PHA-Exchange> Fwd: Meeting on 3/3/06 on Hepatitis B at WHO office Nirman Bhawan, New Delhi
Gopal Dabade
drdabade at gmail.com
Sat Mar 4 01:40:39 PST 2006
Dear friends at PHM, Ravinarayan and Dr Ekbal,
Greetings from Drug Action Forum - Karnataka, India,
I am here with forwarding the letter, which contains the minutes of the
meeting held on, Friday, 3rd March 2006 sent by Dr Jacob Puliyel who along
with Dr Santosh Mittal and Dr Vibha attended the WHO - SEARO, Delhi meeting,
at the invitation of WHO. (Though I was invited for the meeting I could not
make it to Delhi, because of some personal prolems).
The meeting has made a good beginning and in a way is a success. Many thanks
to the PHM network.
I am deleighted that at the meeting WHO has agreed to look at the major
concerns of Universal Immunisation with hepatitis - B vaccine as expressed
by Drug Action Forum - Karnataka, Jana Swasthya Abhiyan and the People's
Health Movement. (Please go through the minutes of the meeting as detailed
below by Dr Jacob Puliyel and also the draft that we had sent to WHO - SEARO
before the meeting). Myself and Dr Jacob Puliyel would like to thank Dr
Ekbal, Dr Ravinarayan and the global office PHM for having supported with us
on this important public health issue. We are over whelmed by all your
support and we both feel that the success of the meeting was largely to all
your support.
Nevertheless I must add that we at Drug Action Forum - Karnataka and PHM
need to do a follow up on this issues that have been raised at the
meeting, for its logical conclusion. For which again we seek your support
and involvement. I also request you to circulate this letter to all those in
PHM concerned.
Thanking you all again.
Best wishes
From:-
Dr GOPAL DABADE,
President,
Drug Action Forum - Karnataka,
57, Tejaswinagar,
Dharwad 580 002.
INDIA
drdabade at gmail.com
Cell +91 (0)9448862270
---------- Forwarded message ----------
From: Puliyel <puliyel at gmail.com>
Date: Mar 4, 2006 12:29 AM
Subject: Meeting on 3/3/06 on Hepatitis B at WHO office Nirman Bhawan, New
Delhi
To: wiersmas at who.int, burgessc at whosea.org, alagvi at npsuindia.org,
thapaa at searo.who.int, sagarka at npsuindia.org, mittal santosh <
skmittal44 at yahoo.com>, to Down <vibha at cseindia.org>, Gopal Dabade <
drdabade at gmail.com>, leej at who.int
Dear All,
We thank all of you who attended today's meeting.
The full text of our submission that was presented at the meeting is
attached. I am sorry I did not have sufficient number of hard copies for
everyone at the meeting.
It was acknowledged at the meeting that there was literally no data
available from the GAVI funded, Hepatitis B Pilot study in India, to suggest
that the project was successful and for it to be scaled up as a national
program.
The GAVI pilot project has been in place for over 5 years in some places. It
was agreed that such a study must be undertaken now.
A well stratified sample of 10,000 children (under 5 years) would be studied
in 1 or 2 or 3 areas (10,000 per area studied) where the pilot study is
underway.
The following will be studied in all the children
1. HBsAg status
2. Vaccine induced antibody levels
3. Vaccination history to check if the were immunised at birth, or at 6
weeks, or not vaccinated.
The following inferences can be drawn
1. How effective is the pilot in terms of coverage?
2. What percentage got immunised at birth?
3. What is HBsAg status in, in under-fives, compared to what it was before
the pilot study started
4. What is HBsAg status of those vaccinated at birth, compared to those
vaccinated starting at 6 weeks and those not immunised.
The study would be done in 6 to 12 months.
Professor Mittal and I agreed to help with the design and execution of the
study.
----------------------------------------------------------------------------------------------
We insisted that, as the WHO was in agreement with us, that there was no
worth while data to suggest that the pilot project was a success the WHO
must in all fairness ask the Government not to scale up the program pending
the new study. In the end Dr Craig agreed to write to the Government
outlining the gaps in knowledge and about the new study to fill this gap
prior to scaling up - with a copy to us.
--------------------------------------------------------------------------------------------------
We had hoped to send transcripts of the recording of the morning meeting to
all who asked for it. Unfortunately most of us were speaking softly and none
of us used a mike system and so it is uncertain if the recording is
complete.All the same an effort is being made to get the transcript ready.
Please let us know if you want a copy. Copies of the tape can also be
provided on request
I have summarised the proceedings as I remember them (from my perceptions).
I will appreciate suggestions for correction to be sent by return email.
Thank you again
Sincerely
Jacob Puliyel
___________________________
Jacob M. Puliyel MD MRCP MPhil
Sara Varughese DO FRCS MSc(LSHTM)
eFax 00 44 7092-124285
Phone 00 91 11 2946388
00 91 9868035091
*Meeting with WHO on Hepatitis B immunization in India*
*3/3/06** Nirman Bhawan*
* *
Thank you for taking time to discuss this issue with us.
