Saturday, June 30, 2012
India - Researchers Raise Doubts Over HPV Trial In India
New research has raised further questions about a HPV vaccine trial in India that has since been halted and become the subject of an investigation by the Indian government.
Research published in the Journal of the Royal Society of Medicine has raised further questions about a recent human papilloma virus (HPV) vaccine trial in India.
The trial, which has now been halted and is the subject of an investigation by the Indian government, was examining the safety and feasibility of a vaccine against the virus associated with cervical cancer.
The new study by researchers at Queen Mary, University of London and the University of Edinburgh suggests that lack of data on cervical cancer in India does not support a trial of the vaccine to prevent the disease.
The trial was run by the international health charity PATH and involved more than 23,000 girls from the Gujarat and Andhra Pradesh states. A committee of scientists commissioned by the Indian government to look into the trial said that the study involved a number of serious ethical violations.
The research by Professor Allyson Pollock and colleagues examined a series of claims made by PATH about cervical cancer in India, among them that “in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide.”
They found that cancer surveillance, registration, and monitoring in India in general – and specifically in the Gujarat and Andhra Pradesh regions – was incomplete, meaning that it would be impossible to tell whether the vaccine would be successful in preventing the disease.
In addition, figures that exist for India show that incidence rates for cervical cancer are low and fell 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 the rate.
“This trial has clearly raised serious concerns for the people and government of India. The aim of our study was to look at whether data on cervical cancer in the country justify the introduction of HPV vaccination. We found that current data on 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 program,” Pollock explained.
Pollock said that the lack of information is important because it means that World Health Organization criteria for monitoring the effectiveness of the vaccine cannot be fulfilled.
Furthermore, neither the epidemiological evidence nor current cancer surveillance systems justify the general rollout of an HPV vaccination program in India or in the two states where PATH was conducting its research.
Pollock added that the burden of cervical cancer in India was also linked to other major health concerns, such as primary care, malaria, maternal anemia, and malnutrition.
“The HPV vaccine which is among the most expensive vaccines on the market is not justified as a health care priority for India,” she said.
The article can be found at: Mattheij I et al. (2012) Do cervical cancer data justify HPV vaccination in India? Epidemiological data sources and comprehensiveness.
Source: Queen Mary, University of London