapters on diabetic foot management,” suggests Dr Bal.
Experts say that the government and private organisations should come forward in starting training courses at various levels for prevention and treatment of diabetic foot for doctors and paramedics.
Good manufacturing practices should be applied to make simple, cost effective and scientific foot wear. “Government should recognise the huge gap in therapy and academics, thus, starting a certified course in podiatry, setting up a foot clinic in all public hospitals and increasing the awareness through exhibitions, electronic and print media,” says Dr Rajiv Kovil, consultant diabetologist, Kovil Diabetes Centre.
Some of the problems of diabetic foot peculiar to our subcontinent is because people tend to walk barefoot.
“Not only do we not use footwear indoors, but a large section of our population do not use it even outdoors. Patients with severe neuropathy do not have any sensation and are unable to feel pain on injuring their feet. These injuries like cuts from sharp objects and burns from hot surfaces are likely to occur both indoor and outdoor. So once a patient has poor sensation and poor blood supply in the feet, i.e., a “high risk foot”, it is necessary to educate the patient and use appropriate footwear to prevent injuries and ulcers in the feet,” informs Dr Kovil.
shardulnautiyal@rediffmail.com
GENETIC LAB AND RESEARCH
What ail genetic lab service and research in India?
Shardul Nautiyal and Rita Dutta
A four-legged boy, born with two sets of penis, four testicles, two anal openings and a huge bulge in the abdomen recently created a furore in Lucknow, with even his parents refusing to take him home, unless he is surgically operated on to look like a normal child. The newborn is kept at Lucknow’s King George Medical University, where doctors are debating on the risks involved in such a surgery.
Why such a condition of “parasitic twins” could not be averted? Why was the mother not screened during pregnancy? With 50 million individuals affected with genetic disease, is India equipped with facilities and experts? In several populations, the diseases are also leading to their extinction. One such tribe are the primitive Onges of Andaman and Nicobar Islands, where the number has dwindled from 700 in 1858 to mere 98 this year.
Facilities
Genetic Diagnostic Centre, Mumbai offers guidance for setting up of new genetic labs
A decade back, to tackle with one in every 50 to 100 babies born with genetic birth defects, there were not more than ten full-fledged genetic labs in the country. Today, the metropolitan cities have genetic testing labs, providing biochemical, cytogenetic and molecular testing.
Underutilisation of services
The genetic labs may offer advanced tests like FISH, PCR and karotyping, but has the advancement reached the populace? Lack of awareness about such tests and high cost of tests are attributed for the less number.
The low number of tests reflect gross underutilisation of services. Says Dr S S Agarwal, medical geneticist, Central Drug Research Institute (CDRI), Lucknow, “There is a vicious cycle of demand and supply. Lack of awareness, both among the doctors and the public, as well as the cost, results in no demand for genetic tests and no demand leads to no supply.”
Echoes Dr Arvind Lal, Dr Lal’s Pathlab, New Delhi, “The number of tests conducted to detect Inborn Errors of Metabolism (IEMs) in newborn genetic screening are poor. We receive only around 10 samples a day of the 25 million babies born per year.” Since last year, Dr Lal’s Pathlabs is offering tandem mass spectometry which rules out 30 IEMs for newborns. There is resistance from paeditricians towards neonatal screening as they feel the frequency of IEMs is low to warrant routine screening.
Lack of experts
But even if the number of tests shoot up, there is an acute shortage of experts in the absence of institutes imparting training in genetics. Most geneticists go abroad for training and experience. There have been whispers of misinterpretation of reports because of lack of expertise.
Says Dr P Madon, geneticist, department of Assisted Reproduction and Genetics, Jaslok Hospital, Mumbai, “We have to train people for conducting such tests and interpreting results as DMLT course does not emphasis on genetics.” Only Sanjay Gandhi Post Graduate Institute of medical sciences (SGPGI), Lucknow offers a post graduate DM course in medical genetics. The Department of Biotechnology (DBT) has taken an initiative this year to start five training units in the field of diagnosis of genetic disorders using cytogenetics and molecular genetic methods in the country to train young scientists/ clinicians/technologists.
Not many experts pursue genetics as job openings for a geneticist is not bright in the public sector. Explains Dr Sharad Gogate, a Mumbai-based medical geneticist, “Highly trained geneticists fail in getting jobs in the public sector due to the beauracratic hurdles and reservation policies of the government. The geneticist finds greener pastures abroad or in private sector leading to brain drain.”
Treatment
Experts claim that treatment for genetic disorder has been hampered by lack of expertise. According to Dr Anil Jalan, consultant in paediatric metabolic disorder, MGM Hospital, Navi Mumbai, “Where are the experts to treat children with IEMs? As of now, we have a handful of experts.”
Echoes Dr Pravin Potdar, microbiologist, Jaslok Hospital, “Genetic disease is not curable, but preventable. Though we have the necessary instrumentation, we still lack in expertise required to treat the disorder.” Parents of children with genetic disorder find the imported dietary supplement required for IEM expensive. “With a can costing Rs 25,000, one has to spend Rs 3 lakh and above annually for the diet,” says Dr Jalan.
Absence of epidemiological study
Besides less number of tests and lack of experts, there is dearth of data on the prevalence of genetic disorder. Says Dr I C Verma, head, genetics department, Sir Gangaram Hospital, New Delhi, “There is no nation-wide study on the prevalence of genetic disorders. Most of the studies are hospital related which are extrapolated. The ICMR study (reported in August 1 to 15 issue of Express Healthcare Management) on incidence of IEM would be the first of its kind to find the incidence of genetic disorder in newborns.”
Lack of data on epidemiology affects choosing the right tests. Explains Dr S Suresh, director, Surendar Genetic Lab, Chennai, “In the absence of data, labs are at their wit’s end as to which tests they should conduct, as it’s not feasible for a lab to offer tests for over thousand disorders. Ideally, labs should offer tests for disorders which are prevalent in that area, as is practiced in the West.”
Recently, the Indian Society of Genetic Screening, comprising over 40 geneticists, has started Birth Defect Registry of India to look into the infrastructure of genetic lab testing in the country, informs Dr Suresh.
Accreditation
Though the National Accreditation Board for Testing and Calibration Laboratories, (NABL) has started accreditation of all laboratories including genetic labs, but not many labs have come forward. Says Dr A Radha Rama Devi, consultant and head, Center for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad, “Many private labs have taken up the diagnostic testing without any proper guidelines resulting in misdiagnosis. In our lab, we exchange samples with other labs to check our quality. For biochemical tests used in the newborn screening, our lab is accredited by Centre for Disease Control (CDC), USA.”
