The Trial Of A Vaccine Trail
By Sarojini N. and Anjali S.
Bhadrachalam (Women's Feature Service) - "We felt we were fortunate to be getting this vaccine for free, which would be out of the reach of our daughters after the project. Moreover, all of us were told that if the girls take this injection, they will not get garbasanchi (uterine) cancer. Since cancer is a dreaded disease all of us felt this injection will be good for our daughters. However, once they started complaining of headaches, stomach aches, we realised that we were not given complete information." - A parent in Bhadrachalam.
On July 9, 2009, the Andhra Pradesh Ministry for Health and Family Welfare, in association with the Indian Council of Medical Research (ICMR) and PATH International, a US-based NGO, launched what it termed a 'demonstration project' for vaccination against cervical cancer.
The vaccine, against the Human Papillomavirus (HPV), was administered to 14,000 girls between the ages of 10 and 14 in three mandals - Bhadrachalam, Kothagudem and Thirumalayapalem - of Khammam district in Andhra Pradesh (AP). The vaccine used was Gardasil, manufactured by Merck Sharpe and Dohme, the Indian subsidiary of Merck and Co. Inc., a US-based pharmaceutical company.
In a similar project, on August 13, 2009, the Gujarat government administered three doses of the HPV vaccine to 16,000 girls in the same age group in three blocks of Vadodara district - Dabhoi, Kawant and Shinor.
So far, there have been six reported deaths following the vaccination. A team of women's rights and health activists from three organisations - Sama, Jan Swasthya Abhiyan and Anthra - visited Bhadrachalam in AP to conduct a fact-finding inquiry between March 27 and 30, 2010. Their investigation has shown the so-called 'demonstration project' to be a calculated, multi-level violation of all existing protocols on clinical trials, and a breach of child rights.
The children selected were from four social groups - Scheduled Tribes, Scheduled Castes, Muslims and Other Backward Classes - and came from impoverished backgrounds. The majority were tribal children, whose parents were agricultural workers. Some girls were from families that have been displaced by conflict in the neighbouring state of Chhattisgarh - circumstances that only served to compound their vulnerability.
In Bhadrachalam, most vaccinated girls were residents of 'ashram paathshalas' (boarding schools). Their selection is striking, given that their parents - who live separately from them - could not monitor and respond to any adverse developments in their children's health. Moreover, this has allowed providers to conveniently sidestep the provision of parental consent.
So, it's clear that the 'target group' was powerless to question the motive of the 'project', or the procedures adopted.
The vaccine was administered through a camp approach in hostels and school campuses. In many instances, the wardens of the residential schools and hostels were asked to provide consent or permission for the vaccination, while parents themselves were not informed. The very nature of this project appears to be in violation of all ethical norms since a warden - whether a legal guardian or not - cannot be allowed to provide consent on behalf of hundreds of children without consulting their parents, who are their natural guardians.
On the basis of the interactions, it appeared that the 'consent' was used mainly in the case of non-residential schools. The children were asked to get the consent form signed by their parents, which is in violation of the designated protocol for obtaining consent. Informed consent requires the 'researcher' to directly provide information mandatory for consent to the person (s), in this case the parents, which was not done.
In the schools and hostels, the selected girls were given HPV Immunization Cards, which were in English and which neither the girls, nor their parents, were able to read. Further, the interactions with the wardens, teachers and students did not at all imply that they understood the vaccination initiative as a study. Rather, they believed it to be a public immunization programme and had no idea that they were part of a research project. To them, the government was providing an expensive vaccine free of cost, which was otherwise unaffordable and which would prevent 'uterine' or 'cervical cancer'. In fact, they were not even aware that they could choose whether they wanted to participate in the study or not, and that the administration of the vaccine was contingent on their consent.
Many parents brought their daughters to the vaccination camps themselves when they heard about the project. As one mother said, "Since it was a vaccine being given by the government, we all trusted it blindly and considered it reliable, like any other vaccine that is given in the immunization programme."
Throughout the project period - July 2009 to February 2010 - the girls and their parents were told - or rather misinformed - that the vaccination would prevent uterine or cervical cancer. The HPV Immunization Card states that the "HPV vaccine prevents HPV infection". However, the current vaccine prevents infection resulting from just two of the HPV subtypes (16 and 18) and is not a substitute for cervical cancer screening. All women, including those who are vaccinated, need to undergo regular pap tests. This is clearly stated on the official Gardasil website.
Following the vaccination, many girls suffered from stomach ache, headache, giddiness and exhaustion. There were also reports of the early onset of menstruation, heavy bleeding, severe menstrual cramps, extreme mood swings, irritability, and uneasiness. Many girls, suffering from these adverse effects, sought treatment in private clinics or from local healers. There was no systematic follow up or monitoring carried out by the providers. In fact, there was no space allocated in either the consent forms or the cards to record the addresses of the girls, in case any follow up was needed.
Participants were verbally informed that the vaccine will provide life-long protection, has no side-effects and will not affect fertility. Factually, however, there is lack of conclusive data regarding the length of immunologic protection the vaccine confers against HPV subtypes 16 and 18. Since the long term efficacy and protection by the vaccine is unknown, it cannot be claimed that even 60 to 70 per cent protection will be achieved. It is also unclear if, when and how booster shots will be required.
While the project was carried out under the banner of National Rural Health Mission (NRHM), there was no mention of it in the NRHM mission statement. What makes the situation even more untenable is the fact that medical facilities in the region are grossly inadequate. Pap smear facilities, although a must for even those vaccinated against HPV, are not available in government facilities in the area. The entire tribal mandal of Bhadrachalam does not have even one gynaecologist.
Though the state government has claimed that the deaths were not due to the vaccine trials, the parents of Kudumula Sarita, who died in January 2010, believe that their daughter died because of the vaccination. They denied that she killed herself by consuming pesticide, as the authorities have declared.
Although the trial has been suspended temporarily and an inquiry committee has been set up, the composition of the committee leaves much to be desired and is far from representative.
BACK TO THEME OF THE MONTH
Isn't it time then to heed Sarita's parents' call? "We lost our child, and we know the pain and the agony of that loss. We don't want any other child to die. We don't want any other parent to suffer," they said.
(The writers were part of the inquiry team. They would like to acknowledge the contribution of Vrinda, Aastha and Deepa in writing this feature.)
(©Women's Feature Service)