Public Interest Petition (PIL) Vaccine case 6th affidavit 14/11/11
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
C.M. No. OF 2011
IN
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
APPLICATION FOR DIRECTION ON BEHALF OF THE PETITIONERS UNDER SECTION 151 CPC
To,
The Hon’ble Chief Justice of Delhi And
His Hon’ble Companion Justices of the Hon’ble High Court of Delhi
The humble application of the petitioners above named:
1. The Petitioners had filed the instant writ petition in public interest highlighting how irrational vaccines were being introduced in the public health system by the Government, under the influence of vaccine manufacturers and international agencies like World Health Organization (WHO), without proper epidemiological and medical studies. Petitioners (who are generally pro-vaccine and pro-modern medicine) were appalled at how in the absence of a rational vaccine policy, newer and newer vaccines were being pushed by the Government into the national immunization programme. Vaccines which are either of little utility or which are not required at all were being introduced and promoted by the Government at the behest of these vested interests and, at the same time, basic vaccines that are the right of every child are not being made available under the Universal Immunization Programme (UIP) to 53% of the population – mostly poor living in rural areas who should be the priority for any immunization program as the poor cannot afford the consequences of disease.
2. Though this petition caused a temporary halt to Government’s ill-conceived plans, yet now the Government is again pushing for the introduction of new vaccines, especially Pentavalent (5-in-one) vaccine. Pentavalent combines the essential EPI vaccines of DPT with non-EPI non-essential and expensive vaccines of Hib and Hepatitis B. Thus the new vaccines for which there is low demand and which are expensive, would piggy-bank on the essential DPT vaccine (which is of extremely low price). This will make the plain DPT vaccine unavailable and every child would have to take Pentavalent to get access to DPT. Introducing Pentavalent in the UIP would mean that UIP would have extremely low coverage and would cost tens of thousands of crores of public money. This is a giant scam in the making.
3. This is happening at a time when the Government has shut down virtually all public sector units that were supplying the essential vaccines at a cost that is a fraction of the cost at which same vaccines are produced by the private sector. There were no complaints against these units and the general view was that these units were doing exemplary work. No question was ever raised regarding the quality of vaccines produced in these centres. Yet, without any provocation they were closed down on the pretext that they were not following “good manufacturing practices” which related to their building set-up. Even if they required upgrade, government should have sanctioned some funds for the purpose. More and more information has come in the public domain to highlight how this was a systematic attempt to benefit private companies. Now, response under RTI has clearly shown that after the above public sector facilities were shut down, there has been a huge increase in the number of deaths of children due to vaccination side effects. RTI reply and reports on this are annexed as Annexure A1 (Colly). This shows how the Government played with the health of children just to benefit private companies. After the closure of public sector units became a big public scandal and this fact was highlighted in the instant petition, Government announced its decision to reopen the 3 vaccine manufacturing facilities. But the 3 units have still not been opened. A news report on this is annexed as Annexure A2.
4. National Technical Advisory Group on Immunization (NTAGI) is the apex advisory group on vaccination and immunization for Universal Immunization Programme (UIP). Petitioner No. 8 was inducted as a Member of the said group during the pendency of the instant petition. The proceedings and the minutes of NTAGI meeting exemplifies clearly the reasons for which the petitioners came to court – how irrational expensive vaccines are being introduced in the public health system by the Government, without proper epidemiological and medical studies in a country where needed inexpensive vaccines are being denied to 50% of the population. Decisions are made before-hand based on extraneous considerations. Data is provided only to give it a veneer of objectivity. When such data is shown to be wrong, other equally fanciful data is provided but the determination to introduce the vaccine persists. The NTAGI had previously recommended universal immunization with the Pentavalent vaccine. But then it was pointed out to this court that the data from a multi-center study done by the Government of India was deliberately left out because it did not support the need for the vaccine. After this, the Government set up an ‘Experts Group’ to look at this and followed it with a ‘Core Committee’ recommendation After all this, the NTAGI met on 26 August 2010. The NTAGI again recommended introduction of Hib and Hepatitis B vaccine in 2 states but now gave different reasons and quoted other data. The new ‘evidence’ is as fallacious as before and this has been clearly pointed out to the Government in a presentation to the Planning Commission. A copy of the presentation made to the Planning Commission is annexed as Annexure A3.
