About 14,000 girls, aged between 10 and 14 years in the Khammam district of Andhra Pradesh were vaccinated with the human papilloma virus (HPV) vaccine as part of a study on the efficacy of the vaccine against cervical cancer last year. These girls were mostly tribal children whose parents were agricultural labourers. The public outcry following the death of six of the girls led to the government suspending the study. It was later found that there were several violations of existing protocols. The parents of the girls, who were staying in hostels, were never informed. Instead, consent was taken from the wardens.
The government denies that the HPV vaccination was a clinical trial. Whether it was a trial or a study, there is no denying that the dramatic explosion in the number of clinical trials being conducted in India - from just about 100 in 2005 to over 1, 000 in 2010 - is leading to concerns about the safety of those recruited for the various trials.
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