Issues related to Cancer Genetics
Although important discoveries occurred in cancer cytogenetics area during 1973-1990, the application of these studies to the patients was a gradual process. This was mainly due to the limitations of availability of skilled and experienced cancer cytogeneticists in the country. The molecular genetics technologies like PCR, blotting techniques, DNA sequencing etc became more popular in comparison with cytogenetics in the scientific community because they were user friendly and quick techniques that could easily be adopted by training.
Research
The scope for research in public hospital is wide with a vast patient base, large number of trained personnel and large student population. However, labs in private sector and biotechnology industry despite their good infrastructure, sophisticated equipment and a steadily increasing population ready to pay for these tests, face lack of research students and trained personnel.
According to Dr Saroj Kotwaliwale, medical geneticist, Genetic Diagnostic Centre, Mumbai, “There is hardly any research facility available in cancer cytogenetics and human cytogenetics as the finances for applied research and basic research is not available.”
Amongst the few centres which are conducting research, CDFD, Hyderabad has characterised gene locations in chromosomal translocations and in balanced chromosomal translocations associated with cancer. The research, supported by the Department of Biotechnology (DBT) was carried out in Germany with the Max Plank Institute. Further identification of the gene involved in the physical presentation in the case is being worked out.
“We also screen cervical samples for the presence of Human papilloma virus (HPV) by molecular testing and carry out typing to find out the cancer causing types among women in Andhra Pradesh. This study is useful for implementation of HPV vaccine use,” informs Dr Devi.
Other point out that research in medical genetics should be looked from the perspective of total medical genetics and cancer genetics, and not cytogenetics alone. Says Dr Shubha Phadke, additional professor, medical genetics, SGPGI, Lucknow, “The major research aspects of medical genetics in India are delineation of mutations in Indian patients with genetic disorders namely thalassemias, duchenne muscular dystrophy, Wilson disease, fragile X syndrome, etc. This type of research is useful in the establishment of tests for genetic disorders.”
According to Dr Kiran Kucheria, professor and head, department of anatomy and genetics, AIIMS, New Delhi, “Other than the research, diagnostic services using molecular cytogenetics is provided at very few centres in India. Over 50 labs providing services in human cytogenetics are conducting short-term research projects also.” Experts rue that hardly the results of the research are translated to improve genetic service.
Genetic labs also find the expensive reagents unaffordable for conducting research. “Each probe for molecular cytogenetic studies from Vysis costs USD 300. In the US, cost of an average test is USD 400 to USD 500. The tests for BRCA1 and BRCA2 could cost up to USD 3000,” adds Dr Agarwal.
Realising the potential, some biotech companies like Biocon have expressed their desire to conduct research in this area. Biocon chairman Kiran Mazumdar Shaw has reportedly said that the country’s unique gene pools are “gold mines”.
Genetic Lab Facilities at various hospitals in India
The cancer cytogenetics laboratory at Tata Memorial Hospital is engaged in basic and applied research programmes in hematological malignancies, urological malignancies and childhood malignancies like retinoblastoma and sarcomas. The laboratory has been actively involved in various large scale clinical research trial programmes of targeted drug therapies like Glivec in CML, ATRA in acute promyelocytic leukaemia (APL), NCI multi-centre chemotherapy trial in ALL for molecular assessment of targeted therapies by molecular cytogenetics. The laboratory reports more than 3000 tests annually. CMC, Vellore and Adiyar Cancer Research Center also provides cancer cytogenetics services.
Genetic Diagnostic Centre, Mumbai established in 1986 is the first laboratory in India to perform amniotic fluid cell cultures for prenatal diagnosis and till today has analysed more than 3000 samples recommended for cytogenetic diagnosis. The Centre provides genetic counselling, cytogenetic test from blood, chorion villous sampling, amniotic fluid cell cultures, Fetal blood sampling, Products of conception, among others. The centre also offers training courses for individuals interested in pursuing cytogenetics as a profession and also provides guidance for setting up of the new laboratory.
Some of the main subjects of study in medical genetics department of SGPGI, Lucknow are clinical delineation of new multiple malformation syndromes, not yet reported in the medical literature. Other aspects of research are psychosocial aspects of genetic counselling in Indian scenario, genetic variations in different ethnic group in Indian population and cancer genetics.
Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad is engaged mainly in providing human cytogenetics for a variety of disorders such as chromosomal defects in structure and in number. Human cytogenetic studies are carried out using the applied Imaging System and different banding techniques are applied for the diagnosis. A proposal has been made by CDFD to the Department of Biotechnology (DBT), Govt of India (GOI) for a cytogenetic workstation to study various cancers.
Suggestions for improvement
There is a need for a synergy between public and private sector for making genetic facilities a mutually beneficial business proposition. “The services of each sector can be efficiently utilised to convert basic research into clinical tests and service facilities, which will help generate funds for building the infrastructure of labs. Our intellectual property will also be protected this way,” avers Dr Gogate.
Indian scientists have awakened to the need to study the country’s endogamous gene pool. Due to India’s large population, many rare disorders exist in India. These families can contribute to identification of genetic defects of rare genetic disorders. Identification of cases with possible genetic etiology by primary care physicians is essential so that these families can get facilities of special genetic tests, genetic counseling and prenatal diagnosis. Thus the initiative of the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad in studying the origin and disease susceptibility of various caste and tribal populations of India comes as a good tiding.
Experts suggest that the government should reduce custom duty on imported equipment and reagent required for genetic labs. Other demand that there should be more Indian publication on medical genetics in India. “To address the lack of awareness in general population about genetic disorders, their screening and diagnostic tests, there should be awareness campaign. We also require a national directory of genetic centres/labs offering various tests and facilities for ready reference for clinicians so that patients can be guided for appropriate tests to suitable facility,” adds Dr Gogate.
Regarding the issue of very limited facility of cancer cytogenetics services in our country, Dr P S Amare , head, Cancer Cytogenetics Laboratory, Tata Memorial Hospital, Mumbai, says that translational research programmes are necessary for the diagnostic and prognostic correlation of genetic results, investigation of cytogenetics variants in a group of patients This leads to the establishment and implementation of studies with an approach to precise diagnosis and better management of disease. “Government-funding agencies should prioritise translational research programmes, which will provide a bridge between clinicians and lab scientists and foster a close link between clinic and laboratory. This will be instrumental in facilitating better quality cancer genetics service programmes with implementation of advanced eminent technologies in cancer diagnostics and disease management,” adds Dr Amare.
