Supreme Court Rotavirus vaccine data disclosure petition

http://www.livelaw.in/pil-clinical-trial-anti-diarrhea-vaccine-rotavac-sc-issues-notice-centre-dbt-cmc http://www.livelaw.in/pil-clinical-trial-anti-diarrhea-vaccine-rotavac-sc-issues-notice-centre-dbt-cmc-vellore/

S Srinivasan Prashant Bhushan

IN THE SUPREME COURT OF INDIA

(CIVIL ORIGINAL JURISDICTION)

WRIT PETITION (CIVIL) NO.________ OF 2016

(PUBLIC INTEREST LITIGATION)

IN THE MATTER OF:

S. SRINIVASAN ... PETITIONER

VERSUS

UNION OF INDIA & OTHERS ... RESPONDENTS

PAPERBOOK

(KINDLY SEE INSIDE FOR INDEX)

ADVOCATE FOR THE PETITIONER: PRASHANT BHUSHAN

SYNOPSIS AND LIST OF DATES

The petitioner herein is filing the instant writ petition in public interest

under Article 32 of the Constitution of India for the enforcement of

rights under Article 14 and 21 of the citizens seeking a writ directing

the respondents to make public the segregated data (center-wise

results) of the Rotavac clinical trial (phase III) that was conducted on

6799 infants at three centres namely Delhi, Pune and Vellore between

2011-2013 to gauge the safety and efficacy of the said vaccine. The

petitioner at this stage is not casting aspersions on the efficacy of the

said vaccine but is only asking for complete segregated data to be

provided. The segregated data is crucial to know if the vaccine is safe

in all areas or if some groups are more susceptible to adverse events

from the vaccine. The very raison d’etre of such multicenter trials is to

compare results among centers. This data should have been

examined by the National Technical Advisory Group on Immunization

(NTAGI) in public interest but such is the secrecy surrounding it, it has

not been provided even to this apex body. The instant petition is

asking for the data to be provided to the petitioner or made available in

the public domain.

Facts of the Case

On 26th March 2016, the Ministry of Health officially launched

Rotavirus vaccine to combat deaths in infants caused due to diarrhea.

Before the launch of the vaccine, a clinical trial (phase III) was

conducted between 2011 and 2013 at three centres namely Delhi,

Pune and Vellore to gauge the efficacy and safety of the said vaccine.

Under this clinical trial, 6799 infants were administered the said

vaccine to ensure its safety in terms of the number of intussusceptions

in the 2-year trial period. Intussusceptions are intestinal obstructions

that may need an urgent surgery to prevent death among infants, and

is diagnosed by ultra sound examination. The trial was done as per

protocol to test the risk of this potentially fatal side-effect of the

vaccine over an observation period of 2 years. Multiple trial sites were

included to ensure different geographic areas to include a wider range

of population groups with allows comparison of results among centers

and increases the generizability of the study..

The aggregated results of the study published in UK Journal “Vaccine”

issue dated August, 2014 raised certain questions about the efficacy

of the vaccine and the risks associated with it. Through these

aggregated results, an expert member of the National Technical

Advisory Group on Immunization (NTAGI), which is the apex advisory

body of the Government of India on immunization, Dr. Jacob Puliyel

deduced that the number of cases of intussusceptions in the infants

who were administered ‘rotavirus’ vaccine in Vellore centre were the

highest and there was a huge difference in the number of cases of

intussusceptions between result in Delhi and Vellore. As a member of

NTAGI, Dr. Puliyel considered it his duty to study the segregated

results of the clinical trial data from all the three centres to ascertain if

a certain population was more susceptible to the side effects of the

said vaccine. However, the respondents did not publish the centre-
wise results of the said trial.

In his capacity as the member of NTAGI, Dr. Puliyel repeatedly made

requests for the said results but the results were not provided to him.

Dr. Puliyel made several representations to the Director, CMC Vellore

requesting for the data for Vellore limb of the study. His request was

not acceded to. He also wrote to the NTAGI by writing emails

addressed to Dr. Vijaya Raghavan, Chairperson of Standing Technical

Sub-Committee (STSC) of NTAGI (and copying to all members of

NTAGI) requesting for the disaggregated data from Vellore in the

format provided by him as a member of NTAGI. However, the results

from Vellore were not provided.

It is submitted that not providing complete results of clinical trials

involving human beings is in violation of ethics of medical research

and global norms governing clinical trials. Raising this issue, journal

Vaccine published a detailed letter dated 06.10.2014 asking for

segregated centre-wise results of the clinical trial to be published. As a

result of the letter many newspapers through their science

correspondents tried to get the information directly from the Principal

Investigator but the respondents did not provide the said data from the

In the mean time, an NGO also filed an RTI application seeking

information on a.) the number of cases of intussusceptions diagnosed

as ‘Possible intussusception’ (meaning exhibiting clinical evidence of

intussusception diagnosed by the trial doctor as described in the study

protocol) and numbers with ultrasound evidence of intussusception in

the 1000 infants given the rotavirus vaccine in Vellore limb of study

over the period of 2 years and, b.) what is the corresponding figure for

the 500 who were placebo recipients. But no reply was given to the

RTI application by the respondents.

