Cervical cancer vaccine study in ethics glare

New Delhi, April 8: An Indian government study to vaccinate thousands of girls in Andhra Pradesh against a sexually-transmitted virus that can cause cervical cancer has breached guidelines for ethics in medical research, women’s groups said today.

About 13,000 girls between 10 and 14 years had received a vaccine against the human papilloma virus (HPV) in Khammam district between August 2009 and January 2010. The study was conducted jointly by the Indian Council of Medical Research (ICMR), a US-based non-government organisation called Path and the Andhra government.

The vaccine, already approved for commercial sale in India, protects against the HPV virus that accounts for about 70 per cent of cases of cervical cancer — the most common cancer among women in India. While most women who get cervical cancer are in their 40s or older, studies suggest the HPV vaccine is most effective if given to young girls. Millions of girls in North America, Europe and Australia have received the vaccine since it was approved in the US about five years ago.

Drug regulators have certified the vaccine as safe. Four girls who received the vaccine in the Andhra study have died and between 30 and 100 have experienced side effects such as dizziness, headache or abdominal pain. But health authorities have said the deaths are not linked to the vaccine.

Senior ICMR and Path officials have said the study in Andhra with a parallel arm in Baroda, Gujarat, is intended generate data that will allow India to determine whether it is cost-effective to introduce HPV vaccine in a public-funded programme.

The officials concede that because the vaccine was introduced less than a decade ago, it is too early to say whether it prevents cervical cancer itself, but HPV vaccines have been shown to prevent 90 per cent of pre-cancerous cervical lesions.

But women’s groups have said their investigations show that health staff involved in the study violated guidelines for ethics by providing misleading information to the girls’ parents or by short-circuiting informed consent procedures.

The ICMR’s own guidelines require that the study participants should provide informed consent after understanding the purpose of the study, the nature of the vaccine, the potential benefits and possible side effects.

A state immunisation official involved in the study and a Path spokesperson in New Delhi told The Telegraph that informed consent had been obtained from all parents whose girls received the vaccine.

However, field visits by a women’s health group called Sama and the All India Democratic Women’s Association have shown that informed consent had not been sought from several parents. In one residential school, a hostel warden was asked to sign for several hundred girls, N. Sarojini, the Sama director, said. In another school, girls were given forms and asked to get it signed by their parents, she said. “This is a mockery of the informed consent procedures,” said Brinda Karat, a member of the Rajya Sabha who visited the study area and met school staff, parents and the girls last week.

The women’s groups said information sheets claimed to have been circulated by health staff to parents contain information that appears designed to coax parents into accepting the vaccine, including a statement that the vaccine could provide life-long immunity.

The foreign collaborator Path told The Telegraph that the consent documents “were based on ICMR guidelines” and had been approved by multiple ethics review committees at the government-run Regional Cancer Centre in Hyderabad and the health minister’s screening committee, among others.

India’s top health research official said the ICMR’s role was confined to developing the protocol (rules) for the study and to participate in the analysis of the results. “We have not gone into the ethics documents — that was left to local ethics committees,” said Vishwa Mohan Katoch, the ICMR director-general. “We would never endorse any violations.”

The study is important because it will allow India to assess the vaccine in a public health programme, Katoch said. He said he was unaware of specific ethics violations in the study, but “the rights of the people should be paramount”.

The women’s groups have called for a suspension of the study and demanded an inquiry. “Who’s accountable for this?” Karat said. “We have no answer yet.”