5. The numbers benefiting (deaths avoided by vaccination) from Hepatitis B was based on ‘personal communication’ from Prof Acharaya of AIIMS Dept of Gastroenterology. He claimed to have done liver biopsies on all Hepatitis B carrier patients going to AIIMS over one and a half years. Such an invasive and potentially lethal investigation on all patients would be gravely unethical and inconceivable. One can surmise that Dr Acharaya wanted to project the data of patients going to him in the Gastroenterology Unit on the whole population of India. It must be for this reason that he stated that liver biopsy was done in all patients (consecutive patients) going to AIIMS. The figure of 3 lakh cases of cirrhosis a year in the country is based on this fiction. Other than this, the only other data on deaths averted nationally by Hepatitis vaccination that is presented is ‘22238 cases of Hepatocellular Carcinoma from the ICMR cancer registry’. Here again the figure has been exaggerated by over 200%. The correct figure from the ICMR cancer registry is about 10,000.
6. In the same way the recommendation for Hib vaccine was made on the projection that 52000 cases of Hib meningitis occur in the country each year. The projection for the whole country is made from 9 cases of ‘presumed Hib meningitis’ in one year, in one district in Kerala. The same paper that reported 9 ‘presumed Hib’ also reported there were only 3 cases of presumed Hib in that district, in the next year. No explanation is given of why this figure of 3 cases was not used for making national predictions. Selective use of data flies in the face of the basic tenets of ‘Evidence Based Medicine’. The numbers needed to vaccinate to prevent one death is crucial to make informed decisions on the cost benefit of introducing a new vaccine. The fanciful figures that were used in the ‘expert committees recommendation’ and the NTAGI recommendation, supports the contention of the petitioners that the vaccine is being introduced at the behest of various vested interests without clear evidence that it will be useful or that it is needed.
7. The petitioners had drawn attention of this Hon’ble court to the deaths from Pentavalent vaccine in Sri Lanka. The Government provided the Court with a report about these deaths to say that deaths were investigated and were found not to be related to the vaccine. Petitioners had highlighted how the standard classifications of adverse effects were changed so that reactions which should have been classified as ‘probably related’ were classified as ‘unlikely’. To enable them to do it the ‘experts’ temporarily deleted the category ‘probably related’ from the classification itself for use in this report. WHO has now stated that it still stands by its full standard classification and does not use the mutilated format for reporting adverse effects. A report on this is annexed as Annexure A4. The draft policy, that was submitted to this Hon’ble Court by the Government, on the other hand uses the watered down, mutilated version; as if serious side effects and deaths from the vaccine are not of any importance to this government. Concerns were raised on the above issues in a special mention in the Rajya Sabha on 12.08.2011. A copy of the special mention made in Rajya Sabha on Pentavalent vaccine is annexed as Annexure A5.
8. The National Technical Advisory Group on Immunization (NTAGI) noted that the utility of the two new components of the Pentavalent vaccine (Hib and Hepatitis B) is not known in India. Furthermore there have been deaths with the use of this combination vaccine in neighboring countries Sri Lanka, Bhutan and Pakistan. The cost of the standard DPT vaccine will go up 10 fold with this vaccine. 50% of India’s children already do not receive the inexpensive DPT. However, NTAGI inexplicably still recommended that the vaccine be tried in 2 states – in Kerala and Tamil Nadu to evaluate the impact and side effects before introduction in other states. There is considerable disquiet in the 2 states at being selected as guinea pigs for this experiment. Special mention was made of this in the Rajya Sabha. Tremendous international pressure is being brought to bear on India to introduce the expensive Pentavalent vaccine in India. This was also the agenda of a meeting of WHO, pharmaceutical companies and Bill Gates Fund in Delhi on 2 August 2011. Although the NTAGI recommended introducing the vaccine in 2 states to study its adverse effects and benefits, and the programme is said to be on the verge of being rolled out, no mechanism has been put in place check with recipients of the vaccine after a week about the side effects or to study objectively if there is any benefits.