In response to Dr. Puliyel letter to the Prime Minister dated

16.06.2015, the Prime Minister’s Office made a request to the Subject

Expert’s Committee to look at the data from Vellore. As per the

minutes of the meetings of SEC dated 29.07.2015, the same has not

yet been complied with. This shows that not only the NTAGI but even

the Subjects Expert Committee has not examined the Vellore data

even after a reference for the same by the PMO.

Why is it important to disclose centre-wise data

The petitioner submits that there is a need for disclosure of the

segregated data of Vellore Centre in order to ascertain whether a

certain section of the population is more susceptible to adverse

effects. This was the very objective of the multi-centre clinical trial. So

far the respondents have shown complete secrecy in the matter and

have not disclosed segregated ( meaning dis-aggregated) data from

all the centres and have only released aggregated data i.e. the results

of all three centres clubbed together. Concealing of this vital data does

severe injustice to the thousands of infants who participated in this

study, the researchers who painstakingly conducted the trials and the

medical/scientific community who depend on this data for their work. It

is even more crucial to study the segregated data because the

respondents have now launched the vaccine in 4 states in the country

where lakhs of infants might be administered the vaccine. It is

submitted that informed consent requires the disclosure of safety data,

and it would be unethical to proceed with immunisation without

informing the public of any risks observed with previous use of the

vaccine, and not informing them what adverse effects to look out for.

Earlier Petition seeking the same relief

Aggrieved by the attitude and callousness on the part of the

respondents, Dr. Jacob Puliyel filed Writ Petition No.6913 of 2015

before the Hon’ble High Court of Delhi praying for the ethical

disclosure of the disaggregated data of all the centres where the study

was conducted. In the said matter, Vide order dated 14.10.2015, the

Hon’ble High Court had dismissed the said writ petition on the ground

that segregated trial result of all the three centres was available with

the National Technical Advisory Group on Immunization (NTAGI) of

which the petitioner is a member and that it was on the basis of this

data that the NTAGI approved the said vaccine.

The Hon’ble High Court failed to appreciate the fact that the

segregated results of the clinical trial were not made available to

members of the NTAGI in spite of written requests for the same by Dr.

Puliyel. Aggrieved by the order, Dr. Puliyel was constrained to filed an

SLP (Civil) No.2532 of 2016 against the Order dated 14.10.2015 of the

Hon’ble High Court of Delhi. On 05.02.2016 the Hon’ble Court while

keeping all questions open expressed its inability to entertain the said

SLP on the ground that the petitioner therein, who was a member of

the NTAGI, cannot maintain a public interest petition. The Hon’ble

Court in the said order dated 05.02.2016 in SLP (C) No.2532 of 2016

stated as under:

Learned counsel for the petitioner seeks leave to withdraw this

petition. This petitioner cannot maintain a petition in public

interest since he was a member of the National Technical

Advisory Group on Immunization which recommended the

introduction of the vaccine in question. Leave to withdraw is

granted. The special leave petition is dismissed as withdrawn.

All questions are left open.

Therefore, the petitioner herein has filed the instant writ petition

espousing the same cause of ethical and complete disclosure of

clinical trial conducted on human beings. Since the High Court has

already expressed its views in the matter, the petitioner herein seeks

the intervention of this Hon’ble Court to set aside the Order dated

14.10.2015 of the High Court of Delhi and to direct the respondents to

disclose and publish the segregated results of the clinical trial of

Rotavac vaccine conducted on 6799 infants in the period between

2011-2013 at Delhi, Pune and Vellore. The petitioner also seeks an

interim direction that the segregated results from all the three centres

be placed before the NTAGI, which is the expert body on

immunization policy, for examination and scrutiny.

List of Dates

Dates Events

11.03.2011 Department of Biotechnology, Ministry of Science and

Technology, Government of India conducted a Phase III

randomized, double-blind, placebo-controlled trial,

hereinafter “the clinical trial”, of 116E rotavirus vaccine.

The study was conducted at three centres namely Pune,

Delhi and Vellore.

October 2013 Revised version of Declaration of Helsinki is adopted

which states that “Every research study involving human

subjects must be registered in a publicly accessible

database before recruitment of the first subject.” and that

“Researchers have a duty to make publicly available the

results of their research...." Negative and inconclusive as

well as positive results must be published or otherwise

made publicly available”.