Government-funding agencies should prioritise translational research programmesDr P S Amare, Cancer Cytogenetics Laboratory, Tata Memorial Hospital
There is hardly any research facility in cancer and human cytogenetics because of lack of fundsDr Saroj Kotwaliwale,medical geneticist,Genetic Diagnostic Centre
The identification of a large number of single gene disorders will immensely help families with difficult genetic disorders Dr Shubha Phadke, addl professor, medical genetics, SGPGI, Lucknow
Significance of Human Genome Project
Thanks to the Human Genome Project, now one can make adequate lifestyle and environmental changes at an early age to eliminate the likelihood of disease or taking treatment at an appropriate early stage. Genome research will therefore ensure rapid and more specific diagnostic tests and help in creating drugs in response to individual’s genetic inheritance.
According to Dr Manjeet Kaur, head, department of genetics, Dr Lal PathLabs Pvt Ltd, “Drugs based on proteins, enzymes and RNA molecule associated with genes and diseases will be more effective than drug characterised by treating symptoms. Drug dosages based currently on weight and age will be replaced with dosages based on a person’s genetics, thus decreasing the likelihood of overdose.”
The project has revealed that merely the number of genes present does not determine the complexity of human genome compared to other organisms. The complexity is with respect to gene regulation and the number of different transcripts originating from a single gene. “The genome project has now given rise to the Proteome project in order to understand the functioning of the genes in terms of the batteries of proteins produced. Understanding of the differences in protein expression between a healthy individual to that of the diseased will pave newer ways for screening, diagnosis and therapeutics,” informs Dr Devi.
The human genome mapping has lead to identification of more than 400 genes for monogeneic or single gene disorders. “Identification of causative genes for these disorders have led to the establishment of tests for diagnosis and prenatal diagnosis for prevention of recurrences. This knowledge will be of immense help to the families with difficult genetic disorders,” informs Dr Phadke.
The other important aspect of human genome project is in the field of cancers and identification of genetic defects which predispose a person to common diseases like heart attack, high blood pressure, diabetes , psychiatric illnesses ,etc. A lot of research in this field is going on and may lead to newer modalities of treatment of cancers, say experts.
rita@expresshealthcaremgmt.com
shardulnautiyal@rediffmail.com
Shardul Nautiyal and Rita Dutta
A four-legged boy, born with two sets of penis, four testicles, two anal openings and a huge bulge in the abdomen recently created a furore in Lucknow, with even his parents refusing to take him home, unless he is surgically operated on to look like a normal child. The newborn is kept at Lucknow’s King George Medical University, where doctors are debating on the risks involved in such a surgery.
Why such a condition of “parasitic twins” could not be averted? Why was the mother not screened during pregnancy? With 50 million individuals affected with genetic disease, is India equipped with facilities and experts? In several populations, the diseases are also leading to their extinction. One such tribe are the primitive Onges of Andaman and Nicobar Islands, where the number has dwindled from 700 in 1858 to mere 98 this year.
Facilities
Genetic Diagnostic Centre, Mumbai offers guidance for setting up of new genetic labs
A decade back, to tackle with one in every 50 to 100 babies born with genetic birth defects, there were not more than ten full-fledged genetic labs in the country. Today, the metropolitan cities have genetic testing labs, providing biochemical, cytogenetic and molecular testing.
Underutilisation of services
The genetic labs may offer advanced tests like FISH, PCR and karotyping, but has the advancement reached the populace? Lack of awareness about such tests and high cost of tests are attributed for the less number.
The low number of tests reflect gross underutilisation of services. Says Dr S S Agarwal, medical geneticist, Central Drug Research Institute (CDRI), Lucknow, “There is a vicious cycle of demand and supply. Lack of awareness, both among the doctors and the public, as well as the cost, results in no demand for genetic tests and no demand leads to no supply.”
Echoes Dr Arvind Lal, Dr Lal’s Pathlab, New Delhi, “The number of tests conducted to detect Inborn Errors of Metabolism (IEMs) in newborn genetic screening are poor. We receive only around 10 samples a day of the 25 million babies born per year.” Since last year, Dr Lal’s Pathlabs is offering tandem mass spectometry which rules out 30 IEMs for newborns. There is resistance from paeditricians towards neonatal screening as they feel the frequency of IEMs is low to warrant routine screening.
Lack of experts
But even if the number of tests shoot up, there is an acute shortage of experts in the absence of institutes imparting training in genetics. Most geneticists go abroad for training and experience. There have been whispers of misinterpretation of reports because of lack of expertise.
Says Dr P Madon, geneticist, department of Assisted Reproduction and Genetics, Jaslok Hospital, Mumbai, “We have to train people for conducting such tests and interpreting results as DMLT course does not emphasis on genetics.” Only Sanjay Gandhi Post Graduate Institute of medical sciences (SGPGI), Lucknow offers a post graduate DM course in medical genetics. The Department of Biotechnology (DBT) has taken an initiative this year to start five training units in the field of diagnosis of genetic disorders using cytogenetics and molecular genetic methods in the country to train young scientists/ clinicians/technologists.
Not many experts pursue genetics as job openings for a geneticist is not bright in the public sector. Explains Dr Sharad Gogate, a Mumbai-based medical geneticist, “Highly trained geneticists fail in getting jobs in the public sector due to the beauracratic hurdles and reservation policies of the government. The geneticist finds greener pastures abroad or in private sector leading to brain drain.”
Treatment
Experts claim that treatment for genetic disorder has been hampered by lack of expertise. According to Dr Anil Jalan, consultant in paediatric metabolic disorder, MGM Hospital, Navi Mumbai, “Where are the experts to treat children with IEMs? As of now, we have a handful of experts.”
Echoes Dr Pravin Potdar, microbiologist, Jaslok Hospital, “Genetic disease is not curable, but preventable. Though we have the necessary instrumentation, we still lack in expertise required to treat the disorder.” Parents of children with genetic disorder find the imported dietary supplement required for IEM expensive. “With a can costing Rs 25,000, one has to spend Rs 3 lakh and above annually for the diet,” says Dr Jalan.
