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→Gates Foundation, PATH, and the death of children from drug testing
PATH carried out a large human papilloma virus (HPV) Phase V vaccine trial. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question were granted marketing approval in India in 2008 while the PATH-sponsored trial began in 2009 as a joint project with the ICMR, using donated vaccines from the manufacturers. Low-income rural, largely tribal, households were recruited. The trial was conducted on girls aged 10 to 14.
PATH carried out a large human papilloma virus (HPV) Phase V vaccine trial. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question were granted marketing approval in India in 2008 while the PATH-sponsored trial began in 2009 as a joint project with the ICMR, using donated vaccines from the manufacturers. Low-income rural, largely tribal, households were recruited. The trial was conducted on girls aged 10 to 14.
Public recognition of problems with this trial started with the reported death of 7 girls. Investigations triggered by these deaths uncovered serious violations of the process of informed consent. Aged 10 to 15, girls in this trial were obviously below the age of consent meaning their participation in the trial required the consent of parents/guardians. The Indian Parliament's Standing Committee on Health began its investigation in April 2010 and concluded that 'safety and rights of children were highly compromised and violated' . The Committee's report found
Public recognition of problems with this trial started with the reported death of 7 girls. Investigations triggered by these deaths uncovered serious violations of the process of informed consent. Aged 10 to 15, girls in this trial were obviously below the age of consent meaning their participation in the trial required the consent of parents/guardians.<ref>http://archive.is/lxTye</ref> The Indian Parliament's Standing Committee on Health began its investigation in April 2010 and concluded that 'safety and rights of children were highly compromised and violated'. The Committee's report found
*The girls' consent was not fully informed.
*The girls' consent was not fully informed.
*Post-vaccination adverse events weren't adequately monitored or reported.
*Post-vaccination adverse events weren't adequately monitored or reported.