05.11.2013 The above mentioned clinical trial was completed.

March 2014 Lancet published a paper on the said study. However the

paper did not provide segregated data for different

centres of the clinical trial.

August 2014 Questions about the efficacy and the risk associated with

the rotavirus vaccine were raised in a paper authored by

John and colleagues published in journal Vaccine titled

‘Active surveillance for intussusception in a phase III

efficacy trial of an oral mono-valent rotavirus vaccine in

India’

06.10.2014 The Vaccine published a detailed letter dated 06.10.2014

asking for this data to be published but the Principal

Investigator has not responded to this scientific appeal.

March 2015 The Prime Minister launched Rotavirus

vaccine Rotavac, developed by Hyderabad-based Bharat

Biotech. The said vaccine has been ostensibly approved

by the government after a clinical trial conducted to

gauge its efficacy and safety

14.04.2015 World Health Organization (WHO) released a strong

statement advocating for public disclosure of all clinical

trial results. According to it, when data is not released it

means that doctors, patients and medical regulators

cannot make informed decisions about which treatments

are best. Non-disclosure of complete clinical trial results

means that hundreds of thousands of patients have

volunteered to take part in clinical trials where results

have been kept hidden or are only selectively disclosed.

12.05.2015 One of the largest online campaigning communities

called Avaaz.org starts a campaign requesting the

Director, CMC Vellore to release the clinical trial data. As

of now campaign has 442 signatories from the world over

but no response has been received so far from CMC

Vellore. The online petition can be accessed at:

https://secure.avaaz.org/en/petition/To_The_Director_Ch

ristian_Medical_College_Vellore_632004_Release_India

n_Rotavirus_Vaccine_Trial_Data/.

21.05.2015 Dr. Puliyel made representations to Mr. Sunil Chandy,

Director of CMC Vellore requesting the for the data for

Vellore limb of the study. His request was not acceded

to.

26.05.2015 An NGO filed an RTI application seeking information on

the number of cases of intussusceptions in Vellore limb

of study. No response has been received for the same.

28.05.2015 Dr. Puliyel, as a member of NTAGI wrote a letter to Dr.

Vijaya Raghavan, Chairperson of Standing Technical

Sub-Committee (STSC), NTAGI and copied to all

members of NTAGI requesting for the disaggregated

data from Vellore in the format provided by him as a

member of NTAGI on or before the meeting of the STSC

that was scheduled for June 10. However, his request

was not acceded to.

30.05.2015 The Hindu published an article stating that the

Government now plans to study the vaccine in 100,000

infants, without providing evidence of safety in the 1000

children already studied in Vellore.

16.06.2015 Dr. Puliyel wrote letter to the Prime Minister apprising

him of the situation and requesting him to enquire into

the matter.

22.06.2015 The Prime Minister's Office (PMO) made a reference

(PMO ID No. 4219998//2015 dated 22.06.2015)

forwarding the concerns over the SAE of intussusception

in children in recently launched indigenous Rotavirus

vaccine (Rotavac).

07.2015 Writ Petition (Civil) No. 6913 of 2015 was filed at the

Hon’ble High Court of Delhi praying for the segregated

trial research from all the three centres.

29.07.2015 Minutes of the Meeting of Subject Expert Committee

(SEC) – Vaccine show that even after the PMO

reference dated 22.06.2015, the SEC did not review the

data with respect to Vellore limb of the study and gave its

opinion based on the already published data in the

journal Vaccine.

14.10.2015 The Hon’ble High Court of Delhi dismissed Dr. Puliyel’s

petition on the ground that the entire data was in fact

available with NTAGI despite the fact that the petitioner

therein was himself a member of NTAGI and was never

provided the disaggregated data.

12.01.2016 Dr. Puliyel thereafter preferred SLP (C) 2532 of 2016

against the impugned order dated 14.10.2015 of the

division bench of the Hon’ble High Court of Delhi at New

Delhi.

05.02.2016 The Hon’ble Court in SLP (C) 2532 of 2016 stated its

inability to entertain the said SLP on the ground that the

petitioner therein, who was a member of the NTAGI,

cannot maintain a public interest petition. The Hon’ble

Court in its order dated 05.02.2016 in SLP (C) No. 2532

of 2016 stated as under: Learned counsel for the

petitioner seeks leave to withdraw this petition. This

petitioner cannot maintain a petition in public interest

since he was a member of the National Technical

Advisory Group on Immunization which recommended

the introduction of the vaccine in question. Leave to

withdraw is granted. The special leave petition is

dismissed as withdrawn. All questions are left open.