Absence of epidemiological study
Besides less number of tests and lack of experts, there is dearth of data on the prevalence of genetic disorder. Says Dr I C Verma, head, genetics department, Sir Gangaram Hospital, New Delhi, “There is no nation-wide study on the prevalence of genetic disorders. Most of the studies are hospital related which are extrapolated. The ICMR study (reported in August 1 to 15 issue of Express Healthcare Management) on incidence of IEM would be the first of its kind to find the incidence of genetic disorder in newborns.”
Lack of data on epidemiology affects choosing the right tests. Explains Dr S Suresh, director, Surendar Genetic Lab, Chennai, “In the absence of data, labs are at their wit’s end as to which tests they should conduct, as it’s not feasible for a lab to offer tests for over thousand disorders. Ideally, labs should offer tests for disorders which are prevalent in that area, as is practiced in the West.”
Recently, the Indian Society of Genetic Screening, comprising over 40 geneticists, has started Birth Defect Registry of India to look into the infrastructure of genetic lab testing in the country, informs Dr Suresh.
Accreditation
Though the National Accreditation Board for Testing and Calibration Laboratories, (NABL) has started accreditation of all laboratories including genetic labs, but not many labs have come forward. Says Dr A Radha Rama Devi, consultant and head, Center for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad, “Many private labs have taken up the diagnostic testing without any proper guidelines resulting in misdiagnosis. In our lab, we exchange samples with other labs to check our quality. For biochemical tests used in the newborn screening, our lab is accredited by Centre for Disease Control (CDC), USA.”
Issues related to Cancer Genetics
Although important discoveries occurred in cancer cytogenetics area during 1973-1990, the application of these studies to the patients was a gradual process. This was mainly due to the limitations of availability of skilled and experienced cancer cytogeneticists in the country. The molecular genetics technologies like PCR, blotting techniques, DNA sequencing etc became more popular in comparison with cytogenetics in the scientific community because they were user friendly and quick techniques that could easily be adopted by training.
Research
The scope for research in public hospital is wide with a vast patient base, large number of trained personnel and large student population. However, labs in private sector and biotechnology industry despite their good infrastructure, sophisticated equipment and a steadily increasing population ready to pay for these tests, face lack of research students and trained personnel.
According to Dr Saroj Kotwaliwale, medical geneticist, Genetic Diagnostic Centre, Mumbai, “There is hardly any research facility available in cancer cytogenetics and human cytogenetics as the finances for applied research and basic research is not available.”
Amongst the few centres which are conducting research, CDFD, Hyderabad has characterised gene locations in chromosomal translocations and in balanced chromosomal translocations associated with cancer. The research, supported by the Department of Biotechnology (DBT) was carried out in Germany with the Max Plank Institute. Further identification of the gene involved in the physical presentation in the case is being worked out.
“We also screen cervical samples for the presence of Human papilloma virus (HPV) by molecular testing and carry out typing to find out the cancer causing types among women in Andhra Pradesh. This study is useful for implementation of HPV vaccine use,” informs Dr Devi.
Other point out that research in medical genetics should be looked from the perspective of total medical genetics and cancer genetics, and not cytogenetics alone. Says Dr Shubha Phadke, additional professor, medical genetics, SGPGI, Lucknow, “The major research aspects of medical genetics in India are delineation of mutations in Indian patients with genetic disorders namely thalassemias, duchenne muscular dystrophy, Wilson disease, fragile X syndrome, etc. This type of research is useful in the establishment of tests for genetic disorders.”
According to Dr Kiran Kucheria, professor and head, department of anatomy and genetics, AIIMS, New Delhi, “Other than the research, diagnostic services using molecular cytogenetics is provided at very few centres in India. Over 50 labs providing services in human cytogenetics are conducting short-term research projects also.” Experts rue that hardly the results of the research are translated to improve genetic service.
Genetic labs also find the expensive reagents unaffordable for conducting research. “Each probe for molecular cytogenetic studies from Vysis costs USD 300. In the US, cost of an average test is USD 400 to USD 500. The tests for BRCA1 and BRCA2 could cost up to USD 3000,” adds Dr Agarwal.
Realising the potential, some biotech companies like Biocon have expressed their desire to conduct research in this area. Biocon chairman Kiran Mazumdar Shaw has reportedly said that the country’s unique gene pools are “gold mines”.
Genetic Lab Facilities at various hospitals in India
The cancer cytogenetics laboratory at Tata Memorial Hospital is engaged in basic and applied research programmes in hematological malignancies, urological malignancies and childhood malignancies like retinoblastoma and sarcomas. The laboratory has been actively involved in various large scale clinical research trial programmes of targeted drug therapies like Glivec in CML, ATRA in acute promyelocytic leukaemia (APL), NCI multi-centre chemotherapy trial in ALL for molecular assessment of targeted therapies by molecular cytogenetics. The laboratory reports more than 3000 tests annually. CMC, Vellore and Adiyar Cancer Research Center also provides cancer cytogenetics services.
Genetic Diagnostic Centre, Mumbai established in 1986 is the first laboratory in India to perform amniotic fluid cell cultures for prenatal diagnosis and till today has analysed more than 3000 samples recommended for cytogenetic diagnosis. The Centre provides genetic counselling, cytogenetic test from blood, chorion villous sampling, amniotic fluid cell cultures, Fetal blood sampling, Products of conception, among others. The centre also offers training courses for individuals interested in pursuing cytogenetics as a profession and also provides guidance for setting up of the new laboratory.
Some of the main subjects of study in medical genetics department of SGPGI, Lucknow are clinical delineation of new multiple malformation syndromes, not yet reported in the medical literature. Other aspects of research are psychosocial aspects of genetic counselling in Indian scenario, genetic variations in different ethnic group in Indian population and cancer genetics.
Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad is engaged mainly in providing human cytogenetics for a variety of disorders such as chromosomal defects in structure and in number. Human cytogenetic studies are carried out using the applied Imaging System and different banding techniques are applied for the diagnosis. A proposal has been made by CDFD to the Department of Biotechnology (DBT), Govt of India (GOI) for a cytogenetic workstation to study various cancers.
Suggestions for improvement
There is a need for a synergy between public and private sector for making genetic facilities a mutually beneficial business proposition. “The services of each sector can be efficiently utilised to convert basic research into clinical tests and service facilities, which will help generate funds for building the infrastructure of labs. Our intellectual property will also be protected this way,” avers Dr Gogate.
