The HPV Vaccine: Science, Ethics and Regulation

A recent civil society-led investigation has highlighted serious ethical violations in a trial of the Human Papilloma Virus vaccine on girls in Khammam district in Andhra Pradesh. The findings are presented along with a review of clinical trials of the hpv vaccine in India and an analysis of the Drugs and Cosmetics Act and Rules. Together they illustrate how the promotional practices of drug companies, pressure from powerful international organisations, and the co-option of, and uncritical endorsement by, India’s medical associations are influencing the country’s public health priorities. On 7 April 2010, the government called a halt to trials of the Human Papilloma Virus (HPV) vaccine in the country. According to a press report, “In the wake of reports of violation of ethical guidelines and exploitation during the ‘clinical trials’ of HPV (Human Papilloma Virus) vaccine, meant to prevent cervical cancer among women, the Centre on Wednesday advised the state governments to suspend the vaccine programme until the issue is settled” (Dhar 2010a). On 29 April, V M Katoch, Secretary, D epartment of Health Research and Director General of the Indian Council of Medical Research (ICMR), admitted to the Parliamentary Standing Committee on Health that the “Drugs Controller General of I ndia’s guidelines had not been adhered to in the clinical trial of the Human Papilloma Virus (HPV) vaccine”, and a committee was constituted to inquire into the demonstration projects (Thacker 2010). Both the announcement and the statement came after strong opposition by civil society groups and a Member of Parliament (Parliament Proceedings 2010)1 to what were described as “demonstration projects” of the HPV vaccine2 being conducted in the country. Civil society groups in India have been voicing their concerns regarding the safety and efficacy of the two HPV vaccines; the unethical promotion of the vaccines in the private and public sectors; the public health implications of their administration; the need to investigate reported deaths and adverse events post vaccination; and the consequences if the vaccines were introduced into the country’s universal immunisation programme (UIP). Two memoranda have been submitted to the union minister of health and family welfare (MOHFW) enumerating these concerns and calling for a halt to the demonstration projects (Dabade et al 2010; Jan Swasthya Abhiyan et al 2010). In March 2010, a team of women’s rights activists3 visited one of the vaccination sites in Bhadrachalam mandal, Khammam district, Andhra Pradesh (AP), to understand the ground realities of the project. In particular, they sought to look at the nature and procedures of taking consent and providing information to the girls and their parents, and the availability of the health infrastructure required to support cancer screening and prevention. The team visited residential schools, hostels and primary health centres (PHCs) where girls were vaccinated. Interviews were conducted with vaccinated girls, hostel wardens, schoolteachers, PHC staff, local activists from adivasi networks and women’s groups. The team also interacted with the parents of one of the girls who died in January 2010, following the third dose of the vaccine. A look at the findings of this visit, along with the recent admissions by the MOHFW and the ICMR about the nature of the projects and other related concerns, suggests that these projects – which were in fact research – violated existing ethical guidelines on clinical research, as well as child rights. These violations include – but are not limited to – testing on vulnerable and marginalised groups (particularly paediatric populations), who are not likely to benefit from the results of the research, and without taking their proper informed consent or assent. In addition, a scrutiny of other trials on the HPV vaccine and of ethical and regulatory documents highlights problems in the implementation of Schedule Y of the Drugs and Cosmetics Act (DCA) regarding requirements for clinical trials, and the interpretation of the law by the Drugs Controller General of India (DCGI). Trials conducted for regulatory requirements may be insufficient from a scientific point of view. Further, there is no harmonisation between Schedule Y of the DCA, the ICMR’s ethical guidelines on biomedical research on human participants, and the World Medical Association’s Declaration of Helsinki. Schedule Y is legally binding on clinical trials in India. While the other two documents are not legally binding, Schedule Y requires that clinical study The authors would like to acknowledge Vrinda Marwah from Sama for her inputs.