26.03.2016 Rotavac vaccine is launched in four states in the country

with plans to include it in the Universal Immunization

Policy of the government of India

23.04.2016 The petitioner herein Mr. S. Srinivasan files the instant

Writ Petition

IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION (CIVIL) NO. OF 2015

IN THE MATTER OF:-

S. SRINIVASAN

S/O SATAGOPAN SOURIRAJAN

R/O 1 TEJAS APTS, 53 HARIBHAKTI COLONY, OLD PADRA RD.,

VADODARA 390007

MANAGING TRUSTEE,

LOCOST (LOW COST STANDARD THERAPEUTICS),

VADODARA, GUJARAT

EMAIL: CHINUSRINIVASAN.X@GMAIL.COM

PH NO.: 8860867102/ 9998771064 .... PETITIONER

VERSUS

1. THE UNION OF INDIA

THROUGH ITS SECRETARY

MINISTRY OF HEALTH & FAMILY WELFARE

NIRMAN BHAWAN, NEW DELHI-110001

2. THE UNION OF INDIA

THROUGH ITS SECRETARY

DEPARTMENT OF BIO-TECHNOLOGY

MINISTRY OF SCIENCE AND TECHNOLOGY

6TH-8TH FLOOR, BLOCK 2

CGO COMPLEX, LODHI ROAD

NEW DELHI - 110 003

3. CHRISTIAN MEDICAL COLLEGE

THROUGH ITS DIRECTOR

CMC VELLORE, 632004

TAMIL NADU ...RESPONDENTS

The Chief Justice of the Hon’ble Supreme Court of India and his

companion Justices of the Supreme Court of India:

MOST RESPECTFULLY SHOWETH:

1. The petitioner herein is filing the instant writ petition in public

interest under Article 32 of the Constitution of India for the

enforcement of rights under Article 14 and 21 of the citizens

seeking a writ directing the respondents to make public the

segregated data (result) of the Rotavac clinical trial (phase III)

involving 6799 infants, that was conducted at three centres namely

Delhi, Pune and Vellore to gauge the safety and efficacy of the said

2. The Petitioner is Mr. S. Srinivasan. He is the Managing Trustee of

(Low Cost Standard Therapeutics), Vadodara, Gujarat. The

petitioner is an expert and has been active for over 35 years in the

field of health care, low cost medicine manufacture, transfer of

pharmaceutical technology to LDCs, issues of disadvantaged

children and human rights, and relief in disaster situations. He is an

active member of the Medico Friend Circle and AIDAN (All-India

Drug Action Network) among others. Mr. S. Srinivasan is a

graduate and postgraduate of IIT Kharagpur and IIM Bangalore. His

recent books include A Lay Person’s Guide to Medicine (2000/2006

and 2012 in Hindi), Impoverishing the Poor: Pharmaceuticals and

Drug Pricing in India as well as several articles pharma policy, drug

pricing and related issues in the Economic and Political Weekly as

well as contributed chapters in books. The petitioner, through

LOCOST, has previously filed petitions in the Supreme Court on

inter alia irrational medicines, drug pricing policy, vaccine PSUs

closure and HPV vaccine related deaths. His annual income is of

Rs. 5,00,000. His PAN Card No. is AFVPS3170B.

3. The petitioner has filed the instant writ petition in public interest

under Article 32 of the Constitution of India for the enforcement of

rights under Article 14 and 21 of the citizens seeking a writ directing

the respondents to make public the segregated results of the

Rotavac clinical trial (phase III) conducted between 2011 and 2013

at Delhi, Pune and Vellore. The clinical trial involved administering

the rotavac vaccine to 6799 infants with an objective of ascertaining

and ensuring the safety and efficacy of the said vaccine at all the

three centres. The petitioner herein is also seeking the intervention

of this Hon’ble Court to is also seeking a relief in the form of a

direction from this Hon’ble Court to direct the respondents to place

before the NTAGI the entire clinical trial results in segregated

manner so that the NTAGI may examine and scrutinize the results

of the said vaccine.

4. NTAGI is the country’s apex advisory committee that provides

guidance to the national policy makers on immunization. Members

of NTAGI include officials from MoHFW; representatives from

immunization action partners such as WHO, UNICEF, the Indian

Academy of Pediatrics and the Indian Medical Association ; and

leading independent experts from diverse fields such as clinical

medicine, public health, immunology, vaccinology, immunization

program etc.

Facts of the Case

5. On 26th March 2016, the Ministry of Health officially launched

Rotavirus vaccine to combat deaths in infants caused due to

diarrhea. Before the launch of the vaccine, a clinical trial (phase III)

was conducted between 2011 and 2013 at three centres namely

Delhi, Pune and Vellore to gauge the efficacy and safety of the said

vaccine. Under this clinical trial, 6799 infants were administered the

said vaccine to ensure its safety in terms of the number of

intussusceptions in the 2-year trial period. Intussusceptions are

intestinal obstructions that may need an urgent surgery to prevent

death among infants, and is diagnosed by ultra sound examination.

