New Delhi, Apr 4 (PTI) Data about patients participating in clinical trials cannot be shared, the Central Information Commission has held while dismissing an RTI plea seeking details of stalled Human Papilloma Virus (HPV) vaccine trials in the country.
The HPV vaccine clinical trials are being investigated by a committee of Drug Controller of India as allegations of ethics violations including on informed consent, safety protocols and other such issues were raised from several quarters, the RTI applicants submitted in their plea.
The Government had allowed “Gardasil” (imported by M/s MSD Pharmaceuticals, Gurgaon) and “Cervarix” (imported by M/s GSK Pharmaceuticals, Mumbai), to undergo phase-III clinical trials in India, before granting permission to import and market authorisation.
The trials were started in Khammam, Andhra Pradesh and Vadodara in Gujarat in association with a US-based non-profit organisation PATH. After four deaths of participants in Gujarat and two deaths in Andhra Pradesh were reported, the Government had stopped the trials.
“The cause of deaths was determined as viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite. Based on the concerns on these deaths, states have been advised not to carry out any further vaccinations at present,” Minister of State for Health S Gandhiselvan had informed Parliament.
The applicants wanted to know details of these trials including the data generated from the studies which was denied to them.