Roche
in HIV – A record of achievement and major commitment
Sight
& Life
India has a
HIV prevalence of 4 million, in a population of one billion,
this means that very large number of people are living with
the virus, more than any other country in the world except South
Africa.
Since the first
case of AIDS was detected in 1986, the epidemic now represents
the most serious public health problem in India.
In a country
where 95% of people with HIV cannot afford antiretroviral therapy
and where the policy is to treat only the opportunistic infections
resulting from the disease and not the virus itself, the fatal
consequences of HIV infection are inevitable. In addition, the
social stigma associated with HIV/AIDS in India means, for many,
loss of employment, medical and social benefits, friends, family
and freedom of movement.
India’s response
to the alarming spread of HIV infection throughout the country
has been quickly established a comprehensive set of prevention
and control measures through the National AIDS Control Programme
(NACO), an organisation responsible for the formulation and
implementation of the policy on HIV/AIDS. NACO operates through
‘outreach’ State AIDS Control Society and, in appreciation of
the multi-faceted nature of the disease, collaborates with government
agencies, the health and business communities, non –governmental
and voluntary organisations, Indian Railways, Pubic Sectors
Units and the Director General of Armed Forces Medical Services.
Significant funding in 1998 from the World Bank and UNAIDS (US$
96M) contributed to these programmes of reform which focused
primarily on community awareness programmes.
These large-scale
prevention programmes are resulting in safer sexual behaviour
and, if sustained, may lead to a reduction in the rates of HIV
infection. However, there has been little progress in India
on a policy for either the treatment of HIV (except for opportunistic
infections), or the provision of sensitive testing equipment
for HIV diagnosis and monitoring.
With HIV drug
expenditure as little as US$6 per HIV-infected person per year,
the system for benefiting from increased access to the drugs
do not exist. There are no patent protection laws in India and
generic companies can sell cheaper versions of the drug if they
are able to manufacture them by a different process from the
original branded drug. Despite this, some 3 million people with
HIV in India still go untreated whilst the Indian generic drug
companies compete to supply generic AIDS drugs to sub-Saharan
Africa. Patent protection and the price of medication is not
the major barrier to care in the developing world. Successful
management of HIV is dependent on the comprehensive programme
of education and awareness raising, supported by an effectively
organised healthcare system and underpinned by cultural adaptation,
prevention strategies and appropriate treatment options.
Governed by
the principles that drive the BlueSky Global Initiatives in
Caring, Roche in India has, in the last five years, worked on
various initiatives in partnership with NACO, healthcare professionals,
the Indian Government and the Armed Forces to find cost effective
HIV therapy solutions in this generic-dominated environment.
Roche
in HIV – A record of achievement and major commitment
Roche is
at the forefront of efforts to combat HIV and AIDS, committed
for 15 years to ground – breaking research and development of
award – winning new drugs and diagnostic technology, to provide
tailored treatment solutions and an improved standard of care
worldwide for those people living with HIV.
Today’s
Solution
There
is not cure for HIV infection but the introduction of the first
protease inhibitor, INVIRASE (saquinavir) by Roche in 1995,
made possible the advent of a revolutionary new era in HIV management,
that of highly active antiretroviral therapy (HAART), more commonly
described as ‘combination therapy’. This treatment approach
which lies on the combined inhibitory effect of three or more
drugs on the replication of HIV in the cell, has dramatically
improved survival rates for people with HIV. The original protease
inhibitor molecule, saquinavir, has received numerous awards
for ground – breaking drug research, the most prestigious being
the International Prix Galien in 1998.
Pioneering
medicines
Roche
provides a broad range of HIV treatments currently used in HAART.
One of these is the protease inhibitor VIRACEPT (nelfinavir)
a widely used HIV medicine due to its potent and durable antiretroviral
activity. Used in daily HAART regimen, that is often complex,
the twice daily dose schedule of VIRACEPT is of real benefit
to people in the day – to – day management of their disease.