9. The entire exercise is reminiscent of the HPV study by PATH where the Expert committee found that 4 of the 5 objectives were to study safety of the vaccine but no diary or log of adverse effects was maintained. The Government cannot be allowed a repetition of that situation. Wherever study of efficacy, adverse affects and general safety of a drug or vaccine is conducted, it is always done in a small district and the after-effects of that drug or vaccine are surveyed, house to house. Studying the after-effects of a vaccine would require frequent follow-up visits of all the children, which is impossible if the vaccine is introduced in the whole state. By introducing the Pentavalent in the entire states of Tamil Nadu and Kerala, the Government is not only allowing the pharma companies to make huge profits, but also leaving no scope for study of affects of the vaccine. Thus, only if newspapers break news of serious adverse effects and it becomes a public scandal, then and only then, would the Government reluctantly state that trial did not prove efficacy and safety of the vaccine. There have been protests in the above states by people stating that they are being used a guinea pigs. This unethical trial of Pentavalent in the 2 states without any monitoring of its aftereffects has met stiff resistance from the local populations. Reports on this are annexed as Annexure A6 (Colly).
10. The procedure of selection to NTAGI and the processes followed at the meeting was witnessed by Dr. Puliyel (Petitioner No. 8) who was inducted into the NTAGI without any examination of his credentials - perhaps on the basis of the fact that he is a petitioner in this case. A request by Dr. Puliyel to have the proceedings recorded, so that members can be held accountable for what they say, was denied on the grounds that members would not voice their views freely, if it were recorded. No explanation was given why members on a vaccine advisory group may need secrecy for the recommendations they make. The wisdom of denying the request of recording was plain when the minutes of the meeting were circulated. The minutes are manipulated to selectively quote members statements as consensus statements.
11. This Hon’ble Court had asked the Government to frame an appropriate policy for vaccination and immunization. Pursuant to the orders of this Hon’ble Court, NTAGI resolved that Dr. Puliyel would help Dr N K Ganguly to draft the Vaccine Policy. This was recorded as such in the first draft of the minutes circulated to members and attached. The name of Dr. Puliyel was removed in the final version of the minutes in blatant violation of the expressed wishes of the NTAGI. A copy of the letter written by Dr. Puliyel protesting against the removal of his name is annexed as Annexure A7.
12. After this manipulation, a draft policy was prepared by Dr. Ganguly that was submitted to this Hon’ble Court by the Government. A copy of his response of the Dr. Puliyel to the above draft policy is annexed as Annexure A8. According to a story published in CSE’s Down to Earth the draft policy backed new expensive vaccines without study. A copy of the said article is annexed as Annexure A9. This shows that right from the very beginning there were systematic attempts to push newer expensive vaccines under corporate pressures.
13. Now Dr. Ganguly has on his own drafted a vaccine policy. There are serious issues that the petitioners have with this policy which defeats the objective with which petitioners had approached this Hon’ble Court. The policy document states it will be “mandatory for the government to support advance market commitments and honor the commitments”. Advance market commitments (AMC) are made even before the prototype of the vaccine is produced. The commitments are made before the vaccine is tested for its efficacy/effectiveness in the local population. A copy of the said policy drafted on the directions of this Hon’ble Court is annexed as Annexure A10.
14. The policy goes further to suggests the government use ‘innovative finance mechanisms’ (GAVI terminology that means the Government must take loans by the issue of bonds) to pay the World Bank in advance. By including the line making AMC mandatory on all future Governments, the authors of this policy propose to bind the hands of all future governments.
