Changes

The BMGF funds PATH, a Seattle-based NGO and main recipient of BMGF grant money for global public health initiatives. Since 1998, BMGF has funded PATH to the tune of ~$2 billion. The ICMR is the Indian Government's primary agency tasked with conducting biomedical research.

The BMGF funds PATH, a Seattle-based NGO and main recipient of BMGF grant money for global public health initiatives. Since 1998, BMGF has funded PATH to the tune of ~$2 billion. The ICMR is the Indian Government's primary agency tasked with conducting biomedical research.

What: A Phase V human papilloma virus (HPV) Phase V vaccine trial in Andhra Pradesh & Gujarat, India

'''What: A Phase V human papilloma virus (HPV) Phase V vaccine trial in Andhra Pradesh & Gujarat, India'''

 

PATH carried out a large HPV Phase V vaccine trial in India. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question, Gardasil from Merck and Cervarix from GlaxoSmithKline, 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.

PATH carried out a large HPV Phase V vaccine trial in India. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question, Gardasil from Merck and Cervarix from GlaxoSmithKline, 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.

The purpose of the trial was to generate data to support the inclusion of the HPV vaccine in India's Universal Immunization Programme (UIP).

*The purpose of the trial was to generate data to support the inclusion of the HPV vaccine in India's Universal Immunization Programme (UIP).

Specifically recruiting from low-income rural, largely tribal, households, the trial was conducted on girls aged 10 to 14 using Gardasil in Khammam district of Andhra Pradesh (AP) state (n=13000), and using Cervarix in Vadodara in Gujarat state (n=10000).

*Specifically recruiting from low-income rural, largely tribal, households, the trial was conducted on girls aged 10 to 14 using Gardasil in Khammam district of Andhra Pradesh (AP) state (n=13000), and using Cervarix in Vadodara in Gujarat state (n=10000).

'''The Problems'''

'''The Problems'''

Investigations (1) revealed that

Investigations (1) revealed that

In Andhra Pradesh, 'Signatures of one parent were obtained on 9543 forms, thumb impression of one parent on 1948 forms and signatures of Hostel Warden/Head Master as Guardian in 2763 forms'

*In Andhra Pradesh, 'Signatures of one parent were obtained on 9543 forms, thumb impression of one parent on 1948 forms and signatures of Hostel Warden/Head Master as Guardian in 2763 forms'

The investigators noted, 'The legality of the signing by the Hostel Warden/Head Master in Andhra Pradesh needs to be examined by an appropriate authority'.

*The investigators noted, 'The legality of the signing by the Hostel Warden/Head Master in Andhra Pradesh needs to be examined by an appropriate authority'.

In Gujarat, 'In Gujarat one parent has signed on 6217 forms, has provided thumb impression on 3944 forms and Legal guardian has signed or put thumb impression on 545 forms'.

*In Gujarat, 'In Gujarat one parent has signed on 6217 forms, has provided thumb impression on 3944 forms and Legal guardian has signed or put thumb impression on 545 forms'.

As a newspaper report summarized, signature of ~2800 consent forms had instead been signed by school teachers, principals or hostel wardens, even in cases where the girls had parents (2).

*As a newspaper report summarized, signature of ~2800 consent forms had instead been signed by school teachers, principals or hostel wardens, even in cases where the girls had parents (2).

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' (3).

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' (3).

The Committee's report (3) found

The Committee's report (3) 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.

PATH and ICMR hadn't sought mandatory permission from the Drug Controller General of India (DCGI) or the Indian National Technical Advisory Group on Immunization (NTAGI).

*PATH and ICMR hadn't sought mandatory permission from the Drug Controller General of India (DCGI) or the Indian National Technical Advisory Group on Immunization (NTAGI).

PATH wasn't even a registered legal entity when it began working with the ICMR.

*PATH wasn't even a registered legal entity when it began working with the ICMR.

DGAI culpable for dereliction of duty.

*DGAI culpable for dereliction of duty.

The Committee's report stated, 'PATH resorted to an element of subterfuge by calling the clinical trial as 'observational studies' or 'demonstration project' and recommended legal action against PATH (3). However, the Union Government of India decided legal action couldn't proceed based on the its assessment of the country's prevailing laws. Instead in 2014, it issued a warning letter to PATH (4).

The Committee's report stated, 'PATH resorted to an element of subterfuge by calling the clinical trial as 'observational studies' or 'demonstration project' and recommended legal action against PATH (3). However, the Union Government of India decided legal action couldn't proceed based on the its assessment of the country's prevailing laws. Instead in 2014, it issued a warning letter to PATH (4).