PIL about Vaccine: Rejoinder to reply by ICMR
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
Writ Petition (Civil) No. 13698 Of 2009
PUBLIC INTEREST LITIGATION
IN THE MATTER OF:
DR. K. B. SAXENA & ORS. …PETITIONERS
VERSUS
UNION OF INDIA & ORS. …RESPONDENTS
REJOINDER AFFIDAVIT ON BEHALF OF THE PETITIONERS TO THE COUNTER-AFFIDAVIT OF RESPONDENT NO. 3 (ICMR)
I, Dr. Jacob M Puliyel S/o Late Shri P. M. Mammen Head, Dept. of Pediatrics, St. Stephans Hospital, Tis Hazari, New Delhi-110054, do hereby solemnly state and affirm as under:
1. That I am the Petitioner No. 8 in the above writ petition and I have also been authorized by other Petitioners to file this affidavit on their behalf. I, being conversant with the facts and circumstances of the above writ petition, am competent to swear this affidavit.
2. That I have gone through the Counter Affidavit of Indian Council of Medical Research/Respondent No. 3 (hereinafter the ICMR) and submit my reply as given below. Petitioners crave leave of this Hon’ble court to not to give a para-wise reply.
3. It is at the outset humbly submitted that ICMR has filed a vague 5 page affidavit which does not contain any scientific data or any annexures. It is not well drafted either, perhaps deliberately so.
4. The Petitioners had filed the above writ petition highlighting how irrational vaccines are sought to be introduced into the national immunization programme without proper epidemiological studies. The Petitioners showed that how vaccines which are of questionable utility, expensive and also carry possible side-effects are sought to be introduced at the cost of public exchequer at the behest of WHO and vaccine manufacturers. It was shown that all this is happening because India does not have a policy for vaccine evaluation and that is why the petition had sought a direction from this Hon’ble court to the Government to formulate a rule-based vaccine policy incorporating the principles of scientific assessment and transparency, as has been done by other countries.
5. ICMR has now filed its reply. In their counter-affidavit, ICMR has stated that it was aware of the multicenter study done by ICMR itself on the need for Hib vaccine in India. This begs the question of why the data from the study on pneumonia incidence and deaths was not included in the NTAGI report. Selective quoting of the literature is an antithetical to the principles of evidence based medicine and cannot be accepted from an “expert” advisory body to the Government.
6. Furthermore at the meeting held under the chairmanship of the health secretary the chairperson of the NTAGI sub-committee was asked in the presence of the health secretary why this data was not included. J P Muliyil, CMC Vellore - Chairperson; Jacob John, Vellore – Co-Chair NTAGI; and Dr Naveen Thacker, Indian Academy of Pediatircs representative to NTAGI; were present at this meeting and they admitted that this data was available to the committee.
7. The Petitioners had alleged that a pneumococcal vaccine covering 70% strains, that was not even manufactured, leave alone tested, had been recommended to be introduced in 2010 by NTAGI. These shocking facts have been confirmed by the ICMR affidavit.
8. ICMR states that the letter quoted in the petition was a letter by one of the petitioners published in an indexed medical journal and it was published after the NTAGI meeting. The letter does not pertain to any new facts but is data taken from the article by Minz. It is surprising that the expert body could not make the simple deduction made in the letter from the article by Minz. The data on diabetes and Hib strain replacement were all available well before the HTAGI but are not referred to in the section on safety.
9. ICMR correctly states that Cochrane review (a comprehensive analysis) came after the NTAGI sub-committee meeting. But it came much before the NTAGI recommendation was submitted and NTAGI made no effort to review its recommendation.
10. In Canada, Hib vaccine has nearly eliminated H influenza B bacteria but it has replaced it with another H influenza strain which is even more difficult to treat. Studies on this are annexed and are marked as Annexure A (colly).
11. In the case of Pneumococcal vaccine, strain shifts are also there. The replaced bacteria are far more serious and cause 70% in pus infection of chest. A study on the same is annexed and is marked as Annexure B.
12. Two more studies have been accessed by the Petitioners which clearly show that Hib vaccine is causing Diabetes. The said studies are annexed and are marked as Annexure C and Annexure D.
13. In fact, Global Alliance for Vaccines and Immunization (GAVI), on whose partial funding Government has proposed to introduce Pentavalent vaccine has itself come under criticism that its policies are promoting inequality and are at the behest of vaccine manufacturers. Their recommendations are ill-suited for a developing country like India with very low immunization coverage which by Government’s own statistics is less than 50%. Two reports regarding GAVI on this issue are annexed and are marked as Annexure E (colly).
14. The intervention of the court and the work of public health specialists have induced the Government to reexamine the basis on which the National Technical Advisory Group on Immunization (NTAGI) made its recommendation to introduce Pentavalent vaccine. It has constituted an experts body that excludes outside influence of bodies like the World Health Organization (WHO). A copy of the letter of invite to a meeting for such review is annexed and is marked as Annexure F. News reports that introduction of Pentavalent vaccine has been stayed by the Government till the review are annexed and are marked as Annexure G (colly).