15. In an interview to Centre for Science and Environment (CSE)’s fortnightly magazine Down to Earth, author of the policy, Dr. Ganguly says “The government will commit to the manufacturers so that they invest in vaccine production. If governments do not commit, the company which will set up the plant exclusively for the need of the country, may sink because no one else would want that vaccine and the company would be producing it exclusively for the country which demanded it…” This statement is self-explanatory. In the same article he also says that, “…One contract will last for a year for one programme. Once the programme is over, the government will revise the programme and select new companies. If the government wants to discontinue a particular vaccine after a year, it can easily do that…” The above statements contradict each other. While in the first he is worried about the vaccine companies, in the second he withdraws from this, knowing that the former position cannot be defended even to a press reporter. This clearly shows that the policy is made in the interest of and at the behest of private pharmaceutical companies. A copy of the said story titled ‘Experts contest new vaccine policy document’ is annexed as Annexure A11. National daily ‘Mail Today’ has done a story highlighting how the vaccine policy has come under criticism for favouring manufacturers and not the general public. A copy of the said story is annexed as Annexure A12.
16. According to the above article in Down to Earth, this policy was approved by UN agencies. On the other hand there was no open consultation with experts in India nor was the Indian public taken into confidence. A recent publication authored by 8 international experts on behalf of 140 organizations of the world has drawn attention to the fact that UN is playing into the hands of all kinds of industry with huge conflicts of interests. A copy of the said article published in ‘The Lancet’ is annexed as Annexure A13. The swine-flu vaccine scam is too well known where swine-flu was declared as a pandemic by the WHO which turned out to be a false-alarm that only benefited vaccine manufacturers. Reports on this are annexed as Annexure A14 (Colly). A letter written by prominent political leader Ms. Brinda Karat who has been closely monitoring the HPV vaccine trials, to the Health Minister highlights the unethical practices by WHO in developing countries. A copy of the said letter dated 27.10.2011 is annexed as Annexure A15. An editorial published in The Hindu called the said trial as “shockingly unethical”. A copy of the said editorial is annexed as Annexure A16. Newspaper The Tribune has also written a detailed report highlighting the serious lapses in the HPV vaccine trial. A copy of the report published in The Tribune dated 09.05.2011 is annexed as Annexure A17. There have been several other reports on the way trials are conducted in India and the way vaccines are being pushed onto Indian children. The said reports are annexed as Annexure A18 (Colly). The Government of India has now admitted lapses in the HPV vaccine trial. A copy of the report on this is annexed as Annexure A19. This has also exposed the dubious designs of international donor organizations as stated above.
17. Dr. Puliyel, Member NTAGI has registered his strong protest at the final version of the policy. In a latter to the Health Secretary who is also the Chairperson NTAGI he has stated: “The vaccine policy ideally would state how the government proposes to universalize the benefits of immunization to the large sections who don’t receive the basic vaccinations. It would also describe how new vaccines are to be selected for introduction in the programme for universal immunization. Ideally it would lay down the process of selection of members to the NTAGI and how the procedures of this committee are to be recorded and made open to the public. Methods of estimating disease burden, vaccine efficacy, and assessment of costs, benefits and adverse effects of newer vaccines; and the process of how new vaccines are to be introduced, should have found a place in the policy. Unfortunately the draft is non committal on almost all of these issues.” A copy of his letter is annexed as Annexure A20. EPW has also published a detailed article against the new vaccine policy stating that it puts the interest of industry over the public health. A copy of the said article dated 05.11.2011 is annexed as Annexure A21.
18. Earlier, in response to our petition Government has stated that it would conduct trials in 2 states of India: Tamil Nadu and Kerala, to determine the efficacy and the need of Pentavalent vaccine. It is now clear that this push was made for eventual introduction of Pentavalent in the country’s UIP at the behest of international agencies like UN and Bill Gates Fund. There is now ample evidence to show that vaccination policies and funding is being driven on the basis of industrial pressures and misplaced priorities. Studies and reports on this are annexed as Annexure A22 (Colly). Now there is clear evidence that cost of pneumococcal vaccine was underestimated by 10 times. A published letter of Dr. Puliyel is annexed as Annexure A23. Now, even the WHO has been forced to accede to concerns of doctors that there is not adequate data to push for Hepatitis B vaccine. A report on this is annexed as Annexure A24.