This, together with a good tolerability profile compared with
other antiretrovirals has led to its widespread role in HAART.
Roche
also makes HIVID (zalcitabine), a reverse transcriptase inhibitor,
which has been proven to significantly prolong survival and
reduce the onset of opportunistic infections.
CYMEVENE/CYTOVENE
(ganciclovir) was developed by Roche to prevent and treat cytomegalovirus
(CMV) and is currently the most widely prescribed anti-CMV medication
worldwide. CMV is a common virus; normally dormant in healthy
individuals, but which can become active in people with weakened
immune systems. If it attacks the eye, the infection can cause
blindness if not treated.
The
use of HAART has reduced the incidence of AIDS and, subsequently,
CMV infection. Nevertheless, Roche is developing VALCYTE, valganciclovir,
an oral formulation of ganciclovir, in response to the need
of a convenient and practical alternative to intravenous (IV)
infusion and one which eliminates the risk of infection and
sepsis often associated with long term IV catheterisation.
VALCYTE
was approved in the U.S in March 2001 for the treatment of CMV
retinitis in people who have AIDS and remains under development
in other regions
Innovative research
Roche invests significantly in HIV research. Pivotal studies
conducted with INVIRASE has shown a dramatic improvement in
AIDS – free survival, and a soft gel capsule formulation of
saquinavir, FORTOVASE, was developed by Roche and brought to
the market in 1997. Data from four studies, presented at an
international HIV therapy workshop in the Netherlands in April
2001, has added further support for the investigational use
of FORTOVASE, combined with a low booster dose of ritonavir
to provide a potentially new, potent, twice or once – daily,
cost effective HIV treatment strategy.
Many people living with HIV are also
infected with hepatitis C and Roche is currently developing
a once – weekly, pegylated form of interferon, PEGASYS (peginterferon
alfa-2a) for the treatment of this condition.
Roche continues its search of innovative
solutions in the management of HIV and AIDS and currently research
programmes are broad – ranging in their pursuit of improved
formulations and regimens to make a difference to the lives
of people living with the virus. In addition, the search for
novel compounds with different mechanisms of action, the key
to combating drug resistance strains of HIV, is a priority for
the company.
Drug classes under investigations
by Roche:
Protease inhibitors, non – nucleoside
reverse transcriptase inhibitors, chemokine receptor inhibitors,
novel fusion inhibitors and RnaseH inhibitors.
Diagnostic expertise
Roche has also pioneered polymerase
chain reactor (PCR) technology, the most advanced method in
molecular diagnostics for the rapid and reliable detection in
the blood of infectious disease like HIV. This technology earned
its discoverer and Noble prize and Roche’s PCR – based products
now make it possible to monitor HIV disease progression and
response to therapy, resulting in earlier detection and treatment,
and improved individualised patient care.
The same methodology is used worldwide
to ensure the safety of donated blood and blood products.
In 1994, Roche’s AMPLICOR HIV-1 Monitor
became the first commercial test to accurately measure HIV-1
RNA in the blood (‘viral load’). This highly sensitive test
can detect very low viral loads, well below the cut – off for
other test. This degree of accuracy so vital to the success
and durability of HIV therapy ensures that the AMPLICOR HIV-1
Monitor remains only test approved by the FDA for viral load
measuring.
Tomorrow’s
promise
In collaboration with biotechnology
companies, Trimeris Inc., USA., and Progenics Pharmaceuticals
Inc., U.S.A., and their work on the discovery and development
of new classes of anti – HIV drugs, Roche is again actively
pursuing a completely new approach in HIV therapy.
The most advanced of these are the
fusion inhibitors and together Roche and Trimeris will invest
CHF 840 million (US$ 490 million) over the coming years to develop
T-20 and T-1249, the two most promising members of this important
new class of HIV therapy. Unlike traditional HIV/AIDS drugs,
all of which work inside the already infected cell, fusion between
the virus and the cell, the process that normally results in
viral replication.
