British researchers warn India on cervical cancer vaccine trial

Dinesh C. Sharma | Mail Today | New Delhi, June 22, 2012

Scientific evidence does not support rolling out vaccines against the Human Papilloma Virus (HPV) in the general population, British researchers have warned India. HPV is linked to cervical cancer.

This comes in a study published in the Journal of the Royal Society of Medicine on Thursday, in the backdrop of intense lobbying to introduce the vaccines in government-funded programmes.

Pending a final decision, the vaccines are being aggressively promoted through doctors, social media and publicity campaigns by drug companies â GSK and Merck.

PATH, a charity supported by Bill Gates, is also keen to promote the two vaccines in India. It was involved in clinical trials of the vaccine among tribal girls in Andhra Pradesh and Gujarat, but the project was stopped following the death of four girls after vaccination.

In absolute numbers, cervical cancer may be a major killer in India but existing data show that incidence rates for cervical cancer are low and decreased from around 43 cases per 100,000 in 1982-83 to around 22 per 100,000 in 2004-05.

Brazil and Zimbabwe are reported to have around twice this rate.

“Neither the epidemiological evidence nor the current cancer surveillance systems justify general rollout of a HPV vaccination programme either in India or in the two states where PATH was conducting its research,” the study observed.

Such vaccination, the study added, should be done only in areas where there is strong epidemiological evidence and which have the necessary surveillance and monitoring in place.

The study led by Allyson Pollock found that cancer surveillance, registration and monitoring in India in general â and specifically in Gujarat and Andhra Pradesh â is incomplete. In such a situation, it would be impossible to tell whether the vaccine would be successful in preventing cervical cancer.

The existing system of cancer registries is not adequate because they are not complete or comprehensive in their coverage for every region.

Moreover, cancer registries give data about cancer cases and not about HPV prevalence, which is sought to be targeted by the new vaccines, the study pointed out.

“Current data on cervical cancer incidence does not support PATH’s claim that India has a large burden of cervical cancer or its decision to roll out the vaccine programme,” Pollock said.

“The lack of information is important because it means that World Health Organisation criteria for monitoring the effectiveness of the vaccine cannot be fulfiled,” she added.