19. In the face of the above facts, the vaccine policy prepared on the directions of this Hon’ble Court does not address the concerns of millions of children who have been left out from receiving even basic essential vaccination and instead tries to protect the vested interest of vaccine manufacturers, it violates Article 14 and Article 21 of the Constitution and therefore deserves to be set-aside by this Hon’ble Court. The said policy has been made without any transparency, without even the pretence of public consultations, has not been approved by NTAGI, does not have approval of Union Cabinet or of the Parliament, and yet it tries to steer the country’s immunization programme in the wrong direction, tries to make commitments of thousands of crores of rupees binding future governments, into purchase of newer expensive vaccines whose prototype has not even been modeled alone tested, from foreign private companies. Such a policy is therefore void ab initio.
20. There is no transparent method to select members to the NTAGI. As such, the government does not get independent advice but it merely hears what it wants according to the persons that they have appointed to the committee. It is clear that there needs to be an open and transparent selection process for appointing members to this advisory body. The Government may appoint an expert committee to select the best persons from among applicants for the job in a transparent manner. The duration of the appointment must be fixed, and to ensure organizational memory, only a part of the committee must retire each year. The discussions in the NTAGI meetings must be open to the public so that each member is accountable for the advice they proffer. Only this can ensure that public health policies are not hijacked by vested interests in the future.
21. That the present Application is being made bona fide and in the interest of justice.
PRAYERS
In these circumstances the Petitioners pray that your Lordships may be pleased to pass following ad-interim directions:
(i) Set aside the vaccine policy (Annexure A10) and direct the Government to set up a committee to transparently select members of NTAGI for a fixed term from credible public health experts and pediatricians with no conflict of interest, to formulate new vaccine policy and study the effects of introduction of Pentavalent in the 2 states
(ii) Pass further orders as may be deemed fit and proper.
AND FOR THIS ACT OF KINDNESS THE APPLICANTS AS IN DUTY BOUND SHALL EVER PRAY
Petitioners
Through: PRASHANT BHUSHAN
Counsel for the Petitioners
Filed on: November 2011
New Delhi
IN THE HIGH COURT OF DELHI AT NEW DELHI
(CIVIL ORIGINAL JURISDICTION)
C.M. No. OF 2011
IN
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
INDEX
S. NO PARTICULARS
PAGE NO. C.FEE
1 Urgent Application
2 Application for Direction on behalf of the Petitioners under section 151 CPC with Affidavit
3 Annexure A1 (Colly): RTI response and reports on number of deaths due to vaccination side-effects
4 Annexure A2: News report showing that 3 public sector units are still shut
5 Annexure A3: Copy of presentation made to Planning Commission on immunization
6 Annexure A4: Report on WHO standing by its classification on vaccine deaths/adverse affects
http://blogs.timesofindia.indiatimes.com/staying-alive/entry/26-measles-vaccine-deaths-in-3-years-no-investigative-report-yet1 http://blogs.timesofindia.indiatimes.com/News-sick/entry/investigating-vaccine-deaths-to-be-managed-primarily-by-national-government-who
7 Annexure A5: Special mention in Rajya Sabha on Pentavalent on 12.08.2011
8 Annexure A6 (Colly): Reports on the trial of Pentavalent in Tamil Nadu and Kerala
9 Annexure A7: Copy of letter written by Dr. Jacob Puliyel, Member NTAGI
See below
10 Annexure A8: Copy of the response of Dr. Puliyel to draft vaccine policy
See below
11 Annexure A9: CSE’s report on draft policy pushing for new expensive vaccines
