E-drug: Letter to Health Minister, India re Hep B vaccination
---------------------------------------------
30th September 2005
To,
The Minister,
Ministry of Health & Family Welfare,
Government of India,
Nirman Bhavan,
New Delhi 110 011.
E-mail:- hfm@alpha.nic.in. Fax number 011-23062358.
Dear Minister,
This is in response to your press
statement in The Times of India, dated 6th September
2005, that hepatitis B vaccination 'will now be
administered in combination with DTPs to all children
on their 4th, 6th and 12th week from 2006. We have
been carrying out clinical trials of this combination
across 15 cities and 32 districts and it has proved
highly effective. The problem has become bigger than
even AIDS'.
We are surprised by this statement attributed to you
for the following reasons;-
1. We have previously enquired within Health Ministry
and know that no study was undertaken to look at the
effectiveness of the programme. The only measure we
have is an estimate of the number of doses used. Under
these circumstances it would be misleading to say the
'vaccine has proved highly effective'.
2. The Times of India dated 6th September 2005 further
states that according to Health Ministry records 'this
deadly virus which is the cause of 80% of all liver
cancer cases and about 1% of all deaths'. (This is
approximately 250,000). The actual number of deaths is
only 5,000 according to the Indian Council of Medical
Research. The author of the 250,000 figure is Dr
Miller from Centre for Communicable Diseases in
Atlanta and the figure was published in the journal,
Health Economics. Recently the same journal published
a demand for Dr Miller to retract his estimate for
India and Dr Miller has written in the journal that he
does not have the model used for India!
3. The Health Ministry statements create a ridiculous
impression that hepatitis B is more important than
AIDS. Hepatitis B infection spreads via the same route
as AIDS and much more rapidly and easily. But the
similarity ends there. Untreated HIV infection is 100%
fatal; in the case of hepatitis B infection 90% of the
adults who get infected eliminate the virus within six
months, though amongst infected infants, only 10%
eliminate the virus. Even amongst, these chronic
carriers (those who cannot eliminate the virus) the
average fatality rate is around 5% and not 25% as has
been claimed.
4. Newborns that get hepatitis B infection at birth
from their hepatitis B positive mothers have the
highest risk of acquiring HBeAg (hepatitis B e
antigen) infection. This HBeAg is the most infectious
variety of hepatitis B infection and has the highest
chances of becoming carriers. Prevention of this
perinatal (vertical) transmission from hepatitis-B
positive mothers requires that newborns at risk be
given the first dose of the vaccine within 12 hours of
birth. Hence the World Health Organisation (WHO) and
the American Academy of Pediatrics have recommended
that for such newborns, the first dose of hepatitis B
vaccine must be given not later than 48 hours after
birth. In India, since 77% births take place at home.
So the first dose of hepatitis B vaccine cannot be
given immediately after birth but only at 4th or 6th
weeks after birth along with the first dose of the
triple vaccine in the National Programme. Hence in
this programme 77% of the newborns will not be protected from the mother-
to-child mode of infection, which is the most
dangerous type of infection.
5. The claim that 4.7% of the Indian population is
chronically infected with hepatitis B virus is gross
overestimation based on a paper, which has
surprisingly made an elementary arithmetical mistake
and also has unscientifically assumed that all those
who are found to be positive for hepatitis B infection
are chronic carriers of this infection. Using the same
data correctly the actual hepatitis B carrier rate
works out to be only 1.42%. The WHO has recommends
hepatitis-B vaccination of all newborns only for
countries where this carrier rate is more than 2%. It
would be sensible to give the hepatitis B vaccine to
those who are especially prone to hepatitis B
infection. These include - medical professionals
coming in close contact with blood, patients in need
of dialysis/repeated blood transfusion, persons
exposed to unsafe sexual relations and newborns of
hepatitis B positive mothers. There is also a need to
vaccinate with hepatitis B all susceptible health care
workers by employers at no cost to employees.
6. With 25 million babies being born every year in
India, even assuming that the cost of hepatitis B
vaccine per child in this programme to be only Rupees
50/- (i.e. much less than the current price), it would
cost Rupees 125 crores annually for the vaccine only.
This is equal to our budget for Tuberculosis control
programme (the number one killer of Indian adults) and
is almost equal to the combined cost of other six
vaccines given to infants. Thus the cost-efficacy of
this programme is also unfavourable about Rupees 700
per life year saved compared to around Rupees 20 per
life year saved for the measles vaccination.
7. If at all hepatitis B vaccination programme is to
be undertaken, then the Selective Vaccination Strategy
should be used as has been done in other low
prevalence countries like Japan, United Kingdom and
the Netherlands. This strategy consists of identifying
the hepatitis B positive mothers through blood test
during pregnancy and vaccinating the newborns within
48 hours of birth. In India, about 3% of the newborns
are found to be positive. This Selective Vaccinating
Strategy would protect about 40% of the newborns from
the risk of highly infectious and damaging type of
hepatitis B infection, by vaccinating only 3% of the
newborns and would cost only one fourth of the
Universal Strategy. However this highly cost-effective
Selective Vaccination Strategy will not be very
effective unless the services for pregnant women
substantially improved from 65% to 90-100%. Secondly,
it will not eradicate hepatitis B infection. But even
if all newborns are vaccinated in the Universal
Vaccination Programme, with hepatitis B vaccine, then
it will take at least 65 years to eradicate hepatitis
B infection from India.
In a country where in many places only 20% of infants
get 3 doses of DPT and where the problems of supply of
clean water is yet to be addressed, it would be sad to
start this programme under pressure from the vaccine lobby.
In view of the serious and substantial
issues mentioned above, we request you (a) to stall
your decision to include the hepatitis B vaccination
in the National Immunization Programme, (b) invite us
for a detailed discussion with the concerned
officials/experts in your Ministry and (c) initiate a
public debate on this issue before taking a final
decision.
1. Sincerely yours,
Dr D Banerji, Professor Emeritus, Centre of Social
Medicine and Community Health, JNU, New Delhi.
nhpp@touchtelindia.net
2. Dr.B.Ekbal, National Convenor, JSA, State Committee Member, KSSP. ekbalb@gmail.com
3. Dr Gopal Dabade, President, DAF-K, Dharwad
dabade_pal@yahoo.com
4. Dr Jacob Puliyel, Head of department, Dept of
Paediatrics, St Stephens Hospital, Tis Hazari, New Delhi. puliyel@gmail.com
5. Dr Ananth Phadke, MFC, Pune.
amol_p@vsnl.com
6. Dr Pawar S L, Jt Secretary, DAF-K. Ranebennur.
drpawar@sancharnet.in
7. Ms Sharada Gopal. Jagruti, Dharwad.
drdabade@sancharnet.in
8. Dr Vandana Prasad, Pediatrician, New Delhi.
chaukhat@yahoo.com
9. Dr. Amita Pitre, CEHAT, Mumbai. ampitre@yahoo.com
10. Dr Saumya Panda
psaumya@vsnl.net
11. Dr Vijay Kanhere, Occupational Health and Safety
Centre. sujvij@vsnl.com.
12. Dr Ananth Bhan, dranantbhan@yahoo.com
Copy to;-
1) Dr P Haldar, Assistant Commissioner (UIP),
Department of Family Welfare, New- Delhi.
2) Dr Raju C Shah, President, Indian Academy of
Paediatrics, Ankur children hospital, Sharada near
Dipali cinema, Ashram road, Navrangura, Ahmedabad