December 9, 2010
The three-member committee inquiring into the incident in Andhra Pradesh in which four girls died after having been administered the Human Papilloma Virus (HPV) vaccine used to prevent cervical cancer has found that the deaths were “most probably unrelated to the vaccine”.
“There was no major ethical violation in the conduct of the study in the way it has been done”, says the interim report of the committee probing the “alleged irregularities in the conduct of studies using HPV vaccine by PATH in India”. The report has been submitted to the Union Health Ministry.
The NGO PATH had been carrying out trials of the HPV vaccine in Andhra Pradesh and Gujarat in collaboration with the state governments and Indian Council of Medical Research (ICMR) since 2007. The study was suspended following reports of the girls’ deaths. The trials in Andhra were using MSD’s Gardasil; those in Gujarat, GSK’s Cervarix.
The inquiry committee was formed after CPM leader Brinda Karat alleged that guidelines were violated and girls from vulnerable sections were exploited in the garb of the trials.
The interim report has described PATH’s study as well designed and adequately documented. It had “necessary approvals” from all required agencies including “national- and state-level advisory committees, institutional ethics committees of the sates, DCGI and the Health Ministry’s screening committee”. This is in contrast to the report of the Secretary, Health Research, who had submitted to a Parliamentary Standing Committee that “DCGI guidelines were not adhered to”.
The committee has, however, found deficiencies in the planning and implementation of the project, which led to the crisis that ultimately ended in the suspension of the study. Details will be documented in the final report, likely to be submitted later this month.