Indian scientists have awakened to the need to study the country’s endogamous gene pool. Due to India’s large population, many rare disorders exist in India. These families can contribute to identification of genetic defects of rare genetic disorders. Identification of cases with possible genetic etiology by primary care physicians is essential so that these families can get facilities of special genetic tests, genetic counseling and prenatal diagnosis. Thus the initiative of the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad in studying the origin and disease susceptibility of various caste and tribal populations of India comes as a good tiding.
Experts suggest that the government should reduce custom duty on imported equipment and reagent required for genetic labs. Other demand that there should be more Indian publication on medical genetics in India. “To address the lack of awareness in general population about genetic disorders, their screening and diagnostic tests, there should be awareness campaign. We also require a national directory of genetic centres/labs offering various tests and facilities for ready reference for clinicians so that patients can be guided for appropriate tests to suitable facility,” adds Dr Gogate.
Regarding the issue of very limited facility of cancer cytogenetics services in our country, Dr P S Amare , head, Cancer Cytogenetics Laboratory, Tata Memorial Hospital, Mumbai, says that translational research programmes are necessary for the diagnostic and prognostic correlation of genetic results, investigation of cytogenetics variants in a group of patients This leads to the establishment and implementation of studies with an approach to precise diagnosis and better management of disease. “Government-funding agencies should prioritise translational research programmes, which will provide a bridge between clinicians and lab scientists and foster a close link between clinic and laboratory. This will be instrumental in facilitating better quality cancer genetics service programmes with implementation of advanced eminent technologies in cancer diagnostics and disease management,” adds Dr Amare.
Government-funding agencies should prioritise translational research programmesDr P S Amare, Cancer Cytogenetics Laboratory, Tata Memorial Hospital
There is hardly any research facility in cancer and human cytogenetics because of lack of fundsDr Saroj Kotwaliwale,medical geneticist,Genetic Diagnostic Centre
The identification of a large number of single gene disorders will immensely help families with difficult genetic disorders Dr Shubha Phadke, addl professor, medical genetics, SGPGI, Lucknow
Significance of Human Genome Project
Thanks to the Human Genome Project, now one can make adequate lifestyle and environmental changes at an early age to eliminate the likelihood of disease or taking treatment at an appropriate early stage. Genome research will therefore ensure rapid and more specific diagnostic tests and help in creating drugs in response to individual’s genetic inheritance.
According to Dr Manjeet Kaur, head, department of genetics, Dr Lal PathLabs Pvt Ltd, “Drugs based on proteins, enzymes and RNA molecule associated with genes and diseases will be more effective than drug characterised by treating symptoms. Drug dosages based currently on weight and age will be replaced with dosages based on a person’s genetics, thus decreasing the likelihood of overdose.”
The project has revealed that merely the number of genes present does not determine the complexity of human genome compared to other organisms. The complexity is with respect to gene regulation and the number of different transcripts originating from a single gene. “The genome project has now given rise to the Proteome project in order to understand the functioning of the genes in terms of the batteries of proteins produced. Understanding of the differences in protein expression between a healthy individual to that of the diseased will pave newer ways for screening, diagnosis and therapeutics,” informs Dr Devi.
The human genome mapping has lead to identification of more than 400 genes for monogeneic or single gene disorders. “Identification of causative genes for these disorders have led to the establishment of tests for diagnosis and prenatal diagnosis for prevention of recurrences. This knowledge will be of immense help to the families with difficult genetic disorders,” informs Dr Phadke.
The other important aspect of human genome project is in the field of cancers and identification of genetic defects which predispose a person to common diseases like heart attack, high blood pressure, diabetes , psychiatric illnesses ,etc. A lot of research in this field is going on and may lead to newer modalities of treatment of cancers, say experts.
rita@expresshealthcaremgmt.com
shardulnautiyal@rediffmail.com
Friday, December 8, 2006
STATUS OF BONE MARROW TRANPLANT IN INDIA
What ails Bone Marrow Transplant in India
Bone Marrow Transplant programme, started way back in 70s, is crippled by expensive treatment, lack of specialists and shortage of transplant centres, finds out Shardul Nautiyal
Even as around 1000 patients require bone marrow transplants (BMT) every year and ideally 50 BMT centres should be offering the treatment, only around 200 patients are receiving the treatment annually from 15 BMT centres across the country. Of 15 BMT centers across the country performing both autologous and allogeneic transplants, 12 centres are performing BMTs regularly, inform experts. (See box for centres performing BMT).
BMT involves taking out stem cells from BM (cells present in the bone marrow). These are also present in blood (peripheral blood) in very small amount, in this case of a donor (sibling or unrelated) to be given to the patient/recipient (called as allogeneic BMT).
Why we require more BMT centres?
More BMT centres are required because the need for BMT is alarmingly high in malignant and non-malignant diseases all over India. Hospitals, having BMT facility, complain of overload of patients. For instance, CMC, Vellore has a waiting list of Indian patients for elective BM transplants till the June of next year. Besides this, BMT centres in India are attracting patients from countries like Pakistan, Maldives, Muscat, Oman, Dubai, Nepal and Mauritius.
According to Dr P M Shah, director, Gujarat Cancer Research Institute (GCRI), Ahmedabad, “The lack of centres is due to limited facilities in hospitals, high cost of treatment and less number of trained oncologists or BMT specialists in this field.”
Successful running of the BMT centre is possible only if we have dedicated oncologists. Says Dr P S R K Sastry, consultant medical oncologist, Tata Memorial Hospital, Mumbai, “After chemotherapy, there are complications like neutropenia, oncologists therefore play the role of a specialist and require a great deal of expertise.”
According to Dr Mammen Chandy, head, BMT Centre, Christian Medical College (CMC), Vellore, “Most doctors after doing D M (oncology) do not take much interest in this speciality as BMT is very difficult to perform.”
Orchestrating extensive support system is another arduous task. The support system requires trained oncologists, nursing staff, blood bank officers, radiation therapist, pathologist, microbiologist, biochemist and radiologist.
Status of BMT
Though the past decade has seen a dramatic and dynamic expansion in the clinical discipline of bone marrow and peripheral blood stem cell transplantation, BMT is still in infancy in India, feel experts. BMT programme in India is still not developed to tackle the patient overload in the country and from overseas.