For the discussion to be meaningful we had outlined only 2 preconditions
1. That we limit discussion to evidence based literature and data and
not include personal opinions
2. That we are prepared for all our deliberations to be on record.
I am a paediatrician. We are a not anti-vaccinationists. We are not
anti-free market spokes persons. The WHO represents the biggest force for
public health in the world. We see ourselves as staunch supporters of that
noble cause
We are here today discussing Hepatitis B vaccine in India
The Government of India plans to include Hepatitis B in the UIP, to be given
starting at 6 weeks. This seems o defy logic.
1. The country cannot afford to protect large numbers in our
population against DPT. In many areas the coverage is less than 20%.
Hepatitis B is vastly more expensive
2. The plan to vaccinate against hepatitis B at 6 wks (after vertical
spread has already taken place) appears especially inexplicable.
The Indian Minister for Health says he is doing this on the advice of the
WHO (Press cutting already sent to WHO)
The WHO on its part says it "takes it's mandate and direction from member
states, including India"
Let us not waste time on these circular arguments.
You are experts on Hepatitis B delegated to allay our anxieties about the
program.
We are all aware of how data has been fudged in the past to make the case
for hepatitis B vaccination. Dr Mark Miller of the CDC and WHO calculated
250,000 people die of hepatitis B in India each year. We suspected that he
had simply projected mortality data available from Taiwanese males on the
population of India. We wrote to the journal Health Economics. Dr Miller
replied that he had used country specific data stratified by geographic area
and income group.
We wrote in the journal that Dr Miller must publish this model or retract
the paper. Dr Miller wrote he did not have a model as it was 'lost' but the
paper has not been retracted yet. (Health Economics 2004;13:1147-8)
An 'expert group' from India, The Association for Study of the Liver,
published a 'consensus statement' that made out the vaccine to be
cost-effective and sent off it's recommendation to the Government. (Indian J
of Gastroenterology 2000;19 (Supp3) C 54) However in the columns of the same
journal so many errors were pointed out that the corresponding author of the
consensus statement finally wrote that the cost calculations must be redone
by the 'experts' The retractions were not sent to the Government.
You can see our reason for distrust of 'expert opinions' and why we insist
that all the data presented is verifiable.
The questions before us are
1. Is there a need for the vaccine in India?
2. If so will the vaccination program be cost-effective?
3. Is it affordable and feasible?
A) To answer the questions we need to know what is the WHO projection of the
hepatitis B chronic carrier rate in India?
(What is the primary data used and from which regions. How is the national
projection made from this data)
The best data to date seems to be a systematic review that suggests that the
rate is less than 2% (Lodha R et al Hepatitis B in India Ind Ped
2001;38:349-71)
B) How many people die of Hepatocellular carcinoma, cirrhosis and acute
liver failure due to hepatitis B each year?
The data from the Indian Council of Medical Research says it is 5000 in the
population of 1 billion.
Your letter says 25% will die prematurely. This is a throw back of the Dr
Mark Miller argument. The term 'prematurely' is meaningless in this context.
At what age do they die of HCC? Life expectancy in India is 63 years.
Perhaps shows that people die of other natural causes before HCC sets in. Is
it worth vaccinating this population?
C) The letter from the WHO says that the decision to include the birth dose
should be made by the country itself taking into consideration it's own data
on perinatal transmission.
In India the decision to vaccinate after 6 weeks, is not based on data on
'absence of perinatal spread' but on the fact that it cannot afford
immunisation at birth.
As experts do you think India does not have a problem of perinatal spread
that it does not need the dose at birth?
Our research suggests that 50% of chronic carriers acquire it vertically.
Nayak NC et al (`J Med Virol 1987;21:137-45) that the pattern of spread in
India is that in Africa where a third get it vertically from mothers and the
remaining get it from those who got it vertically. For this reason
prevention of vertical spread is crucial where the overall coverage is going
to be low.
Much is being made of the funds available through GAVI to help the
vaccination programme. The answers to parliamentary questions (which are in
the appendix below) is revealing. The pilot study costing Rs 270 million was
done with GAVI funds. They supplied self destroying syringes.
The program of universal immunization will cost Rs 5250 million every year
and will have to be continued indefinitely. No fancy self destruct syringes
this time around. The vaccine will be given with re-useable needles after
boiling. The number of children who get hepatitis B, HIV and other
infections because of this mass immunization program with unsterile needles,
will make the subject of an interesting study.
GAVI funded this study and it was a success we are told.
· What is the measure of success of the program?
· What is the carrier rate among babies under 2 years in cities where
the pilot was done compared to the carrier rate before the introduction of
this prophylaxis? That would be very useful to know – to prove that the
birth dose is not needed
There is no data
· What is the carrier rate in those who are immunized compared to
those not immunized.
Except for data from tribals in Andamans ( Murhekar MV Vaccine
2004;23:399-403) there is no data
· What is the uptake of vaccine in the pilot project areas.
We have one study from East Delhi that says that the coverage with hepatitis
B was 14% - only marginally more than the baseline 9% before the vaccine was
made available free of cost by the GAVI (Sokhey J et all J Trop Ped
2001;47:199-203) Another study from Delhi found coverage of 19 to
21.6%(Dasgupta R Health Policy Planning 2002;17;99-105
Is this true scientific rigor?