http://www.downtoearth.org.in/content/policy-draft-backs-new-vaccines
12 Annexure A10: Copy of vaccine policy made pursuant to the directions of this Hon’ble Court
13 Annexure A11: Copy of CSE’s report on experts contesting the new policy
http://www.downtoearth.org.in/content/experts-contest-new-vaccine-policy-document
14 Annexure A12: Copy of report published in Mail Today showing how policy supports manufacturers
http://indiatoday.intoday.in/story/draft-national-vaccine-policy-favouring-industry/1/158925.html
15 Annexure A13: Copy of Lancet article on UN’s conflict of interest
16 Annexure A14 (Colly): Reports on how vaccine industry benefitted from WHO’s alarmist declarations on swine flu
17 Annexure A15: Letter of Ms. Brinda Karat on HPV vaccine trial
18 Annexure A16: Editorial in The Hindu on HPV vaccine trial
http://www.thehindu.com/opinion/editorial/article2021657.ece
19 Annexure A17: Report on the serious lapses in the HPV vaccine trial
20 Annexure A18 (Colly): Reports on the way vaccines are pushed onto Indian children
21 Annexure A19: Government admits to lapses in HPV vaccine trial
22 Annexure A20: Copy of letter of Dr. Puliyel to the Health Secretary criticizing the new vaccine policy
See below
23 Annexure A21: Article published in EPW on the vaccine policy
http://jacob.puliyel.com/download.php?id=244
24 Annexure A22 (Colly): Studies and reports on how vaccination policies are being led by industry
25 Annexure A23: Published letter showing how the cost of pneumococcal vaccine was underestimated by 10 times
http://jacob.puliyel.com/download.php?id=239
25 Annexure A24: Report on WHO acceding to concerns of doctors on Hepatitis B vaccine
(PRASHANT BHUSHAN)
COUNSEL FOR THE PETITIONERS
301, NEW LAWYERS CHAMBERS
SUPREME COURT OF INDIA
NEW DELHI-110 001
NEW DELHI CODE NO. P195 DATED: ENROLLMENT
Letter to NTAGI
To
Mr. K Chandramouli
The Secretary
Health and Family Welfare
Nirman Bhawan
New Delhi
Dear Mr. K Chandramouli
Thank you for the invitation dated 6 June 2011 to the NTAGI meeting on 13 June 2011.
I would like to raise the following points at the meeting and the agenda may please be modified suitably.
1. Discussion of Minutes of meeting of 26 August 2011
Agenda Item 5- National Vaccine Policy
The original minutes had recorded that:
‘Dr. NK Ganguly, Ex-DG, ICMR would draft a National Vaccine policy; Dr. Jacob Puliyel, will also provide his inputs in facilitating the drafting the policy document. Thereafter the policy document will be circulated to all members for their inputs before the final draft is discussed in the NTAGI meeting.’
The minutes were then altered to delete the name of Jacob Puliyel.
I must request the chair to tell the house at whose behest this alteration was made and who colluded? How can we prevent repetition of this in the future? I had earlier suggested recording of the proceedings.
Regarding the draft policy: What has been done with the inputs from members on this draft?
When will the draft be discussed in the NTAGI?
2. This NTAGI meeting has been called to ‘discuss the proposal for expansion of Pentavalent vaccine to some other States’
Whose proposal is this?
Is it a proposal of the Government of India?
Is it proposed by some other agency?
This needs to be explicitly stated.
I request that we be informed about this at the meeting.
3. Concerns about Pentavalent Vaccine Safety and its Utility
The stated rationale for introducing the vaccine in India were recently called into question at the Planning Commission. I have attached that document but more ominous is the safety record of the vaccine. There have been several deaths immediately following vaccination. As such, if the vaccine is to be introduced a vote must be taken, and I request that my dissent must be recorded stating the following reasons:
There have been many death in neighboring countries immediately following use of Pentavalent vaccine.
