PATH encounters vaccine foes, charges of unethical research 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.)

The controversy began in the fall of 2009 when a small number of young girls (it varies in the reports I’ve read from four to seven girls) died after receiving the vaccine.

Two women’s rights groups in Andhra Pradesh suspected their deaths were caused by the vaccine and pressed the issue. A politician got involved, demanding answers. And yes, some media aggressively reported all these questions and suspicions — implying or just claiming the deaths were related.

“In April 2010, immunizations were suspended,” Tsu said. No more young girls got the vaccine through the government health programs, she said, and plans to expand HPV vaccination to other states were halted. “And they all remain suspended today.”

Scientists eventually determined the deaths were unrelated to the vaccine. The media has moved on to other stories. But as a result of the suspension, many young Indian girls who could have avoided HPV infection are being infected and will, years later, be at high risk for cervical cancer.

“The vaccine is still available on the private market in India and we’re told sales are growing,” Tsu said. “That’s fine for families with money. This project was to make sure poor girls were protected.”

Tsu noted that in the communities they studied few parents were put off by the media reports claiming the deaths were related to the vaccine, she said. Girls kept coming in to get their shots throughout the controversy.

What really killed this project, Tsu said, was the lack of a pro-active response by the Indian scientific and medical community, as well as the political leadership, to directly confront the crisis and allegations.

“Nobody came forward to do that,” she said. “The critics and the media just had a free hand without anyone in the scientific, medical or political community challenging them.”

It was, in a word, a one-sided story.

The media carried the message and caused damage, but those in positions of power and authority who stood by silently on the sidelines shoulder perhaps even more responsibility for this debacle. As they say, don’t shoot the messenger.

Or go ahead and shoot the messenger. It can be satisfying and even justified. But you may not have solved the problem.

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About Author

Tom Paulson

Tom Paulson is founder and lead journalist at Humanosphere. Prior to operating this online news site, he reported on science,  medicine, health policy, aid and development for the Seattle Post-Intelligencer. Contact him at tom-at-humanosphere.org, follow him on Twitter @tompaulson and/or send a comment below.

  • Marian Wheatley

    A slight legal problem PATH, its called “informed consent” , something you seemed to have overlooked in your zealousness to perform clinical trials on poor people in the 3rd world.  Thank goodness the real storey is getting out because of courageous informative journalists. If you really are as moral as you say you are, you should be looking into this yourselves, not denying you ever did anything wrong.