Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

In 2009, several schools for tribal children in Khammam district in Telangana — then a part of undivided Andhra Pradesh — became sites for observation studies for a cervical cancer vaccine that was administered to thousands of girls aged between nine and 15. The girls were administered the Human Papilloma Virus (HPV) vaccine in three rounds that year under the supervision of state health department officials. The vaccine used was Gardasil, manufactured by Merck. It was administered to around 16,000 girls in the district, many of whom stayed in state government-run hostels meant for tribal students.

Months later, many girls started falling ill and by 2010 five of them died. Two more deaths were reported from Vadodara, Gujarat, where an estimated 14,000 children studying in schools meant for tribal children were also vaccinated with another brand of HPV vaccine, Cervarix, manufactured by GSK. Earlier in the week, the Associated Press reported that scores of teenaged girls were hospitalised in a small town in northern Colombia with symptoms that parents suspect could be an adverse reaction to Gardasil.

A standing committee on health and family welfare that investigated the irregularities pertaining to the observation studies in India tabled its report a year ago, on August 30.

The committee found that consent for conducting these studies, in many cases, was taken from the hostel wardens, which was a flagrant violation of norms. In many other cases, thumbprint impressions of their poor and illiterate parents were duly affixed onto the consent form. The children also had no idea about the nature of the disease or the vaccine. The authorities concerned could not furnish requisite consent forms for the vaccinated children in a huge number of cases.

The committee said it was "deeply shocked to find that in Andhra Pradesh out of the 9,543 [consent] forms, 1,948 forms have thumb impressions while hostel wardens have signed 2,763 forms. In Gujarat, out of the 6,217 forms 3,944 have thumb impressions and 5,454 either signed or carried thumb impressions of guardians. The data revealed that a very large number of parents or guardians are illiterate and could not even write in their local languages, Telugu or Gujarati."

Earlier this month, taking a serious view of the death of seven tribal girls in the context of the observation studies, the Supreme Court asked the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) to explain how permissions were given.

The SC bench of justices Dipak Misra and V Gopala Gowda asked the Centre to produce relevant files that pertained to the grant of licence for trial of the HPV vaccine in India. The court also asked the Centre to appraise it of steps taken on the report of the parliamentary committee.

Shoddy Investigations

When a team of health activists from an NGO that specializes in women's health named Sama visited Khammam in March 2010 on a fact-finding mission, they were told that as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, headaches and mood swings. The Sama report also said there had been cases of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps among many students. The standing committee pulled up the relevant state governments for the shoddy investigation into these deaths. It said it was disturbed to find that "all the seven deaths were summarily dismissed as unrelated to vaccinations without in-depth investigations...the speculative causes were suicides, accidental drowning in well (why not suicide?), malaria, viral infections, subarachnoid hemorrhage (without autopsy) etc."