According to Dr Lalit Kumar, medical oncologist, All India Institute of Medical Sciences (AIIMS), lack of awareness among the general or referring physicians, who refer the patients late, lack of co-ordination among the various departments in hospitals, where this facility is available and the cost involved contribute to its slow growth. “Increase in efficacy and safety of this mode of therapy is mainly due to refinements in technologies, supportive care and due to expansion of scientific knowledge of hematopoiesis and immunology, “ adds Dr Shah.
Success and advancement of BMT
Says Dr Maheboob Basade, medical oncologist, Jaslok Hospital, “Success rate is variable for BMTs in India. Overall mortality is less than five per cent for all kinds of BMT performed. It is less than one per cent for autologous BMT and less than 10 per cent for allogeneic BM transplants.”
It has been observed that the risk to the life due to Graft versus Host Disease (GVHD) occurs mostly in cases of allogeneic BM transplants. Experts pinpoint that mortality is more in matched unrelated transplants in comparison to matched related BM transplants. “Results in controlling GVHD has improved with the advent of newer drugs, effective in better immuno-suppression. The drugs are effective in selectively discarding T-cells or T-lymphocytes, which causes GVHD,” opines Dr Basade.
When BM transplantation was initiated for the first time in 1970, BM was used as a source of stem cells. But now almost 60 per cent of allogeneic transplants and almost 99 per cent of autologous transplants are being done using peripheral blood stem cells. “More than 6000 children and young adults also underwent transplantation using umbilical cord stem cells with equally good results,” says Dr Kumar.
Advancement in BMT are cord blood transplant, mini transplants and unrelated registry transplants. Other new developments are use of stem cells in the treatment of non-malignant diseases such as repair of myocardium and neurological disorders.
Other major advances in the field of hematopoietic stem cell transplantation are collection and purification of stem cells so that haplo-identical (half matched) transplants can be performed. “This implies that every patient can have a donor, as in this case, a parent will be half matched with the child. Another upcoming area is the use of stem cells for the purpose of gene therapy,” informs Dr Chandy.
The cost
Most hospitals are discouraged to have a BMT unit as the cost of setting it is very capital intensive and costs around Rs one crore.
The basic requirement to set up a transplant unit is hepa-filtered positive pressure rooms, facilities for collection, processing and cryo-preserving stem cells, with a support system in place like HLA lab for tissue matching through serology or preferably molecular based HLA typing. HLA typing generally costs Rs 3,000 to Rs 6, 000 per patient. The support system should also comprise of a bio-chemistry, microbiology and a blood component program.
The HLA typing lab is a capital intensive set up comprising a thermal cycler costing around Rs four lakh, Gel Documentation System costing around Rs four Lakh and the cost of the consumables like HLA trays costing around Rs 5,000 per tray. An electrophoresis instrument costing around Rs 1, 000 is also required.
The cost of BMT is generally around Rs 6-8 lakh for autologous and 10-12 lakh for allogeneic transplant. While the expense incurred on the BMT is estimated in actuals in a centre like TMH, centres like Jaslok Hospital offer a packaged deal.
The cost of BMT is expensive because of the cost incurred on the growth factors, for which one requires a cell separator and consumables. A cell separator, costs around 20 lakh and consumables costs Rs 100 USD per sitting on an average, depending on the patient, which is the recurrent cost.
Says Dr Harish Ahuja, senior pathologist and blood bank officer, Jaslok Hospital, “Stem cell harvesting contributes around 15 per cent of the cost for BMT, which also includes the cost of the disposables and consumables costing around one to Rs 1.5 lakh.” A BMT centre can ideally perform 15 to 18 cases a year, if the transplants performed are on a no-profit, no-loss basis.
One factor impacting the cost is that BMT is not covered under health insurance. “Only a small fraction of BMT cost can be reimbursed through insurance,” says Dr Sastry.
Lack of donors
BMT is also plagued by lack of donors. The chance of finding a matched related donor in a family is 25 per cent and one in a million for a matched unrelated donor. The situation becomes grave because of the lack of a wider donor pool for Indian patients requiring a matched bone marrow not only in the country but also globally. “It is difficult to find a match for Asians in registries from North America, Europe or Canada because Caucasians and Asians have a different set of genes,” says Dr Kumar.
Some of the major centres performing BMTs
Tata Memorial Hospital, Mumbai has performed over 250 BMTs till date with around 40 BMTs per year. TMH performed the first allogeneic bone marrow transplant in 1983. TMH performs BMTs for chronic myeloid leukaemia (CML), hodgkins disease, leukaemia, most acute leukaemias and certain lymphomas. TMH has performed 37 cases of Myeloma, 12 cases of thalassaemia major and 90 cases of CML till date.
Jaslok Hospital, Mumbai has performed around 70 transplants mostly in leukemia, myeloma, lymphomas and aplastic anemia. Country’s first and successful transplant for sickle cell disease was performed at Jaslok Hospital on a young Omani boy three years back.
Christian Medical College, Vellore has performed 506 allogeneic bone marrow/stem cell transplants and 109 autologous stem cell transplants since1986 and currently six allogeneic and three autologous stem cell transplant are performed every month. Allogeneic transplants have been done for thalassemia (160), Chronic myeloid leukemia (60), acute leukemia (60) , aplastic anaemia or a bone marrow failure (54) and many other conditions including rare genetic immuno-deficiency states. Autologous transplants are done mainly for acute leukemia, myeloma and lymphoma.The private mission hospital houses a three-bed stem cell translant unit, which will be upgraded to a ten-bed transplant unit very soon.
Apollo Hospitals, Chennai has has done 159 transplants till date including allogenic, autologous, cord blood and mini transplants. The commonest transplants were for multiple myeloma, acute myeloid leukemia and acute lymphoblastic leukemia. Transplants have also been done for thalassemia, aplastic anemia, and solid tumours. Nearly 75 per cent patients got discharged well after the transplants and more than 60 per cent are long term survivors.
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, New Delhi is doing almost 30 transplants annually. The centre completed 216 transplants till June 2005 and has the largest series on myeloma and has completed 79 transplants. The centre is currently using BM stem cells for the repair of myocardium and certain neurological disorders. AIIMS is trying to evaluate the role of stem cells in the treatment of certain eye diseases.
Kidwai Memorial Institute of Oncology, Bangalore started the transplant unit six months back and has performed three cases of myeloma.