Clinical trial data show that T-20
produces a potent anti – HIV effect, even in people who have
had extensive previous exposure to existing HIV medications.
There are the people who are at greater risk of treatment failure
because of drug induced HIV resistance and are the people in
greatest need of new options of new drugs.
A
major commitment
By combining its existing anti – HIV treatment and cutting edge
diagnostic technology with the potential of new research compounds,
Roche is adopting an integrated approach to addressing the challenges
of HIV and AIDS. In this way, Roche is committed to finding
and delivering more effective long – term health care solutions
to people living with HIV.
Sight & Life
Vitamin A program in India- why
the controversy?
Dr Vinodini Reddy, Former Director
National Institute of Nutrition, Hyderabad 500007 A.P., India
A Vitamin A supplementation program
has been in operation in India since 1970. Under this programme,
sponsored by the Ministry of Health and Welfare (GOI), children
aged between 9 months to 3 years are given six monthly doses
of Vitamin A, and the administration of the first two doses
is linked with routine immunisation. Although the supplementation
programme was initially started as a short tern measure
to prevent blindness in children, it has been going on for the
last three decades and its continuation has become a subject
of national debate. The recent reports of child deaths after
the administration of vitamin A during a mass campaign in Assam
triggered a fresh controversy over the Vitamin A program (1-3).
The controversy is not confined to the campaign approach for
vitamin A distribution, but the very existence of Vitamin A
deficiency (VAD) as a public health problem in India and the
need for supplementation are questioned (4). Such debates
often cause a set-back to the on-going programme, which is already
suffering from tardy implementation. An attempt is made here
to review the available data and answer some of the questions
raised by the critics.
Is VAD a public health problem
in India?
Clinical deficiency: Severe deficiency
of vitamin A is know to produce corneal xeropthalmia/keratomalacia
and blindness in children. Such cases are rarely seen in a community
survey and require a large sample size for accurate estimates
of prevalence. Hospital records show a significant decline in
keratomalacia cases in the last two decades and clinicians vouch
for its rarity. However, clinical signs of mild xeropthalmia
like Bitot's spots and night blindness are still seen among
children in deprived communities. The first repeat survey of
the National Nutrition Monitoring Bureau (NNMB) conducted during
1988-1990, in the same villages as those surveyed earlier during
1975-1979, showed that the prevalence of Bitot's spots has declined
from 1.8% to 0.7% (7). But the second repeat survey conducted
in 1996-1997 showed no further improvement (8) and the prevalence
is still above 0.5%(figure 1), the WHO cut-off level for a public
health problem. The national averages do not give a full picture
because the prevalence rate vary widely, not only between the
states but also within a state. Nevertheless, they provide useful
information on time trends.
Prevalence of Bitot's spots in
pre-school children
India nutrition Profile (1999)
is often quoted to show low prevalence of clinical deficiency
in the population, but the prevalence rates Bitot's spots published
in this reports cannot be used because they are based on pooled
data of all age groups. In few states like Haryana, Assam, and
Orissa, for which the data on preschool children are given separately,
the prevalence is relatively higher. A Survey in five north-eastern
states (Assam, Bihar, Orissa, West Bengal and Tripura) showed
the prevalence of Bitot's spots to be 0.7 - 2.2 % and that of
night blindness 1.2 - 4.0 % indicating a public health problem
in all five states. the survey also showed high prevalence of
night blindness among pregnant women (3.2 - 16%). The district
wise data collection in the state of Uttar Pradesh showed Bitot's
spots in 5.6% of children. There was a wide variation in the
prevalence between the districts and even within a district
from cluster to cluster, ranging from 0.2% to 13.7%. A recent
survey of the Indian Council of Medical Research (ICMR) (1998)
covering 16 districts mostly northern and eastern regions, showed
that the prevalence of Bitot's spots ranged from 0 - 4.7 % and
that of night blindness from 0.4 - 4.8 %. Low prevalence of
Bitot's spot observed in a number of districts surveyed in used
to argue that VAD is no longer a public health problem, but
the prevalence of night blindness, though a subjective sign,
cannot be ignored. If both indicators are used, VAD is a significant
problem in 7 districts and if the prevalence of corneal scares
( > 0.05%) is also considered, 11 out of 16 districts have
a significant problem. It must be recognised that all the available
clinical and biochemical indicators are subject to limitations.
