Judges demand answers after children die in controversial cancer vaccine trial in India
Tribal girls were given shots of cervical cancer vaccines during trial
Children given Merck’s Gardasil and Cervarix vaccines
Petitioners also asked judges to investigate trials of new drug Gardasil 9
Drug has allegedly caused side-effects in children as young as nine
Investigation claims children were used as unwitting human guinea pigs
Supreme Court has given the government one month to provide answers
In 2009, tribal children from the Khammam district in Andhra Pradesh were administered with a Human Papilloma Virus (HPV) vaccine meant for cervical cancer. Around 16,000 girls between the age of 9-15 years were given three shots of vaccine, (manufactured by Merck) by the state health department. The girls were told that they were being given “well-being” shots. The incident started getting attention when some months later, several girls’ health deteriorated and the following year, five of them died. Two such similar cases of deaths were reported from Vadodara, Gujarat, where 14,000 tribal children were also vaccinated with the HPV vaccine Cervarix, made by Glaxo SmithKline.
Around the same time when these incidents were reported, young girls were hospitalised in northern Colombia with similar symptoms. Coincidentally, these girls had been given doses of vaccine too.
Skeletons started tumbling out when an NGO visited Andhra Pradesh. Health activists from the NGO Sama visited Khammam in March 2010 and found out that more than 100 girls were having epileptic seizures, stomach aches, headaches and mood swings. The girls also complained about early menstruation, heavy bleeding and menstrual cramps. Sama raised the issue that these students were made guinea pigs on the pretext of providing healthcare. The illiterate parents were kept in the dark about the real vaccine, and most of them gave their consent in the form of thumb prints.
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.
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).
Public recognition of problems with this trial started with the reported death of 7 girls. This led to immediate suspension of the trial in 2010 even though it was supposed to run until 2011. Investigations showed these deaths weren’t directly connected to the vaccines (see table from the initial official investigation report, 1).
However, investigations triggered by these deaths instead uncovered serious violations of the process of informed consent (see official investigation reports below from 1, see also 2). 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. In the course of Government of India (GOI) investigations, the trial investigators ‘were asked to submit 100 consent forms, chosen randomly, for both AP and Gujarat for independent verification’ (1). These consent forms turned out to have several problems (see reports below from 1).