Sri Lanka Deaths
The ICMR has given the Delhi High Court a report of the WHO expert group investigating Sri Lanka deaths, saying the vaccine ‘was unlikely to be the cause for the deaths’. However this report states clearly that no other cause was found to explain the deaths which happened soon after vaccination. Using the Brighton Classification of the WHO, this would be classified as ‘Probably related to Vaccine’. The report given to the Delhi High Court says that the Experts of this investigation removed the categories ‘Probably related’ and ‘Possibly related to the vaccine’ from the Brighton Classification and made their own improvised classification. This is how the deaths came to be classified by these ‘experts’ as ‘unlikely to be related to vaccine’
Pakistan Deaths
Professor SK Mittal writing in the BMJ has recorded the following
“According to an expert on the committee investigating the Pakistan deaths, one child died within half an hour of receiving the vaccine and 2 others died within 12 to 14 hours. No alternate cause of death was found for any of the deaths but the experts misleadingly suggest that ‘two cases were diagnosed as Sudden Infant Death Syndrome (SIDS) but we (the experts) were not sure of the third case’.
Sudden Infant Death Syndrome (SIDS) is a diagnosis of exclusion when no cause can be found and to call sudden death following a vaccine as SIDS suggests a lack of understanding of the term or worse, it points to an attempt to obfuscate.
Bhutan Deaths
Professor Mittal also points out:
“The 'expert report' on the 8 deaths in Bhutan is not available in the public domain as far as we can ascertain. A WHO spokesperson is reported to have said the cause of death in Bhutan was not vaccination, but they were due to a three other causes namely ‘sudden death, convulsions and meningitis’”.
(Professor S. K. Mittal 'Sudden Deaths' after Pentavalent vaccination: Is the vaccine really safe? BMJ http://www.bmj.com/content/340/bmj.c3508/reply#bmj_el_239257?sid=0d933918-9cbf-4fc3-a023-d6705097271f)
India Deaths
4 children died in Lucknow in August 2010. Although Measles vaccine was sought to be blamed The Hindu and some other news channels (http://ipsnews.net/news.asp?idnews=52638) noted that some of those who died were only 3 months old (well below the age to receive measles vaccine). The Hindu reported the deaths could have been due to pentavalent vaccine. This has not been denied by the Government. The Health Minister said that experts were investigating the deaths and their report will show which vaccine was used. 10 months later, the vaccine involved has not been revealed and the Government has refused to respond to an RTI about it, saying the matter was ‘subjudice’.
The Hindu report is below
http://hindu.com/2010/08/24/stories/2010082457281300.htm
Initially, it was said that three deaths had occurred due to the anti-measles vaccine and one death due to the BCG shot. Then it was said the children were given BCG vaccine instead of anti-measles, and it was also said that the shots were pentavalent vaccine given during a pilot project under the universal immunization programme. All these questions will be answered once the enquiry was complete, the Minister said, adding there was an internationally prescribed procedure to be followed during vaccination.
With these facts known about sudden deaths following this vaccine, I would consider myself foolhardy and reckless to agree to introduce the vaccine in more states without proper study. Even in the States of Tamil Nadu and Kerala it must be introduced very cautiously, in limited areas where both the side effects and benefits can be monitored. My dissent may please be recorded.
Jacob Puliyel
Letter to Health Secretary about Draft Policy
Sub: National Vaccine Policy and Advance Market Commitments
Dear Sir,
I write to you as a member of the National Technical Advisory Group on Immunization (NTAGI) and put on record some of my concerns in making of a ‘National Vaccine Policy’– a document seemingly drafted a by few persons without much needed consultations or even a modicum of public debate. What is worrying, is the process as it has not been discussed or sanctioned by this expert body of which I am member. The NTAGI had resolved (meeting of 26 August 2010) that the policy was to be drafted by Dr Ganguli with help from Jacob Puliyel and this was stated in the first version of the minutes circulated after the meeting. But it did not happen this way; one wonders at whose behest, the collective decision of the NTAGI was overruled.
I believe that a section of Ministry of Health cannot unilaterally make a policy that is binding on all future governments, to honor advance-marketing-commitment it has entered into, to favor some vaccine manufacturer.
What the policy prescribes
There are serious issues that this policy raises on pages 10, 11 and 16. The policy document states it will be “mandatory for the government to support advance market commitments and honor the commitments”[1].