Gujarat Cancer Research Institute, Ahmedabad performs one to two transplants in a month. The unit was started one year four months back and 32 patients have undergone BMT/PBSCT. The centre mainly focuses on conventional fully HLA matched sibling BM transplantation and autologous BM transplantation mainly in patients with malignancies.
Why we require bone marrow registry
To address the problem of lack of donors, the formation of a bone marrow registry is necessary. Having a good HLA typing facility is required to kick-start a bone marrow registry. Such registries are well developed in the west, but yet to make a beginning in India. In the absence of an operational bone marrow registry, TMH is in the preliminary stages of performing haploidentical HLA typed BM transplant cases.
Suggestions for improvement
A step by step approach is required to set up a BMT centre. “The BMT centre should perform autologous transplants first and then gradually switch over to allogeneic transplants. Performing autologous transplants first ensures that the BMT centre grows logistically,” opines Dr Sastry.
Experts say that autologous BMT is ideal as comparable to allogeneic BMT because there are less chances of infections in autologous transplants and therefore no risk of having GVHD.
According to Dr T Raja, senior consultant medical oncologist and senior consultant, BMT, Apollo Hospitals, Chennai, “In order to give a boost to allogeneic BMTs, the government needs to urgently set up good centralised HLA lab for all the hospitals across the country on payment basis. This will increase the chances of finding suitable donors within the country for many needy patients.” Patients undergoing BMT are also reported to have developed infections. Says Dr Vinod Raina, professor, medical oncology, AIIMS, “We are losing 10-30 per cent of transplant patients (depending on the type of transplants performed) and due to infections, many of which are fungal infections. This mortality due to infections can come down if facilites are improved and hospitals are made cleaner.”
The good news is that supportive care for infections and management of some of the complications has improved, reducing the risk of mortality to almost less than two per cent for autologous and less than 10 per cent for allogeneic transplant, say experts.
Experts suggest more involvement from the government, as the government has not been of much help in giving this specialty a boost. “Most of the pioneering work is done by the individual institutions in the various parts of the country,” says Dr Raja.
shardulnautiyal@rediffmail.com
Bone Marrow Transplant programme, started way back in 70s, is crippled by expensive treatment, lack of specialists and shortage of transplant centres, finds out Shardul Nautiyal
Even as around 1000 patients require bone marrow transplants (BMT) every year and ideally 50 BMT centres should be offering the treatment, only around 200 patients are receiving the treatment annually from 15 BMT centres across the country. Of 15 BMT centers across the country performing both autologous and allogeneic transplants, 12 centres are performing BMTs regularly, inform experts. (See box for centres performing BMT).
BMT involves taking out stem cells from BM (cells present in the bone marrow). These are also present in blood (peripheral blood) in very small amount, in this case of a donor (sibling or unrelated) to be given to the patient/recipient (called as allogeneic BMT).
Why we require more BMT centres?
More BMT centres are required because the need for BMT is alarmingly high in malignant and non-malignant diseases all over India. Hospitals, having BMT facility, complain of overload of patients. For instance, CMC, Vellore has a waiting list of Indian patients for elective BM transplants till the June of next year. Besides this, BMT centres in India are attracting patients from countries like Pakistan, Maldives, Muscat, Oman, Dubai, Nepal and Mauritius.
According to Dr P M Shah, director, Gujarat Cancer Research Institute (GCRI), Ahmedabad, “The lack of centres is due to limited facilities in hospitals, high cost of treatment and less number of trained oncologists or BMT specialists in this field.”
Successful running of the BMT centre is possible only if we have dedicated oncologists. Says Dr P S R K Sastry, consultant medical oncologist, Tata Memorial Hospital, Mumbai, “After chemotherapy, there are complications like neutropenia, oncologists therefore play the role of a specialist and require a great deal of expertise.”
According to Dr Mammen Chandy, head, BMT Centre, Christian Medical College (CMC), Vellore, “Most doctors after doing D M (oncology) do not take much interest in this speciality as BMT is very difficult to perform.”
Orchestrating extensive support system is another arduous task. The support system requires trained oncologists, nursing staff, blood bank officers, radiation therapist, pathologist, microbiologist, biochemist and radiologist.
Status of BMT
Though the past decade has seen a dramatic and dynamic expansion in the clinical discipline of bone marrow and peripheral blood stem cell transplantation, BMT is still in infancy in India, feel experts. BMT programme in India is still not developed to tackle the patient overload in the country and from overseas.
According to Dr Lalit Kumar, medical oncologist, All India Institute of Medical Sciences (AIIMS), lack of awareness among the general or referring physicians, who refer the patients late, lack of co-ordination among the various departments in hospitals, where this facility is available and the cost involved contribute to its slow growth. “Increase in efficacy and safety of this mode of therapy is mainly due to refinements in technologies, supportive care and due to expansion of scientific knowledge of hematopoiesis and immunology, “ adds Dr Shah.
Success and advancement of BMT
Says Dr Maheboob Basade, medical oncologist, Jaslok Hospital, “Success rate is variable for BMTs in India. Overall mortality is less than five per cent for all kinds of BMT performed. It is less than one per cent for autologous BMT and less than 10 per cent for allogeneic BM transplants.”
It has been observed that the risk to the life due to Graft versus Host Disease (GVHD) occurs mostly in cases of allogeneic BM transplants. Experts pinpoint that mortality is more in matched unrelated transplants in comparison to matched related BM transplants. “Results in controlling GVHD has improved with the advent of newer drugs, effective in better immuno-suppression. The drugs are effective in selectively discarding T-cells or T-lymphocytes, which causes GVHD,” opines Dr Basade.
When BM transplantation was initiated for the first time in 1970, BM was used as a source of stem cells. But now almost 60 per cent of allogeneic transplants and almost 99 per cent of autologous transplants are being done using peripheral blood stem cells. “More than 6000 children and young adults also underwent transplantation using umbilical cord stem cells with equally good results,” says Dr Kumar.
Advancement in BMT are cord blood transplant, mini transplants and unrelated registry transplants. Other new developments are use of stem cells in the treatment of non-malignant diseases such as repair of myocardium and neurological disorders.
Other major advances in the field of hematopoietic stem cell transplantation are collection and purification of stem cells so that haplo-identical (half matched) transplants can be performed. “This implies that every patient can have a donor, as in this case, a parent will be half matched with the child. Another upcoming area is the use of stem cells for the purpose of gene therapy,” informs Dr Chandy.
