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

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...

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

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