PATH Runs Into Vaccine Resistance In India

One of every four deaths from cervical cancer worldwide is a woman in India.

The cancer, which kills 250,000 women every year, is almost always caused by a sexually transmitted virus, human papillomavirus or HPV. There is a vaccine against HPV that studies have shown prevents this infection. India, it turns out, has more than its fair share of HPV and cervical cancer.

In 2009, Seattle-based PATH, with funding from the Bill & Melinda Gates Foundation, launched a project aimed at assisting India with introducing the HPV vaccine.

It didn’t work out as planned, as a report in Nature News this week — entitled Vaccines trial’s ethics criticized — describes in some detail.

The sub-headline of the Nature article, “Collapsed trial fuels unfounded vaccine fears,” is perhaps a bit closer to capturing the essence of this tale. But you could also say it was actually the unfounded fears that caused the collapse, which continues to fuel allegations of unethical research. An excerpt:

A scientific investigation has exonerated the vaccines but uncovered a more familiar problem in India: ethical irregularities.

Sounds bad, but I don’t think that was really the main problem here either. The problem, at least insofar as I can tell, is that the scientific and medical community basically sat on the sidelines and hoped to avoid controversy instead of dealing with it head on.

This week in Seattle, at the Pacific Health Summit, the focus is on how to expand the use of vaccines globally as one of the most cost-effective disease prevention technologies in the public health armory.

Yesterday at the meeting, one of the sessions was focused on dealing with public resistance, and fear of, vaccines. The media, as usual, was blamed for fanning the flames of anti-vaccine hysteria. This certainly was part of the problem in India with the PATH HPV vaccine project, but it probably was more a symptom than the cause — a point I tried to raise at the meeting yesterday, without much success.

Vivian Tsu was the PATH point person on this project. I talked to Tsu about what happened.

“It was a demonstration project,” said Tsu. The idea was to study how introducing the HPV vaccine into the standard immunization schedule in two Indian states, Gujarat and Andhra Pradesh, could be done cost-effectively, without disruption and in ways acceptable to the community. Some 23,000 young girls were vaccinated before the study was halted.

The allegations of unethical research practices reported in Nature, and elsewhere, Tsu said, are based on a government report (which has not been made public) that appears to confuse this logistical study with clinical research.

The vaccine, she noted, is not experimental. The project in India was not about testing vaccine safety or effectiveness but rather about finding the best way to incorporate it into the public health system.

But I’m getting ahead of myself.

This widely-cited-but-unreleased report is really more about the end of this story, a bit of political residue left over from the Indian government’s apparent attempt to dodge the issue by making it about something else. (Concerns about unethical research trials in India are legitimate, but not in this case.)

For more, visit Humanosphere.