15. However again there is no transparency on how this body has been constituted and many credible experts have not been invited while many old NTAGI members have found a place in this committee also. This means that NTAGI members would not sit on review of their own recommendation. This also smacks of ad-hocism.
16. Thus the Government has conceded the demand to exclude outside agencies like the WHO, but the Petitioners fear it may only be window dressing to reassure the court. The major demand that such a body must be made up only of persons without conflict of interests and that the recommendation of the committee must be open to the public and scientific scrutiny have not yet been conceded.
17. Under these circumstances, Petitioners pray to this Hon’ble Court to stay the introduction of new vaccines till a scientific system of vaccine evaluation is evolved and a professional body of public health experts created for the purpose.
18. The Petitioner craves leave of this Hon’ble Court to add/amend to this rejoinder affidavit if required.
DEPONENT
VERIFICATION
I, the deponent above-named, do hereby verify that the contents of the above affidavit are true to my knowledge, no part of it is false and nothing material has been concealed therefrom.
Verified at New Delhi on 24th day of February 2010.
DEPONENT
Annexure 1
Mail Today
The 'false' pandemic: Drug firms cashed in on scare over swine flu, claims Euro health chief
Fiona Macrae
http://www.dailymail.co.uk/news/article-1242147/The-false-pandemic-Drug-firms-cashed-scare-swine-flu-claims-Euro-health-chief.html
Annexure 2
India asks WHO to explain swine flu alarm
Indo-Asian News Service
http://www.hindustantimes.com/India-asks-WHO-to-explain-swine-flu-alarm/Article1-499880.aspx
Annexure 3
Meeting of National Technical Advisory Group on Immunization
26th August 2010, R. No. 155A, Nirman Bhawan
Minutes of Meeting
Annexure 4
Inaccuracies in minutes
Jacob Puliyel
Head of Pediatrics
St Stephens Hospital
Tis Hazari
Delhi 110054
puliyel@gmail.com
Phone 9868035091
To
Ms Saumitra Sahar
Section Officer
Health and Family Welfare
Nirman Bhawan
New Delhi
Subject: Inaccuracies in Minutes circulated of the Technical Consultative meeting on Immunization on 14.12.2009
Dear Ms Sahar
Ref T-13011/47/2009-CC&V
I notice some inadvertent inaccuracies have crept into the minutes of this meeting. If these are not corrected they may be used to discredit all the contents of the minutes.
1. Para 5 Dr SK Mittal is described as a ‘former President –IAP’
Correction needed
Professor Mittal was Director Head of Pediatrics Maulana Azad Medical College and Chairperson of the IMA sub committee on Immunization.
He was never IAP President
2. Para 5 referring to my presentation it says:
Dr J Puliyel raising concerns about the technical basis of estimating the burden of disease for introduction of vaccines against Hepatitis B, Haemophilus influenza type b (Hib) and pneumococcal infective diseases----
Dr Naveen Thaker ex IAP President stated that there exists burden of above mentioned disease and that vaccines are the most cost effective way of reducing this burden questioning some of the assumptions drawn by J Puliyel.
Correction needed
I raised no concerns about the technical basis of estimating burden of disease.
I presented data from an ICMR study in Anaicut block obtained through a series of RTI.
I asked why the data was not included in the data reviewed by NTAGI sub committee recommending Hib.
I showed how the study found incidence of ‘all-cause pneumonia needing admission’ was 30/1000 and deaths were 0.3/1000.
The only assumption I made was to say that even if 10% cases of pneumonia were to die in ‘out of study’ circumstances (the observed mortality in the study was only 0.7% of cases), the mortality would be 3/1000 and this was much lower than the 14/1000 death from pneumonia projected for India.
In one stroke the study undercut one of the main planks for the demand for 2 vaccines – the Hib and the pneumococcal vaccines.
Prof Mulayalil Chairman of NTAGI sub committee admitted the data from this study had been reviewed by the sub-committee but it was kept out of the report.
Dr Thacker stated anecdotal evidence for the existence of Hib disease. The Health Secretary asked him if he had published studies to support his stand but he provided no further evidence.
Please arrange to show this letter to the Health Secretary Ms Sujatha Rao, and issue a corrected minutes if needed. In any case these objections may please be recorded.