The cost
Most hospitals are discouraged to have a BMT unit as the cost of setting it is very capital intensive and costs around Rs one crore.
The basic requirement to set up a transplant unit is hepa-filtered positive pressure rooms, facilities for collection, processing and cryo-preserving stem cells, with a support system in place like HLA lab for tissue matching through serology or preferably molecular based HLA typing. HLA typing generally costs Rs 3,000 to Rs 6, 000 per patient. The support system should also comprise of a bio-chemistry, microbiology and a blood component program.
The HLA typing lab is a capital intensive set up comprising a thermal cycler costing around Rs four lakh, Gel Documentation System costing around Rs four Lakh and the cost of the consumables like HLA trays costing around Rs 5,000 per tray. An electrophoresis instrument costing around Rs 1, 000 is also required.
The cost of BMT is generally around Rs 6-8 lakh for autologous and 10-12 lakh for allogeneic transplant. While the expense incurred on the BMT is estimated in actuals in a centre like TMH, centres like Jaslok Hospital offer a packaged deal.
The cost of BMT is expensive because of the cost incurred on the growth factors, for which one requires a cell separator and consumables. A cell separator, costs around 20 lakh and consumables costs Rs 100 USD per sitting on an average, depending on the patient, which is the recurrent cost.
Says Dr Harish Ahuja, senior pathologist and blood bank officer, Jaslok Hospital, “Stem cell harvesting contributes around 15 per cent of the cost for BMT, which also includes the cost of the disposables and consumables costing around one to Rs 1.5 lakh.” A BMT centre can ideally perform 15 to 18 cases a year, if the transplants performed are on a no-profit, no-loss basis.
One factor impacting the cost is that BMT is not covered under health insurance. “Only a small fraction of BMT cost can be reimbursed through insurance,” says Dr Sastry.
Lack of donors
BMT is also plagued by lack of donors. The chance of finding a matched related donor in a family is 25 per cent and one in a million for a matched unrelated donor. The situation becomes grave because of the lack of a wider donor pool for Indian patients requiring a matched bone marrow not only in the country but also globally. “It is difficult to find a match for Asians in registries from North America, Europe or Canada because Caucasians and Asians have a different set of genes,” says Dr Kumar.
Some of the major centres performing BMTs
Tata Memorial Hospital, Mumbai has performed over 250 BMTs till date with around 40 BMTs per year. TMH performed the first allogeneic bone marrow transplant in 1983. TMH performs BMTs for chronic myeloid leukaemia (CML), hodgkins disease, leukaemia, most acute leukaemias and certain lymphomas. TMH has performed 37 cases of Myeloma, 12 cases of thalassaemia major and 90 cases of CML till date.
Jaslok Hospital, Mumbai has performed around 70 transplants mostly in leukemia, myeloma, lymphomas and aplastic anemia. Country’s first and successful transplant for sickle cell disease was performed at Jaslok Hospital on a young Omani boy three years back.
Christian Medical College, Vellore has performed 506 allogeneic bone marrow/stem cell transplants and 109 autologous stem cell transplants since1986 and currently six allogeneic and three autologous stem cell transplant are performed every month. Allogeneic transplants have been done for thalassemia (160), Chronic myeloid leukemia (60), acute leukemia (60) , aplastic anaemia or a bone marrow failure (54) and many other conditions including rare genetic immuno-deficiency states. Autologous transplants are done mainly for acute leukemia, myeloma and lymphoma.The private mission hospital houses a three-bed stem cell translant unit, which will be upgraded to a ten-bed transplant unit very soon.
Apollo Hospitals, Chennai has has done 159 transplants till date including allogenic, autologous, cord blood and mini transplants. The commonest transplants were for multiple myeloma, acute myeloid leukemia and acute lymphoblastic leukemia. Transplants have also been done for thalassemia, aplastic anemia, and solid tumours. Nearly 75 per cent patients got discharged well after the transplants and more than 60 per cent are long term survivors.
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, New Delhi is doing almost 30 transplants annually. The centre completed 216 transplants till June 2005 and has the largest series on myeloma and has completed 79 transplants. The centre is currently using BM stem cells for the repair of myocardium and certain neurological disorders. AIIMS is trying to evaluate the role of stem cells in the treatment of certain eye diseases.
Kidwai Memorial Institute of Oncology, Bangalore started the transplant unit six months back and has performed three cases of myeloma.
Gujarat Cancer Research Institute, Ahmedabad performs one to two transplants in a month. The unit was started one year four months back and 32 patients have undergone BMT/PBSCT. The centre mainly focuses on conventional fully HLA matched sibling BM transplantation and autologous BM transplantation mainly in patients with malignancies.
Why we require bone marrow registry
To address the problem of lack of donors, the formation of a bone marrow registry is necessary. Having a good HLA typing facility is required to kick-start a bone marrow registry. Such registries are well developed in the west, but yet to make a beginning in India. In the absence of an operational bone marrow registry, TMH is in the preliminary stages of performing haploidentical HLA typed BM transplant cases.
Suggestions for improvement
A step by step approach is required to set up a BMT centre. “The BMT centre should perform autologous transplants first and then gradually switch over to allogeneic transplants. Performing autologous transplants first ensures that the BMT centre grows logistically,” opines Dr Sastry.
Experts say that autologous BMT is ideal as comparable to allogeneic BMT because there are less chances of infections in autologous transplants and therefore no risk of having GVHD.
According to Dr T Raja, senior consultant medical oncologist and senior consultant, BMT, Apollo Hospitals, Chennai, “In order to give a boost to allogeneic BMTs, the government needs to urgently set up good centralised HLA lab for all the hospitals across the country on payment basis. This will increase the chances of finding suitable donors within the country for many needy patients.” Patients undergoing BMT are also reported to have developed infections. Says Dr Vinod Raina, professor, medical oncology, AIIMS, “We are losing 10-30 per cent of transplant patients (depending on the type of transplants performed) and due to infections, many of which are fungal infections. This mortality due to infections can come down if facilites are improved and hospitals are made cleaner.”
The good news is that supportive care for infections and management of some of the complications has improved, reducing the risk of mortality to almost less than two per cent for autologous and less than 10 per cent for allogeneic transplant, say experts.
Experts suggest more involvement from the government, as the government has not been of much help in giving this specialty a boost. “Most of the pioneering work is done by the individual institutions in the various parts of the country,” says Dr Raja.
shardulnautiyal@rediffmail.com
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