Advance market commitments (AMC) are made even before the prototype of the vaccine is produced. The commitments are made before the vaccine is tested for its efficacy/effectiveness in the local population. Advance commitments are made with a front end loading (meaning a very high price to start with) and a tail price (a little lower price after some 5 years), all of which are negotiated well before the vaccine is made - leave alone tested!! The first manufacturer past the goal post (who makes a vaccine) gets the contract. It is for many years - usually at least 5 years. Ordinarily the World Bank holds the money for the AMCs for several years in advance.
Page 16 of the policy goes further to suggests the government use ‘innovative finance mechanisms’ (GAVI terminology that means the Government must take loans by the issue of bonds) to pay the World Bank in advance. By including the line making AMC mandatory on all future Governments, the authors of this policy propose to bind the hands of all future governments. Such a decision can only be made if there is widespread consensus for the proposal in Parliament.
There has been recent press coverage of this issue of AMC in the policy.[2]
In the magazine Down to Earth, the author of the policy says , “The government will commit to the manufacturers so that they invest in vaccine production. If governments do not commit, the company which will set up the plant exclusively for the need of the country, may sink because no one else would want that vaccine and the company would be producing it exclusively for the country which demanded it,…”. This statement is self explanatory. In the same article he also says that, “..One contract will last for a year for one programme. Once the programme is over, the government will revise the programme and select new companies. If the government wants to discontinue a particular vaccine after a year, it can easily do that…”
The above statements contradict each other, while in the first he is worried about the vaccine companies, in the second he withdraws from this. This tacit admission of the fact that long term advance market commitment is not defensible and it may not be in the national interest but merely in the interest of private vaccine manufacturers, is reassuring.
According to the article in Down to Earth, this policy was approved by UN agencies but failed to consult Indian experts or take the Indian public into confidence. A recent publication authored by 8 international experts on behalf of 140 organisations of the world has drawn attention to the fact that UN is playing into the hands of all kinds of industry with huge conflicts of interests.[3]
Current global mechanisms established around vaccination are under scanner because of conflicts of interests. “The extent and range of relationships between tax-exempt foundations and for-profit corporations suggest that transparency or grant-making recusal of employees alone may not be preventing potential conflicts of interests between global health programs and their financing”. This is because of the Gates Foundation-supported project-- Advance Market Commitment (AMC)-- a market expansion strategy for increasing profits for vaccine manufacturers masquerading as an innovative method for developing vaccines for neglected disease to save the lives of millions of poor children…”[4]
The Missing Point
The vaccine policy ideally would state how the government proposes to universalize the benefits of immunization to the large sections who don’t receive the basic vaccinations. It would also describe how new vaccines are to be selected for introduction in the programme for universal immunization. Ideally it would lay down the process of selection of members to the NTAGI and how the procedures of this committee are to be recorded and made open to the public. Methods of estimating disease burden, vaccine efficacy, and assessment of costs, benefits and adverse effects of newer vaccines; and the process of how new vaccines are to be introduced, should have found a place in the policy. Unfortunately the draft is non committal on almost all of these issues.
Notwithstanding all this I would have welcomed a draft policy that was in the interest of public health. Unfortunately the policy as published ignores the interest of millions of children who are left out from the routine vaccination.
I would like to place my concerns on record and include as agenda items in the next NTAGI meting.
I look forward to your kind response to my request.
With best regards,
Sincerely yours
Jacob Puliyel MD MRCP M Phil
Pediatrician
Member of the National Technical Advisory Group on
Immunization (NTAGI) and of the Working Group on Food and Drug
Regulation in the 12th Five Year Plan.
puliyel@gmail.com
________________________________________
[1] http://www.slideshare.net/prabirkc/national-vaccine-policy-2011
[2] http://www.downtoearth.org.in/content/experts-contest-new-vaccine-policy-document
[3] http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61463-3/fulltext
[4] http://www.ahrp.org/cms/content/view/799/55/