Pharmaceutical International News - June 2012
Indian HPV Vaccine Trial Flawed
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 21/06/2012 - 04:10:00
A new study has further challenged the way a recent HPV vaccine trial was carried out in India.
Now brought to an end, the HPV vaccine trial aimed to establish that the product being tested was both effective and safe but it's now being looked into by the Indian government.
Conducted by PATH - an international health charity - the HPV (human papilloma virus) vaccine trial involved over 23,000 female participants. Already, a scientific committee contracted by the government in India has highlighted how, on several fronts, this trial was ethically flawed.
Indian Vaccine Trial
Now, representatives from the University of Edinburgh and Queen Mary, University of London have examined the background to the Indian vaccine trial's introduction and the monitoring that took place while it was in motion. Specifically, they probed a number of PATH's claims, including one stating that ‘in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide.'
Led by Professor Allyson Pollock, the researchers discovered gaps in the way India deals with cancer data, so much so that it wouldn't be possible to judge the HPV vaccine's true success rate.
They also pointed out that India's level of new cervical cancer diagnoses has actually dropped, with about a 50 per cent decrease between 1982 and 2005. That's approximately half the numbers quoted for other nations, chiefly Zimbabwe and Brazil.
Indian HPV Vaccine
"This trial has clearly raised serious concerns for the people and government of India", Professor Pollock stated, in comments on the Indian HPV vaccine trial. She continued: "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 programme. The lack of information is important because it means that World Health Organisation criteria for monitoring the effectiveness of the vaccine cannot be fulfilled.
"Neither the epidemiological evidence nor current cancer surveillance systems justify the general rollout of an HPV vaccination programme in India or in the two states where PATH was conducting its research."
The University of Edinburgh and Queen Mary, University of London's research features in a piece published on 21 June by the Journal of the Royal Society of Medicine.
Image copyright Grook Da Oger - courtesy Wikimedia Commons
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