The human papillomavirus

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[NEW DELHI] The Indian Council of Medical Research (ICMR) has advised two state governments to suspend a vaccination programme against cervical cancer following controversy over violation of guidelines during trials.

ICMR director-general Vishwa Mohan Katoch confirmed to The Hindu this week (7 April) that the council had received "complaints of violation of guidelines and exploitation of people from civil society groups some months ago, following the death of four girls who were given this vaccine".

Cancer of the cervix (the lower narrow portion of the uterus) is caused by the sexually transmitted human papillomavirus (HPV) and affects nearly 500,000 women each year, mostly in developing countries. Two international pharmaceutical firms, Merck and GlaxoSmithKline, have developed vaccines against HPV that were introduced in the United States in 2009.

That year India launched a two-year 'demonstration' project on the vaccines — run by the ICMR, the state governments of Andhra Pradesh and Gujarat, and US-based non-governmental organisation PATH International — involving about 32,000 girls aged ten to 14 years old.

During this time, India's drug regulatory authority cleared the vaccines for commercial marketing and Indian TV channels broadcasted advertisements urging young girls to use anti-HPV vaccines.

But the trials came under the spotlight after the deaths of four girls were reported last month (March). Andhra Pradesh's state health minister denied charges by women activist groups linking the deaths to HPV vaccination.

At a press conference this week (7 April), groups including Saheli, Sama and the All India Women's Democratic Association also said some of the vaccinated girls developed complications such as headache, stomach disorders and early onset of menstruation.

They said the study did not follow procedures for informed consent from trial participants, violated Indian rules that state drugs and vaccines should be tested in children only after testing on adults, and used economically and socially disadvantaged sections of society as subjects. The groups submitted a letter to India's health minister Ghulam Nabi Azad last week (4 April).

"The Indian government licensed the vaccines with no evidence for the [cervical cancer] disease burden in the country; or for the vaccine efficacy, or whether it offered protection against all types of cervical cancer in India," said Madhavi Yennappu, a vaccine specialist at the National Institute for Science, Technology and Development Studies in Delhi.

"In such post-licensing studies, the government assumes the vaccine is safe, effective and useful. But there is no national data on prevalence of cervical cancer, how many of these cases are due to HPV, and how many of the HPV strains in India are covered by the vaccine," said Ritu Priya, associate professor at the Centre for Social Medicine and Community Health at the Jawaharlal Nehru University, Delhi.

"Such observation studies help circumvent some of the rigorous procedures of clinical trials," she added.