The trial was to test the risk of this potentially fatal side-effect of the

6. The aggregated results of the study published in UK Journal

‘Vaccine’ issue dated August, 2014 raised certain questions about

the efficacy of the vaccine and the risks associated with it. A paper

authored by John and colleagues published in journal Vaccine titled

‘Active surveillance for intussusception in a phase III efficacy trial of

an oral mono-valent rotavirus vaccine in India’ showed that the

intusseption rate in Vellore was almost 20 times the rate in Delhi. A

copy of the said paper published in journal Vaccine by John &

Colleagues is annexed as Annexure P1 (Pages_____to ____).

7. Through these aggregated results, Dr. Jacob Puliyel of the National

Technical Advisory Group on Immunization (NTAGI), which is the

apex advisory body of the Government of India on immunization,

came to know that the number of cases of intussusceptions in the

infants who were administered rotavac vaccine in Vellore centre

were the highest.

8. As a member of NTAGI, Dr. Puliyel considered it his duty to study

the segregated results of the clinical trial data from all the three

centres to ascertain if a certain population was more susceptible to

the side effects of the said vaccine. The respondents while

celebrating the launch of the vaccine, had not disclosed complete

segregated data (centre-wise results) from these three centres

where this clinical trial was conducted. In his capacity as the

member of NTAGI, he repeatedly made requests for the said

results but the results were not provided to him. Not providing

complete results of clinical trials involving human beings is in

violation of ethics of medical research and global norms governing

clinical trials.

9. Raising this issue, journal Vaccine published a detailed letter dated

06.10.2014 asking for segregated or dis-aggregated results of the

clinical trial to be published. As a result of the letter many

newspapers through their science correspondents tried to get the

information directly from the Principal Investigator but the

respondents did not provide the said data from the three centres. A

copy of the letter dated 06.10.2014 published in journal Vaccine is

annexed as Annexure P2 (Pages_______to_______).

10. Dr. Puliyel made several representations to the Director, CMC

Vellore requesting for the data for Vellore limb of the study. His

request was not acceded to. A copy of his email correspondence

between 21.05.2015 and 28.05.2015 with Mr. Sunil Chandy,

Director, CMC Vellore is annexed as Annexure P3

(Pages______to_____).

11. He also wrote to the NTAGI by writing emails addressed to Dr.

Vijaya Raghavan, Chairperson of Standing Technical Sub-
Commitee (STSC) of NTAGI (and copying to all members of

NTAGI) requesting for the disaggregated data from Vellore in the

format provided by him as a member of NTAGI. However, the

results from Vellore were not provided. A copy of the email dated

28.05.2015 written by the petitioner to the Chairperson STSC,

NTAGI and copied to all members of NTAGI is annexed herewith

as Annexure P4 (Page______ to _____).

12. In the mean time, an NGO also filed an RTI application seeking

information on a.) the number of cases of intussusceptions in the

1000 infants given the rotavirus vaccine in Vellore limb of study

over the period of 2 years and, b.) what is the corresponding figure

for the 500 who were placebo recipients. But no reply was given to

the RTI application by the respondents. A copy of the RTI

application dated 26.05.2015 is annexed herewith as Annexure P5

(Pages______to ______).

13. Dr. Puliyel wrote a letter addressed to the Prime Minister apprising

him of the situation and requesting him to enquire into the matter. A copy

of the letter dated 16.06.2015 written to the Prime Minister about

theneed for disclosure of the data is annexed herewith as Annexure P6

(Pages______ to _____).

14. In response to the letter to the Prime Minister dated 16.06.2015,

the Prime Minister’s Office made a request to the Subject Expert’s

Committee (SEC) to look at the data from Vellore. As per the

minutes of the meetings of SEC dated 29.07.2015, the same has

not yet been complied with. This shows that not only the NTAGI but

even the Subjects Expert Committee has not examined the Vellore

data even after a reference for the same by the PMO. Minutes of

the Meeting of Subject Expert Committee (SEC) – Vaccine show

that even after the PMO reference dated 22.06.2015, the SEC did

not review the data with respect to Vellore limb of the study and

gave its opinion based on the already published data in the journal

Vaccine. A copy of the minutes of the meeting held on 29.07.2015

of Subjects Expert Committee is annexed herewith as Annexure

P7 (Pages_______to ______).

Why is it important to disclose centre-wise data

15. The petitioner submits that there is a need for disclosure of the

segregated data of Vellore Centre in order to ascertain whether a

certain section of the population is more susceptible to adverse

effects. This was the very objective of the clinical trial. So far the

respondents have shown complete secrecy in the matter and have

not disclosed segregated ( meaning dis-aggregated) data from all

the centres and have only released aggregated data i.e. the results

of all three centres clubbed together.

