By Anita Jain, India editor, BMJ (open access commentary)
The path (no pun intended) to adoption of human papillomavirus (HPV) vaccine is mired in controversy again. Back in 2010, an HPV vaccine study conducted in the states of Andhra Pradesh and Gujarat by the international non-profit Program for Appropriate Technology in Health (PATH) was stalled amid allegations of ethical violations. More than 23 000 girls aged 10-14 years were given the HPV vaccine under this project, which health activists assert was “tantamount to using Indians as guinea pigs” (doi:10.1136/bmj.c1775).
A parliamentary panel investigating the matter confirms serious shortcomings in the protocol and execution of this study. In a report submitted earlier this month, they document misleading information given to parents about the benefits of the vaccine, and perpetuation of a false impression that the vaccination program was a government initiative. Further, the study targeted a vulnerable population of rural and tribal adolescent girls, and lacked necessary surveillance systems to monitor adverse events (doi:10.1136/bmj.f5492). The panel slammed the Indian Council of Medical Research for acting hand-in-glove with PATH in circumventing standard protocols for clinical trials and vaccine approvals in the country.
Moving beyond the regulatory gaps exposed by this particular study, we do need hard evidence on the protective efficacy and cost effectiveness of HPV vaccination in preventing cervical cancer, to consider its roll out as a national programme. With more deaths from cervical cancer annually than any other country in the world (doi:10.1136/bmj.f3108), the debate is central to India.
We bring to you a clinical review of the evolving evidence on primary prevention of cervical cancer (doi:10.1136/bmj.f4781). Henry Kitchener and Emma Crosbie explore the improvements offered by a dual approach of HPV vaccination and HPV based cervical screening over exfoliative cytology by Pap smear alone, as practised in India. In a linked podcast interview (www.bmj.com/podcast/2013/08/16/hpv-testing-preventing-cervical-cancer), Kitchener shares that persistent HPV infection is the principal causative agent for cervical cancer. However, there is only a 1-2% chance of developing cervical cancer in the absence of screening and vaccination, making it “a very rare complication of a relatively common infection.” The review presents evidence from large clinical trials, including a study from India, and national immunisation programmes elsewhere which demonstrate effectiveness of HPV vaccination in preventing pre-cancerous cervical lesions. Crosbie cautions that this is exciting early data but there is still a long way to go in determining efficacy of the vaccine in reducing cervical cancers and the duration of protection offered.
So, is this for us?
Even as drug companies cut the price of HPV vaccines, Kate Elder, vaccines policy adviser at Médecins Sans Frontières, expresses disappointment that the costs remain “unjustifiably high” for low income countries (doi:10.1136/bmj.f3025). It is important therefore, to weigh the benefits of vaccination against indigenous screening methods such as visual inspection with acetic acid by primary health workers, which offers promise as a simple, low cost and effective intervention in India (doi:10.1136/bmj.f3935). Allyson Pollock, author of a review on HPV vaccination in India, contends that a roll out of the vaccine is completely irrational from a public health perspective (doi:10.1136/bmj.e4390), and poses three vital questions for the government to consider: “whether it [HPV vaccine] works, whether it is needed, and whether it is a health priority.”
Citation: BMJ 2013;347:f5634