When GAVI started the pilot project what did it set out to test?
We know 270 million rupees have been spent. Is this the mark of success.
We know that 'n' number of doses have been consumed. Is that the hallmark?
· If we do not know how many people die of HCC and cirrhosis due to
Hepatitis B we do not know how many will be saved by the vaccine
· If we do not know how many are infected vertically, we cannot know
how many will benefit in spite of missing the birth dose
· If we are not able to get DPT vaccine (that costs pennies) to large
masses of our population how do we imagine we will do better with Hepatitis
B
There has been a sea change in what the WHO perceives as its public health
role in recent years. A statement of how the vaccine came to be recommended
in 1992 is not much relevant anymore.
*For **India**, this will arguably be the most expensive intervention ever
undertaken to save 5000 lives a year. We expect that the WHO experts will
have figures and data pertinent for different regions in **India** to show
that the programme they are encouraging, is cost beneficial for the
country. If it does not have such data, can we hope that the WHO will
advise the Government of **India** to hold the programme in abeyance till
the data is available. It owes this not to a resource poor nation like **
India** but to its own credibility.*
Dr Gopal Dabade,
President,
Drug Action Forum - Karnataka
drdabade at gmail.com
and
Jacob M. Puliyel,
Department of Pediatrics
St Stephens Hospital
Tis Hazari, Delhi 110054
Puliyel at vsnl.com,
Mobile 0091 9868035091,
Fax 00 44 7092-124285
Appendix
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
RAJYA SABHA
UNSTARRED QUESTION NO 3428
INCLUSION OF HEPATITIS B VACCINE IN THE NATIONAL IMMUNISATION PROGRAMME .
3428.
DR. D. MASTHAN
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-
(a) how many people/children have died due to Hepatitis-B virus during the
last three years in the country;
(b) whether Government will include Hepatitis-B vaccine in the National
Immunisation Programme to eradicate this killer virus; and
(c) if answer to part
(b) of the question be in the negative, the reasons therefor? ANSWER
ANSWER
MINISTER OF STATE OF THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI DALIT
EZHILMALAI)
(a) No authentic data is available of the number of the deaths caused by
Hepatitis-B infection alone. However, according to available data, the
number of cases of viral Hepatitis (all types) during 1995 to 1997
(provisional) is as follows:-
______________________________________________________________________________________________
Year No. of Persons infected No. of persons died
_______________________________________________________________________________________________
1995 98943
943
1996 117954
801
1997 89038
962
_______________________________________________________________________________________________
(b) and (c) Hepatitis B vaccination has not been included under the National
Immunization
Programme as the estimated cost will be around Rs. 525 crores per annum and
the measure if
initiated will have to be continued indefinitely to cover all children born
in the country
with 3 doses. Availability of funds to sustain this over such a long period
cannot be assured.
In order to reduce the risk, however State Governments have been advised to
provide vaccination
to the concerned hospital workers.
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
MINISTRY OF 29
RAJYA SABHA
STARRED QUESTION NO 408
CHEAPER HEPATITIS B VACCINE .
408.
SHRI BHAGATRAM MANHAR
RAJU PARMAR
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-
(a) whether it is a fact that Hepatitis-B spreads very easily and one in
every twenty Indians is already infected with this killer disease;
(b) if so, the steps Government have taken or propose to take for protection
against this disease;
(c) whether cheap vaccines are available in the country for the poor; and
(d) if not, the steps being taken to procure Hepatitis-B vaccines at cheaper
rates?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A.
RAJA)
(a) to (d): A statement is laid on the table of the House.
STATEMENT REFERRED TO IN REPLY TO RAJYA SABHA STARRED QUESTION NO. 408 FOR
12.8.2002 ....
Hepatitis-B spreads through unsafe sex, unsafe blood transfusion, unsafe
injections etc. and also from mother to child. Hepatitis-B is preventable by
ensuring precautionary measures. Studies undertaken so far, indicate that
about 3% to 5% of the population in the country is suffering from
Hepatitis-B infection. The following measures have been taken to prevent
infection of Hepatitis-B :- Central Government hospitals personnel at high
risk are being immunized against Hepatitis-B. State Governments have also
been advised to take similar steps. Guidelines have been issued for
mandatory testing of blood in all blood banks. Promotion of safe sex under
National AIDS Control Programme is advocated. Health awareness campaigns
regarding the danger of using unsterile syringes and needles under National
AIDS Control Programme are held. Guidelines have been issued to State Health
Authorities for use of separate sterile syringes and needles for each
injection. A pilot project to introduce Hepatitis-B Vaccine in 15 selected
cities and 32 districts in 17 States of the country, which are high risk
areas, in order to study the impact of administration has been launched. The
pilot project is estimated to cost Rs.27.19 crores out of which vaccines and
AD syringes cost Rs.23.89 crores, which will be funded by the Global
Alliance on Vaccines and Immunization (GAVI).
Vaccines for Hepatitis-B is available in the country at affordable prices
--
Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
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