Four tribal girls in Khammam district of Andhra Pradesh have died in the past one year after they were given three doses of vaccine of a multi-national company to prevent cervical cancer as part of drug trials by an American multinational pharmaceutical company in cooperation with the Andhra Pradesh government and with the approval of the Indian Council of Medical Research. None of the girls had any medical condition.
All of them incidentally were residents of government-run hostels for tribal children.
Civil society organisations were up in arms over the shroud of secrecy under which the 'demonstration trials' were conducted, the misleading claims of life-long protection by the vaccine, and a 'cover-up' of the side effects suffered by a large number of the girls and subsequent death of four of them. As a memorandum submitted by 70-odd NGOs and individuals to Union Health Minister said, "It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit-making private company."
The Centre suspended the trials last Wednesday but Director General of Indian Council of Medical Research Dr V M Katoch insists that the girls died of extraneous reasons and not due to the vaccine. He said he was suspending trials of cervical cancer vaccine Gardasil as a precautionary measure. "I decided to suspend the trials because I wanted to first prove to the public that the allegations are false. I also want the general public to know that all ethical guidelines would be followed in this trial," he said.
Activists believe this is 'ostrich-like' behaviour and want an investigation done into the deaths by independent body since the state governments which have shrugged off all responsibility, are not likely to be objective.
The drug 'demonstration trials' were being implemented in Khammam district of AP and Vadodara district of Gujarat. In both states, the India branch of the international NGO PATH was overseeing the implementation of the demo trials. Girls between the ages of 10 and 14 were administered three doses of the cervical in July, October 2009 and February 2010.
The AP government denied the deaths were related to vaccine and that they were suicides by the children. This is flatly denied by the parents of the girls who insist that there was no indication that their daughters were either having problems or that they were suicidal.
Dr B. Jaikumar, district immunity officer, Khammam, who heads the implementation of this programme insisted that "The three post-mortems show that these are cases of suicide. The girls who were administered this vaccine showed mild side effects such as headaches and swellings but nothing serious," he maintained.
However, Dr Rukmini Rao whose Gramya Resource Centre for Women has been working among tribals of Nalgonda and Khammam for more than a decade confirmed that as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, head aches and mood swings.
There have also been reports of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps. "We learnt that one of the girls died due to convulsions while another had an epileptic fit. But the doctors there are passing these deaths off as cases of suicide," said Rukmini Rao.
The claims of the NGO and the government health officials that the permission of parents was taken in writing to administer the vaccine are questioned by activists. In the first place, the parents are too poor and illiterate to understand the implications Activists point out that this claim too was false as the vaccine had manifested severe side effects including deaths in the US, UK and other European countries.
Rukmini Rao asked if the vaccine was really so effective why was it not tried out in elite schools in urban areas,” she asked. "Now that the hoo-ha over cervical cancer has died down in the western countries the manufacturers are trying to create a market in India," she said.