And therefore WHO has recommended that at least 2 indicators
should be used for assessing the vitamin A status of a population.
Sub-clinical deficiency: It is
well recognised that xeropthalmia represents and advanced state
of deficiency. In communities where clinical signs of VAD are
seen, sub - clinical deficiency can be expected to be more common.
Large - scale data on serum retinol levels are not available
to access the extent of biochemical deficiency. But the community
studies carried out in Andhra Pradesh, Tamilnadu, and Uttar
Pradesh indicate that 30-50% of children have retinol levels
below 20 µg/dl, the WHO cut-off indicating a public health problem.
These observations are corroborated by the dietary data. Green
leafy vegetables, milk, and milk products are the major sources
of vitamin A in Indian diets. Surveys carried out in different
parts of the country show low consumption of these foods. The
average intake of vitamin A is around 300 µg in women and 120
µg in children, more than 80% have intakes less than 50% of
the recommended dietary allowance (RDA).
Thus the available data show that
though the severe forms of blinding malnutrition have declined
in the last two decades, milder grades of VAD still exist in
many parts of India. National surveys provide only state level
information and the limited data available from districts surveys
show a wide variation between the districts. The magnitude of
the public health problem varies depending upon the areas surveyed
and the indicators used.
Is mild VAD a public concern?
Apart from causing ocular signs
VAD is known to produce systemic changes, of which the most
significant effects are alterations in epithelial integrity
and immune status. Evidence of an association between VAD and
infection was documented by Scrimshaw et al. some 30 years ago.
Since then, supporting data from animal experiments and observational
studies in humans have been published. Positive association
between mild xeropthalmia and the risk of respiratory infection
was reported in Indian children, while Indonesian children showed
an association of both diarrhoea and respiratory infection.
Children with clinical signs of VAD were found to be at greater
risk of death that those without. A subsequent intervention
trial in Indonesia showed a 34% reduction in mortality among
children receiving six monthly doses of 200,000 IU vitamin A.
This effect was seen even in children without clinical signs,
highlighting the importance of sub-clinical deficiency. Controlled
trials in other countries also resulted in a significant reduction
in mortality- 19% in Ghana and 30% in Nepal. The reduction was
attributed to a fall in deaths related to diarrhoea and measles.
However, studies in India and Sudan using the same dose showed
no effect. Trials of weekly supplements in India and food fortification
in Indonesia showed higher reduction in mortality, indicating
that the beneficial effect was due to improvement in vitamin
A status by whatever means. A meta-analysis of data from eight
intervention trials in pre-school children showed an average
of 23% reduction in total mortality. However, this conclusion
has been challenged because the results are not consistent.
Subsequent studies in infants less that 6 months old have also
showed variable results. Administration of a single-dose of
50,000 IU of vitamin A to neonates in Indonesia resulted in
a significant reduction in mortality risk, while similar trial
in Nepal showed no effect. In WHO multicentre trial in Peru,
Ghana and India, vitamin A supplements (25,000 IU) given along
with DPT immunisation at 6, 10 and 14 weeks did not affect morbidity
or mortality. There are a number of potential explanations for
the variability in results across trials. These include age
of the children and the dosage schedule; smaller and frequent
doses seem to be more protective than larger periodic doses.
High prevalence of infections resulting in vitamin losses and
depletion of stores can shorten the protective period of supplements.