16. It is submitted that the revised version of Declaration of Helsinki is

adopted which states that “Every research study involving human

subjects must be registered in a publicly accessible database before

recruitment of the first subject.” and that “Researchers have a duty to

make publicly available the results of their research...." Negative and

inconclusive as well as positive results must be published or otherwise

made publicly available”. A copy of the relevant section of the revised

Declaration of Helsinki is annexed herewith as Annexure P8

(Pages______to _____).

17. World Health Organization (WHO) released a strong statement

advocating for public disclosure of all clinical trial results. According to it,

when data is not released it means that doctors, patients and medical

regulators cannot make informed decisions about which treatments are

best. Non-disclosure of complete clinical trial results means that

hundreds of thousands of patients have volunteered to take part in

clinical trials where results have been kept hidden or are only selectively

disclosed. A copy of the ‘WHO Statement on Public Disclosure of

Clinical Trial Results’ released on 14.04.2015 is annexed as Annexure

P9 (Pages_____ to _____).

18. One of the largest online campaigning communities called Avaaz.org

starts a campaign requesting the Director, CMC Vellore to release the

clinical trial data. As of now campaign has 442 signatories from the world

over but no response has been received so far from CMC Vellore. The

online petition can be accessed at:

https://secure.avaaz.org/en/petition/To_The_Director_Christian_Medical

_College_Vellore_632004_Release_Indian_Rotavirus_Vaccine_Trial_Da

ta/. A copy of the online petition on avaaz.org is annexed herewith as

Annexure P10 (Pages_____ to _____).

19. Concealing of this vital data does severe injustice to the

thousands of infants who participated in this study, the researchers

who painstakingly conducted the trials and the medical/scientific

community who depend on this data for their work. It is even more

crucial to study the segregated data because the respondents have

now launched the vaccine in 4 states in the country where lakhs of

infants might be administereed the vaccine.

Earlier Petition by Dr. Jacob Puliyel seeking the same relief

20. Aggrived by the attitude and callousness on the part of the

respondents a member of the National Technical Advisory Group

on Immunization (NTAGI) Dr. Jacob Puliyel had earlier filed Writ

Petition No.6913 of 2015 before the Hon’ble High Court of Delhi

praying for the ethical disclosure of the disaggregated data of all

the centres where the study was conducted. A copy of the writ

petition (civil) No. 6913 of 2015 is annexed herewith as Annexure

P11 (Pages______ to _____).

21. Vide order dated 14.10.2015, the Hon’ble High Court dismissed

the said writ petition filed by Dr. Puliyel on the ground that

segregated trial result of all the three centres was available with the

National Technical Advisory Group on Immunization (NTAGI) of

which the petitioner therein was a member and that it was on the

basis of this data that the NTAGI had approved the said vaccine. A

copy of the order dated 14.10.2015 of the Hon’ble High Court in

Writ Petition (Civil) No. 6913 of 2015 is annexed herewith as

Annexure P12 (Pages_____ to _____).

22. The Hon’ble High Court failed to appreciate the fact that the

segregated results of the clinical trial were not made available to

members of the NTAGI in spite of written requests for the same by

Dr. Puliyel. The details of the same are given below. Aggrieved by

the order, Dr. Puliyel was constrained to filed an SLP (C) No. 2532

of 2016 against the Order dated 14.10.2015 of the Hon’ble High

Court of Delhi. On 05.02.2016 the the Hon’ble Court while keeping

all questions open expressed its inability to entertain the said SLP

on the ground that the petitioner therein, who was a member of the

NTAGI, cannot maintain a public interest petition. The Hon’ble

Court in the said order dated 05.02.2016 in SLP (C) No. 2532 of

2016 stated as under:

Learned counsel for the petitioner seeks leave to withdraw

this petition. This petitioner cannot maintain a petition in

public interest since he was a member of the National

Technical Advisory Group on Immunization which

recommended the introduction of the vaccine in question.

Leave to withdraw is granted. The special leave petition is

dismissed as withdrawn. All questions are left open.

A copy of the said Order dated 05.02.2016 of the Hon’ble Supreme

Court in SLP No. 2532 of 2016 is annexed as Annexure P13

(Pages_____ to _____).

23. In March 2016, the said vaccine was launched in four states -

Haryana, Himachal Pradesh, Orissa and Andhra Pradesh with plans to

launch it in other states in the next phase without making public the

segregated results (from Pune, Delhi and Vellore) of the clinical trial of

the said vaccine.

24. The petitioner herein submits that there have been many efforts

on the part of the respondents to keep the segregated results of

clinical trial conducted at the three centres undisclosed. This is

despite the fact that all clinical trials conducted on humans must be

reported entirely because such trials are done on the general public

with public money and therefore the public at large has a right to

know the trial results.