Sincerely
Jacob Puliyel
Copy
Dr V M Katoch
Secretary
Dept of Health Research
ICMR
New Delhi
Annexure 5
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
LOK SABHA
UNSTARRED QUESTION NO 2548
ANSWERED ON 22.07.2009
INCLUSION OF NEW VACCINE UNDER NATIONAL IMMUNISATION PROGRAMME
2548 . SUPRIYA SULE
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-
(a) whether the Government has any plan to introduce Pentavalent Vaccine in the National Immunisation Programme;
(b) if so, whether this plan has already been cleared by the Ministry of Finance;
(c) if so, the details thereof;
(d) whether the Government is also negotiating with the World Bank to get some funds for the scheme; and
(e) if so, the time by when a final decision in this regard is likely to be taken and the aid likely to be received from the World Bank? ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a): Yes. Based on the recommendation of the National Technical Advisory Group on Immunization (NTAGI) , a decision has been taken to introduce Pentavalent combination vaccine of DPT-Hepatitis B-Hib (Haemophilus influenzae b) in five states, namely, Himachal Pradesh, Jammu and Kashmir, Karnataka, Kerala and Tamilnadu during 2009-10 to 2011-12
(b) & (c): Expenditure Finance Committee in its meeting on 9th June, 2009, has recommended the proposal with few observations; reply to these will be incorporated in the final ‘Note for Cabinet Committee on Economic Affairs’.
(d) & (e): Yes. A letter seeking funds from the World Bank was sent to the Department of Economic Affairs, Ministry of Finance, in June, 2008.
________________________________________
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GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
LOK SABHA
UNSTARRED QUESTION NO 440
ANSWERED ON 20.11.2009
IMMUNISATION OF CHILDREN
440 . SUPRIYA SULE
UDAY PRATAP SINGH
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:-
(a) whether most of the children in the country are not immunised;
(b) if so, whether in the absence of basic immunization of children, most of them run risk of disease even in the period of basic immunization schedule;
(c) if so, the facts thereof;
(d) whether the Union Government in consultation with the State Governments proposes to evolve policy to ensure that each and every child is immunized in the scheduled period itself; and
(e) if so, the details thereof? ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE(SHRI GHULAM NABI AZAD)
(a) to (c): As per the latest DLHS-3 survey in 2007-08, 54.1 % children (12-23 months) had received full immunization and only 11.3% children (12-23 months) were found to have had ‘No Immunization’.
The details of Vaccine Preventable Diseases (VPDs) as reported by the Central Bureau of Health Intelligence (CBHI) and the World Health Organization- National Polio Surveillance Project (WHO-NPSP) during 2006, 2007 and 2008 are at Annexure.
(d) & (e): Under the Universal Immunization Programme (UIP) of National Rural Health Mission (NRHM), immunization cards are issued to individual beneficiary at the time of birth/at first immunization and is monitored by the Health Worker during Village Health and Nutrition Days and during home visits, so as to ensure timely immunization.
Annexure 6
Clin Infect Dis. 2007 Jun 15;44(12):1611-4. Epub 2007 May 2.
Characterization of invasive Haemophilus influenzae disease in Manitoba, Canada, 2000-2006: invasive disease due to non-type b strains.
Tsang RS, Sill ML, Skinner SJ, Law DK, Zhou J, Wylie J.
Annexure 7
Child sacrifice for Bio-medical research in Bhutan and other countries Govinda Rizal 2010-01-17, Kyoto
http://www.redroom.com/articlestory/child-sacrifice-bio-medical-research
Annexure 8
Invasive Haemophilus influenzae disease in Manitoba in the post-vaccination era suggests a changing epidemiology. Can Commun Dis Rep. 2006 Jun 1;32(11):125-30.
Invasive Haemophilus influenzae disease caused by non-type b strains in Northwestern Ontario, Canada, 2002-2008.
Brown VM, Madden S, Kelly L, Jamieson FB, Tsang RS, Ulanova M. Clin Infect Dis. 2009 Oct 15;49(8):1240-3.
Empyema hospitalizations increased in US children despite pneumococcal conjugate vaccine.
Li ST, Tancredi DJ.
Pediatrics. 2010 Jan;125(1):26-33. Epub 2009 Nov 30
Vaccines and the risk of insulin-dependent diabetes (IDDM): potential mechanism of action.
Classen JB, Classen DC.
Med Hypotheses. 2001 Nov;57(5):532-8.
Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM.
Classen JB, Classen DC.
Autoimmunity. 2002 Jul;35(4):247-53.
BMJ 322 : 754 doi: 10.1136/bmj.322.7289.754/c (Published 31 March 2001)
News roundup [abridged versions appear in the paper journal]
Global vaccine initiative creates inequity, analysis concludes
Gavin Yamey
HAI Europe, 2001, Vol.6, No. 1
Immunisation for All? A critical look at the first GAVI partners meeting
by Anita Hardon
http://www.haiweb.org/pubs/hailights/mar2001/index.html
Concerns raised, five-in-one vaccine will have to wait
Teena Thacker
http://www.indianexpress.com/news/concerns-raised-fiveinone-vaccine-will-ha/578781/
Life-saving’ vaccine project on hold
Namita Kohli, Hindustan Times
New Delhi, February 14, 2010
http://www.hindustantimes.com/Life-saving-vaccine-project-on-hold/Article1-508638.aspx