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
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