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PIL on Clinical trial of anti-diarrhea vaccine Rotavac: SC issues Notice to Centre, DBT and CMC Vellore [Read Petition]

July 5, 2016

Supreme Court today issued notice to the Centre, Department of Bio-Technology (DBT) and Christian Medical College, Vellore in a PIL filed by S. Srinivasan seeking complete centre-wise results of the clinical trial of anti-diarrhea vaccine Rotavac. Advocate Prashant Bhushan appeared for the Petitioner.

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 three centres.

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.

The petitioner submitted 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 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, Delhi 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 Petition stated that the High Court had  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 High Court of Delhi. On 05.02.2016 the 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 Supreme 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”.

The Petitioner submitted that he 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 had already expressed its views in the matter, the petitioner has sought the intervention of Supreme Court to set aside the Order date d 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 has also sought 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. Read the petition here.

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