<p>Almost two years after the Central government was compelled to stop a highly controversial HPV vaccination programme among tribal teenage girls in Andhra Pradesh and Gujarat, a new British study suggests there was no medical justification to roll out the campaign in the first place.<br /><br /></p>.<p>Intended to protect young girls against cervical cancer caused by Human Papilloma Virus, the 2009 HPV vaccine trial was launched by state governments with support from the Indian Council of Medical Research and a US-based non governmental organisation, PATH.But in the wake of several allegations of serious violation of ethical norms and deaths following vaccination, the Centre cancelled the trial midway and instituted an inquiry, which has identified “several deficiencies in the planning and implementation of the project” in its final report.<br /><br />A review carried out by UK-based public health specialists suggests that existing data on the disease causing virus and cervical cancer incidence do not support PATH’s claim of India having a large burden of cervical cancer that requires rolling out of the vaccine programme.Not only the national trend in cervical cancer in India fell from 42.3 to 22.3 per 100,000 between 1982-83 and 2004-05, both states had low incidence and mortality rates due to cervical cancer, says the study published in a recent issue of Journal of Royal Society of Medicine. The mortality is 7.7 per 100,000, which is far lower than mortality due to diabetes, heart diseases and TB.<br /><br />The researchers from the University of Edinburgh and Queen Mary University, London, scoured through every published research on prevalence and incidence in HPV to find out if the PATH trial was justified. It also traced five studies quoted by PATH in its strategy document advocating vaccination.Of the five studies cited by PATH, one could not be traced and the remaining four did not had any indication of the magnitude of the problem in the two districts — Khammam in Andhra Pradesh and Vadodra in Gujarat — where the trials were carried out under controversial circumstances.The vaccines came from two pharma majors. It was MSD or Merck Sharp Dhome which supplied the vaccine (Gardasil) for Andhra, whereas Glaxo Smith Klime was the supplier of vaccine (Ceravix) for Gujarat.The World Health Organisation accepts that baseline epidemiology of a disease should be known and be of sufficient importance to start a vaccine trial. Also trials have to be accompanied by a capable surveillance system to assess the vaccine’s impact following the introduction.</p>
<p>Almost two years after the Central government was compelled to stop a highly controversial HPV vaccination programme among tribal teenage girls in Andhra Pradesh and Gujarat, a new British study suggests there was no medical justification to roll out the campaign in the first place.<br /><br /></p>.<p>Intended to protect young girls against cervical cancer caused by Human Papilloma Virus, the 2009 HPV vaccine trial was launched by state governments with support from the Indian Council of Medical Research and a US-based non governmental organisation, PATH.But in the wake of several allegations of serious violation of ethical norms and deaths following vaccination, the Centre cancelled the trial midway and instituted an inquiry, which has identified “several deficiencies in the planning and implementation of the project” in its final report.<br /><br />A review carried out by UK-based public health specialists suggests that existing data on the disease causing virus and cervical cancer incidence do not support PATH’s claim of India having a large burden of cervical cancer that requires rolling out of the vaccine programme.Not only the national trend in cervical cancer in India fell from 42.3 to 22.3 per 100,000 between 1982-83 and 2004-05, both states had low incidence and mortality rates due to cervical cancer, says the study published in a recent issue of Journal of Royal Society of Medicine. The mortality is 7.7 per 100,000, which is far lower than mortality due to diabetes, heart diseases and TB.<br /><br />The researchers from the University of Edinburgh and Queen Mary University, London, scoured through every published research on prevalence and incidence in HPV to find out if the PATH trial was justified. It also traced five studies quoted by PATH in its strategy document advocating vaccination.Of the five studies cited by PATH, one could not be traced and the remaining four did not had any indication of the magnitude of the problem in the two districts — Khammam in Andhra Pradesh and Vadodra in Gujarat — where the trials were carried out under controversial circumstances.The vaccines came from two pharma majors. It was MSD or Merck Sharp Dhome which supplied the vaccine (Gardasil) for Andhra, whereas Glaxo Smith Klime was the supplier of vaccine (Ceravix) for Gujarat.The World Health Organisation accepts that baseline epidemiology of a disease should be known and be of sufficient importance to start a vaccine trial. Also trials have to be accompanied by a capable surveillance system to assess the vaccine’s impact following the introduction.</p>
