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Indian HPV vaccine trial should never have happened

Posted on behalf of Priya Shetty.

A human-papillomavirus (HPV) vaccine trial in India shut down in 2010 by the Indian government amid accusations of unethical behaviour has been further slammed by scientists who argue that it should never have been started at all.

A study published today in the Journal of the Royal Society of Medicine by Allyson Pollock, a public-health researcher at Queen Mary, University of London, and her colleagues, says that there is not enough evidence that cervical cancer affects enough women in India to warrant a vaccine.

The need for an HPV vaccine has been overhyped globally by non-governmental organizations (NGOs) pushing for its use, Pollock told Nature, especially given “the absence of strong epidemiological evidence and robust comprehensive cancer-surveillance systems in many countries”, including India.

In India, say Pollock’s team, cancer surveillance, registration and monitoring are so poor that it would be impossible to tell whether the vaccine reduced cervical-cancer rates. In addition, they say, incidence rates for cervical cancer are low compared to the rest of the world, and have fallen from around 43 cases per 100,000 in 1982–83 to around 22 per 100,000 in 2004–05.

The trial of more than 23,000 girls from Gujarat and Andhra Pradesh states was run by the international health NGO PATH. However, in a statement released shortly after the trial was halted, the NGO pointed out that the trial HPV vaccines used (Gardasil and Cervarix) were already licensed for sale in India, as well as in more than 100 other countries.

Even though PATH received appropriate ethics approval by the Indian government, Pollock feels “there should have been much more scrutiny of the decision to allow PATH to proceed with the vaccine trial in the first place,” she added.

Pollock feels so strongly that the HPV vaccine should not be used in India that she says its approval should be retracted. “It is like selling snake oil to the people, building on their fears and not their needs. There is no evidence of long-term benefit,” she told Nature.

The idea that NGOs are alone in pushing HPV or that poor cancer monitoring is a justification for not rolling out a vaccine seems hard to swallow though. For one thing, cervical cancer is the number one cancer affecting women in India, and kills 73,000 women each year; this number is set to rise to 115,000 in 2025.

Cancer rates may be poorly counted in India, but all developing countries suffer from a lack of robust data on disease burden, so it’s difficult to see how this justifies holding back a proven vaccine that the government will not be paying for (the vaccine is sold over the counter).

For the World Health Organization, which strongly backs the rollout of the vaccines in India, the evidence suggests that cancer rates are set to rise. Inaction is not really an option.

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    Robin Biellik said:

    I regret some of Dr. Pollock’s allegations regarding the PATH HPV demonstration project in India are incorrect and misleading. Donated vaccine was provided to young adolescent women in a demonstration project, not a trial. HPV vaccines are WHO-prequalified and recommended by WHO for global introduction. The GAVI Alliance is making HPV vaccines available to eligible poor countries at subsidized prices in view of experts’ consensus that they are safe, effective and highly valuable for disease control.
    The PATH HPV demonstration project was run in four countries during 2007-10 and funded by the Bill & Melinda Gates Foundation. All four countries’ ethics committees approved the project. Three country projects were completely successful, showing that HPV vaccine was met with very high levels of family and community acceptance, that vaccine delivery in school settings was feasible and practical, and there were virtually no adverse events. The project in India, whose design was identical to the other three projects, ran into political difficulties that had nothing to do with vaccines and immunization.
    Over 100,000 Indian women (of a total of over 250,000 globally) are estimated to die of cervical cancer every year. Poor Indian women do not have access to cervical screening services, so a vaccine is the ideal prevention mechanism for them. No researcher can justify obstructing their access to safe and effective HPV vaccines.

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