25. The instant Writ Petition is preferred on the ground that the said

study was carried out by government funding and it is the duty of

the respondents to disclose segregated data of clinical trial

involving infants and not keep it under a shroud of mystery and the

same is crucial to enable evaluation of the risks of the vaccine in

different population groups.

26. The petitioner herein has filed the instant writ petition espousing

the cause of ethical and complete disclosure of clinical trial

conducted on human beings. The petitioner at this stage is not

raising aspertions on the efficacy of the said vaccine but is only

asking for complete segregated data to be provided to him and to

members of NTAGI as the same is in public interest.

27. Since the Hon’ble High Court has already expressed its views in

the matter in the earlier petition (WPC 6913 of 2015 ) filed by Dr.

Jacob Puliyel, the petitioner herein seeks the intervention of this

Hon’ble Court to set aside the Order dated 14.10.2015 in WPC

6913 of 2015 of the High Court of Delhi and to direct the

respondents to place the segregated results from all the three

centres before the NTAGI, which is the expert body on

immunization policy, for examination and scrutiny and also to make

the said results public.

GROUNDS

A. Because the respondents have ignored the scientific appeals in

peer reviewed medical journal, RTIs, online appeals of the

petitioner and many others who are to gain by this scientific data

and have failed to provide the said data which can affect millions of

infants in this country.

B. Because if the data from Vellore shows that more children who

were vaccinated had intussusceptions than the controls in Vellore,

it will demonstrate that children in some areas are more susceptible

to this potentially fatal side effect.

C. Because in the said clinical trial there was an excess of 11 cases

of intussusception per 10,000 vaccinated. This is 5 to 10 times

higher than the risk of intussusception with Rotashield vaccine

(which was withdrawn from the market in the USA and nearly 70

times higher than the risk of intussusception with the current,

internationally licensed vaccine - RotaTeq.

D. Because non-disclosure of such important data violates the

basic ethics of clinical research that require results of clinical

research studies to be published and brought to the knowledge of

the medical community, participants to the research and general

E. Because the World Health Organization (WHO) in April 2014 has

released a strong statement advocating for public disclosure of all

clinical trial results.

F. Because when data is not released it means that doctors,

patients and medical regulators cannot make informed decisions

about which treatments are best. Non-disclosure of complete

clinical trial results means that hundreds of thousands of patients

have volunteered to take part in clinical trials where results have

been kept hidden or are only selectively disclosed.

G. Because when researchers embark on a clinical trial, they make

a commitment to conduct the trial and to report the findings in

accordance with basic ethical principles. This includes preserving

the accuracy of the results and making both positive and negative

results publicly available. Selective reporting, regardless of the

reason for it, leads to an incomplete and potentially biased view of

the trial and its results. Selective reporting of clinical trial results can

also lead to wrong or unnecessary allocation of public funds, which

could otherwise have been used in public interest.

H. Because the Declaration of Helsinki, an international document

providing ethical guidance on research states that “Every research

study involving huan subjects must be registered in a publicly

accessible database before recruitment of the first subject.” and

that “Researchers have a duty to make publicly available the results

of their research .... Negative and inconclusive as well as positive

results must be published or otherwise made publicly available”.

I. Because the Government of India has now launched the vaccine

in four states without making the results public and without even

providing it to NTAGI members despite repeated requests.

J. Because vide order dated 14.10.2015 in the earlier Writ Petition

WPC 6913 of 2015, the Hon’ble High Court stated that that the entire

segregated result of all the trial centres was available with NTAGI and

that the NTAGI approved the vaccine having examined the segregated

data. However, the Hon’ble High Court failed to appreciate the fact that

the segregated results of the clinical trial was not made available to the

NTAGI. In fact, as a member of the NTAGI the petitioner in that writ

petition Dr. Puliyel had sought the said data but was not provided the

K. Because Dr. Jacob Puliyel made a number of requests for disclosure of

the data in a peer reviewed scientific journal, to the Chairperson,

Standing Technical Sub Committee of NTAGI, to the director of CMC

Vellore, to the Prime Minister and also filed an RTI seeking the

segregated data from the different centers. However, it was not

provided to him despite the fact that he is himself a member of NTAGI

and ought to have been provided the segregated data.

L. Because the Hon’ble High Court failed in appreciating the fact that the

said clinical trial has been conducted with government funding and the

government owes it to the participants and the people of this country to

know the complete segregated results.

M. Because the segregated data ought to not only be available to the

members of NTAGI but also to the general public under the Right to

Information Act.

