Do cervical cancer data justify HPV vaccination in India? Epidemiological data sources and comprehensiveness

Abstract

The Indian government suspended research in April 2010 on the feasibility and safety of human papillomavirus (HPV) vaccine in two Indian states (Andhra Pradesh and Gujarat) amid public concerns about its safety. This paper describes cervical cancer and cancer surveillance in India and reviews the epidemiological claims made by the Programme for Appropriate Technology in Health (PATH) in support of the vaccine in these two states. National cancer data published by the Indian National Cancer Registry Programme of state registry returns and the International Agency for Research on Cancer cover around seven percent of the population with underrepresentation of rural, northern, eastern and north-eastern areas. There is no cancer registry in the state of Andhra Pradesh and PATH does not cite data from the Gujarat cancer registries. Age-adjusted cervical cancer mortality and incidence rates vary widely across and within states. National trends in age standardized cervical cancer incidence fell from 42.3 to 22.3 per 100,000 between 1982/1983 and 2004/2005 respectively. Incidence studies report low incidence and mortality rates in Gujarat and Andhra Pradesh. Although HPV prevalence is higher in cancer patients (93.3%) than healthy patients (7.0%) and HPV types 16 and 18 are most prevalent in cancer patients, population prevelance data are poor and studies highly variable in their findings. Current data on HPV type and cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine programme. In the absence of comprehensive cancer surveillance, World Health Organization criteria with respect to monitoring effectiveness of the vaccine and knowledge of disease trends cannot be fulfilled.

Awareness of carcinoma cervix in nursing personnel of a tertiary care institute, Mumbai, India

“…PATH and the Indian government are investigating whether to implement a HPV vaccination program. 5 Of all the female genital tract cancers, cervical cancer is a deadly disease once in the invasive stages, nevertheless, it is the only preventable cancer, if detected at its early stages. Population screening with Pap smear is an important secondary preventive measure for cervical cancer helping in a high-cure rate amongst patients.…”

Author's Response: HPV vaccination in India

“…2 The Lancet paper cited by Forman et al reporting on mortality rates is highly problematic for a number of reasons.…”

“…1,4,5 They attribute this decrease to family planning, education and socioeconomic improvement combined with programmes for screening and early detection. In the absence of highquality comprehensive cancer surveillance it is not possible to test these claims nor to justify the implementation of human papillomavirus (HPV) vaccination programmes on public health grounds.…”

“…Why conduct safety and feasibility studies if efficacy and indications for the vaccine are unknown. 1 PATH state that they rely on GLOBOCAN data and claim that rural populations have a higher incidence. Our analysis shows that GLOBOCAN and other data have important gaps and that Indian registries underrepresent the rural population and exclude many regions of India.…”

“…For example, they do not acknowledge that the decline in rates was an urban phenomenon, and that it was not reflected in the one rural registry (Barshi) 2 . To understand disease burden PATH relied upon the WHO's GLO-BOCAN database 3 , which estimates that India has the highest absolute number of cervical cancer cases in the world.…”