Vitamin A is likely to have greater effects in areas where VAD
is highly prevalent. Other factors like concomitant nutritional
deficiencies and access to healthcare can also modify the morality
effect. Thus the impact of vitamin A may vary depending upon
environmental conditions. An average 23% reduction in mortality
may not be applicable to all ecological settings, but the positive
impact of vitamin A in some situations can not be denied. After
reviewing the studies on vitamin A and mortality, a National
Consultation on the Benefits and safety of vitamin A Administration,
held in New Delhi in September 2000, concluded that the data
are "not robust" enough to recommend vitamin A supplementation
for the purpose of mortality reduction in children. In India,
infant deaths comprise up to 80% of under - five mortality in
some state and therefore it is argued that an intervention with
possible effects only beyond in fancy will not be of much value
for reducing child mortality.
In is true that vitamin A is not
a panacea for all the illnesses that affect children in developing
countries. However, the need for improving vitamin A status
cannot be denied. The fact that a majority of the population
subsist on inadequate diets, with vitamin A intakes less than
half the recommended level and a significant proportion of children
having clinical and sub-clinical deficiency in a matter of public
health concern. The aim of the National Nutrition Policy is
not only to prevent blindness in children, but also to eliminate
VAD as a public health problem. There is thus a need to accelerate
the intervention efforts to achieve the goal.
What are the appropriate strategies
for VAD control?
Multiple approaches including vitamin
A supplementation, food fortification, dietary diversification
and public measures have been suggested for prevention and control
of VAD. Although pilot projects have demonstrated their efficacy
and feasibility, large-scale implementation of these programs
have met with limited success. This has led to considerable
debate as to which of the interventions is most cost-effective
and sustainable. Their choice is not simple. Each one has its
strengths and limitations. For maximum impact and efficacy,
each strategy should be considered in the context of a country's
needs/priorities and its capacity to implement and sustain as
intervention.
Vitamin A supplementation is the
quickest way of improving the vitamin A status of a population
and is the choice of strategy in areas where the problem is
widely prevalent. Improving the diet, even if it is difficult
to achieve in the short term, is of paramount importance, as
it contributes to improving the overall nutritional status.
Food fortification with vitamin A has proved to be an effective
strategy for reducing VAD in some countries. A right mix of
interventions tailored to the local circumstances is more likely
to succeed in achieving the objective.
In India, the National Vitamin
A Prophylaxis Program was started with the primary aim of reducing
blindness in children, which was a significant problem at that
time. Under this program sponsored by the Ministry of Health
and Family Welfare, children aged between 1 and 5 years were
given oral doses of 200,000 IU vitamin A every 6 months. Evaluation
studies in the late 1970s revealed poor implementation of the
program and inadequate coverage in most of the states. The program
was reviewed several times since then, and efforts were made
to correct existing deficiencies. Currently, vitamin A is given
only to children aged less that 3 years who are at greater risk,
and administration of the first two doses is linked with routine
immunisation to improve coverage. 100,000 IU vitamin A are given
along with measles vaccine at 9 months of age and 200,000 IU
with DPT booster at 15 months.
In recent years, there has been
considerable debate on the continuation of the vitamin A supplementation
program. Since keratomalacia/blindness is no longer a significant
problem, it is argued that there is no need for supplementation
and that milder forms of deficiency can be tackled through alternate
strategies aiming at dietary improvement. It is true that dietary
intervention is the most logical approach. Right from the beginning
supplementation was conceived as an interim measure to be discontinued
once the dietary improvement was achieved. Unfortunately, the
dietary situation has not changed in the last three decades.
Vitamin A intake of children is less that half the RDA even
today, with a significant proportion of them having clinical
evidence of deficiency. Under these circumstances, it is not
wise or ethical to withdraw the benefits of supplementation.
There is also a controversy about
the universal approach currently adopted, because VAD is not
uniformly spread throughout the country. The cost of a vitamin
A supplement is estimated to be Rs.3.20 (0.06 USD) per child
per year, which is a negligible proportion of the total health
expenditure. A selective approach, covering only the districts
where VAD is a public health problem, would be a more cost-effective
strategy. It requires district mapping for VAD signs all over
the country. This is possible if the states take responsibility
for conducting surveys and monitoring the program. When such
data are not available, priority should be given to backward
areas, identified by the ecological indicators.