N. Because NTAGI is the country’s apex advisory committee that provides

guidance to the national policy makers on immunization. Members of

NTAGI include officials from MoHFW; representatives from

immunization action partners such as WHO, UNICEF, the Indian

Academy of Pediatrics and the Indian Medical Association ; and

leading independent experts from diverse fields such as clinical

medicine, public health, immunology, vaccinology, immunization

program etc. The fact that the respondents cannot even trust the

members of such an exemplary committee with the complete and

segregated results of clinical trial conducted on thousands of infants

calls for an enquiry

O. Because it is mandatory to explain to future recipients the risks that

have already been seen in the Phase III trial before consent is taken

from them for administration of the said vaccine.

P. Because informed consent requires the disclosure of safety data,

and it would be unethical to proceed with immunisation without

informing the public of any risks observed with previous use of the

vaccine, and not informing them what adverse effects to look out

for. The signs and symptoms of this dreaded adverse effect

(namely intussusception) are the same as with dysentery

(meaning the passage of blood and mucus in the stools) and

unless the public are warned before hand, they would suspect

only dysentery and many deaths from intussusception will be

mislabelled as dysentry.

Q. Because when data is not released it means that doctors, patients and

medical regulators cannot make informed decisions about which

treatments are best. Non-disclosure of complete clinical trial results

means that hundreds of thousands of patients have volunteered to take

part in clinical trials where results have been kept hidden or are only

selectively disclosed.

R. Because the request of the Prime Minister’s Office asking the Subject

Experts Committee to look at the Vellore data has not been complied

with in an instance of clear dereliction of responsibility by this expert

PRAYER

It is most respectfully prayed that this Hon’ble Court may be pleased

a. Set aside final order/judgment dated 14.10.2015 of the Hon’ble

High Court of Delhi in WPC 6913 of 2015

b. Issue an appropriate writ directing the respondents to provide

the petitioner the complete segregated results (centre-wise data)

of the clinical trial of rotavac vaccine conducted in all three

centres, including the number of intussusceptions in the 2-year

trial period ar each centre

c. Issue an appropriate writ directing the respondents to place

before the NTAGI the complete segregated results of the said

clinical trial of rotavac vaccine for examination and scrutiny

d. Issue an appropriate writ restraining the respondents from

including rotavac from Universal Immunization Policy of the

government of India till the complete data from the said clinical

trial is not disclosed to the key stakeholders, including the

petitioner.

e. Issue an appropriate writ directing the respondents to frame

guidelines regarding publication of complete and segregated

research results in clinical trials on humans, in accordance with

the WHO statement of April 2015 on the issue.

f. Issue such other writ, direction or order, which this Hon’ble court

may deem fit and proper under the facts and circumstances of

the case.

Drawn By: Neha Rathi

Drawn on: 19/04/2016

FILED BY:

(PRASHANT BHUSHAN)

ADVOCATE FOR THE PETITIONER

FILED ON 23.04.2016

S. NO. PARTICULARS PAGES

1. Listing Performa

2. Brief Synopsis and List of Dates

3. Writ Petition with Affidavit

4. ANNEXURE – P1 A copy of the paper titled

‘Active surveillance for intussusception in a

phase III efficacy trial of an oral mono-valent

rotavirus vaccine in India’ published in journal

Vaccine by John & Colleagues in August 2014

5. ANNEXURE – P2 A copy of the letter dated

06.10.2014 written by the petitioner published

in the journal Vaccine

6. ANNEXURE – P3 A copy of the petitioner’s

7. ANNEXURE - P4 A copy of the email dated

email correspondence between 21.05.2015

and 28.05.2015 with Mr. Sunil Chandy,

Director, CMC Vellore

28.05.2015 written by the petitioner to the

Chairperson STSC, NTAGI and copied to all

members of NTAGI

8. ANNEXURE – P5 A copy of the RTI

application dated26.05.2015

9. ANNEXURE - P6 A copy of the letter dated

16.06.2015 written by the petitioner to the

Prime Minister

10. ANNEXURE - P7 A copy of the minutes of

the meeting held on 29.07.2015 of Subjects

Expert Committee

11. ANNEXURE – P8 A copy of the relevant

section of the revised Declaration of Helsinki

of March 2013

12. ANNEXURE – P9 A copy of the ‘WHO

Statement on Public Disclosure of Clinical

Trial Results’ released on 14.04.2015

13. ANNEXURE – P10 A copy of the online

petition on avaaz.org

14. ANNEXURE - P11 A copy of the writ petition

(civil) No. 6913 of 2015

15. ANNEXURE - P12 A copy of the order dated

14.10.2015 of the Hon’ble High Court in Writ

Petition (Civil) No. 6913 of 2015

16. ANNEXURE - P13 A copy of the said Order

dated 05.02.2016 of the Hon’ble Supreme

Court in SLP No. 2532 of 2016