The mode of delivery of the vitamin
has also been a subject intense discussion. Under the national
programme, children are given vitamin A along with routine immunisation
(measles, polio, DPT). While the international agencies have
been vigorously promoting supplementation linked with routine
as well as campaign-based immunisation, it is regarded not as
a short-term measure but as a low-cost sustainable strategy
to combat VAD in developing countries. Efforts are also made
to expand the program to cover pregnant and lactating women,
and infants below 6 months, though studies have failed to demonstrate
clear benefits in these groups. These efforts have met great
resistance in the Indian context. In recent years, Pulse Polio
Immunisation (PPI) has been implemented as a national campaign,
offering an opportunity for delivering vitamin A. But the Indian
Academy of Paediatrics disapproved linking vitamin A with PPI,
primarily due to lack of sufficient evidence for the benefit
of supplements in infancy, chances of destabilisaton of routine
services and the fact that PPI is a temporary program. Of the
two states which included vitamin A in the PPI campaigns during
1990-2000, improved coverage was achieved in Orissa but not
in Uttar Pradesh due to poor logistic support. Considering the
inconsistent results and the fact that PPI itself is coming
to an end, the National Consultation on vitamin A should not
be linked with PPI. Instead, the ongoing program of supplementation
linked with routine immunisation should be strengthened to achieve
high coverage (> 90%) for atleast the first two doses. There
is also a need to strengthen the education component of the
program to improve the diet as a long term goal.
Dietary improvement is, undoubtedly,
the most logical and sustainable strategy to prevent VAD. Its
contribution to improvement in overall nutrition justifies continued
efforts in this direction. There is a general consensus on this
at both the national and international levels. However, past
efforts concentrated on supplementation and not much attention
was paid to planning and implementation of food-based programmes.
It is often stated that green leafy vegetables (GLV) and fruits
are available in plenty during season and well within the economic
reach of even the poor. Availability alone, however does not
ensure programmatic success. This requires a change in dietary
habits and increased access to vitamin-A rich foods. In recent
years, efforts have been made to achieve these objectives through
educational and horticultural interventions. however, these
are mostly small-scale projects and are yet to be incorporated
into national programmes. Even these projects have failed to
demonstrate a significant impact on vitamin A status because
they focused on GLV as the main source of vitamin A. Bioavailability
of ß - carotene is lower from GLV than from other vegetables
and fruits. Young children cannot consume leafy vegetables in
sufficient quantities to meet the vitamin A requirement. Based
on feeding trials with selected vegetables, a factor of 26(
instead of 6) has been suggested for conversion of ß-carotene
to vitamin A. However, this is debated because Bioavailability
of carotene varies widely and depends not only on the food source
but also on the way it is prepared, as well as on the level
of other dietary components like fibre and fat. A detailed discussion
of this issue is beyond the scope of this section. But it must
be admitted that promotions of GLV alone is unlikely to eliminate
VAD. Dietary diversification programmes must include a variety
of vegetables and fruits as well as animal foods like milk and
egg. We should not just settle for something "cheap",
but make all efforts to improve the quality of diet.
What went wrong with the vitamin
A campaign in Assam?
The reported deaths of over a dozen
children and a large number of children falling sick after vitamin
A administration during a mass campaign in the north-eastern
state of Assam has caused considerable anxiety and concern among
health professionals. The campaign was stopped immediately and
an inquiry was set up by the Government. Some doctors blamed
the stock of vitamin A supplied. However, testing of vitamin
A samples from batches used in the campaign showed nothing wrong
with the vitamin A supplied. They conformed to the standards
of quality specifications, so the reported adverse reactions
were not attributable to the quality of product supplied.
Some nutritionists have questioned
the campaign approach adopted by the state, when the national
guidelines recommend vitamin A administration along with routine
immunisation. Unfortunately, the national immunisation coverage
for atleast one dose of vitamin A (linked with immunisation)
is only 30% and in Assam, it is even lower at 15.4%. Recently,
some of the states in India including Assam have initiated
vitamin A campaign, with UNICEF support, to improve the coverage.
This is the third round of vitamin A distribution in Assam,
and the first two rounds in this state as well as other states
like Andhra Pradesh, Karnataka and Orissa were uneventful. During
this round, UNICEF has replaced the traditional 2ml spoons with
5 ml cups for administering vitamin A. It is possible that this
switch in the method and inadequate training of health workers
might led to overdosing in some cases. Though the cup had 2ml
markings, health workers cannot be expected to measure the dose
accurately, especially in a mass campaign where hundreds of
children are covered in a day.
Administration of large doses of
vitamin A is known to produce side effects like headaches, vomiting
and bulging fontanel in 1-2% of children, but these symptoms
are mild and disappear within 4 hours. According to the newspaper
reports, up to 15,000 children, out of 3 million who received
vitamin A during the campaign, became ill. This is much less
than what is expected (up to 60,000) with vitamin A doses.
The Assam episode started with
the death of a two-year-old child from the Tea garden community,
after consuming vitamin A. This triggered panic amongst the
parents, and thousands of people rushed with their children
to the nearest health care centre, some of them complaining
of fever, vomiting and diarrhoea. Normally, these symptoms do
not attract mass attention. But the media has sensationalised
the event in Assam leading to a wave of mass concern. All deaths
and illnesses that occurred in children during the following
week were attributed to vitamin A. There is no evidence that
vitamin A will cause death even if a child has received twice
the amount. (40,000 IU). this is the dose recommended by the
WHO for the treatment of xeropthalmia. Vitamin A programmes
have been in operation for the past several years not only in
India, but also in 60 other countries. So far, not a single
case of death attributable to vitamin A dosing was reported.
Lethal dose of vitamin A is not known, but a review of the case
reports of children getting 30,000 - 90,000 IU do not suggest
severe toxic effects that could be fatal. It is not surprising
that the investigation conducted by the state Department of
Health and UNICEF revealed that in of the case death was due
to causes unrelated to vitamin A. These were cardiac failure,
severe anemia, high fever, foreign body aspiration etc. Considering
the current mortality rate of 28/1000 in children aged 1-4 years,
15 deaths reported in the week following vitamin A administration
are far less that the expected number.
Inadequate training of health workers,
lack of supervision and negligence of children who developed
symptoms might have contributed to the confusion. There are
important lessons to be learnt from this episode. A community
may loose faith in government - sponsored public health programmes
if adequate precautions are not observed. Major precautions
for vitamin A are avoiding massive doses in young infants and
ensuring that the dose limit is not exceeded and that the administration
is carried out by trained health workers under strict supervision.
Adequate steps should be taken to educate the community about
the benefits of vitamin A supplementation and the possibility
of transient side effects. Extra precautions are needed for
treating sick children. WHO has recommended that sick children
who are at greater risk, particularly those with measles and
severe protein-energy malnutrition should be given an additional
dose of vitamin A. However this approach can create problems
if adequate precautions are not taken. If a child who is seriously
ill dies after receiving the dose, vitamin A may be blamed as
the cause of death ( as it happened in Assam). Such cases should
be referred to the nearest health centre for full treatment.
Efficient management is crucial for success of any public health
program.
Conclusion
VAD still exists as a public health
problem in many parts of India and there is a need for continued
efforts to improve vitamin A status of the population. It is
unfortunate that the Assam episode led to so much controversy,
putting an end to the vitamin A campaign even in other states.
However, this should be viewed not as a set-back, but as an
opportunity to strengthen the ongoing programme of supplementation
linked with routine immunisation and accord higher priority
to dietary approaches as a long-term sustainable solution.
Reference: SIGHT AND LIFE NEWSLETTER 3/2002.
