If you think the debate over vaccines in the United States can sometimes be a little wacky, take a look at India.
And if you think irresponsible politicking and journalism can’t kill, think again.
Seattle-based PATH, which in 2009 attempted to test the logistics of expanding the use of HPV (human papilloma virus) vaccine in girls to prevent cervical cancer, has been castigated by critics for ‘unethical human experimentation’ – even though the vaccine is hardly experimental – and is now the target of two lawsuits in India.
One politician, capitalizing on the controversy, even called for PATH to be entirely expelled from India.
Meanwhile, the international biomedical research community, including the U.S. National Institutes of Health, and the pharmaceutical industry have suspended more than a hundred clinical trials throughout India because of the government’s new rules that require those running the trials to compensate any study volunteers who later suffer injury or death – whether the injury or death is directly caused by the study or not.
“This has become very harmful,” said Vivien Tsu, a women’s health expert at PATH who led the HPV study in India. “The HPV controversy and the arguments over clinical trials in India have ended up fueling each other in a way that undermines public health, not to mention India’s role in biomedical research.”
Humanosphere has followed the dispute over the PATH HPV study for a few years now. Many perhaps expected the controversy would subside over time as the evidence accumulated to show it was both beneficial and well-intended. Just the opposite has happened.
There are several controversies running in parallel here. India is one of the world’s leading sites for drug trials, both by international firms as well as the nation’s domestic pharmaceutical industry (the latter which, as a leading supplier of cheap generic drugs, is also often fighting on that front with Big Pharma). Some Indian activists, such as Health Rights Forum, contend the drug industry is exploiting poor Indians as ‘guinea pigs.’
“Clinical trials of NCEs (new chemical entities) are being conducted without following proper protocol, and companies are taking advantage of poor people,” contends Amulya Nidhi, of Health Rights Forum (aka Swasthya Adhikar Manch). The organization cited some 2,500 deaths of volunteers in drug trials done between 2005-2012, which led the Indian Supreme Court to put a hold on planned drug trials and to require the government to report on how it intends to improve regulation.
In turn, the Indian government has issued a parliamentary report that some say has only muddled the issue.
Few seem be paying much attention to the Indian scientific community’s assessment that, of those deaths, only 50-80 deaths could be directly linked to the clinical research studies. Even fewer emphasize that, for many drug trials, the volunteers are already at risk of dying from the disease the study is focused on and that cause-and-effect is not always clear.
Still, there’s no question that Big Pharma and foreign-run clinical research is not too popular in India these days.
The PATH HPV study, Tsu emphasized, was not a routine clinical study in that it was not about testing the safety and efficacy of the vaccine. That had already been fairly well-established in the U.S. and in other wealthy nations that already offer the vaccine to young people.
The PATH study was aimed at tesing the feasibility of adding the HPV vaccine to the standard immunization schedule in two Indian states, Gujarat and Andhra Pradesh. PATH wanted to see if this could be done cost-effectively, without too much disruption or increased burden on the fragile health care ‘system’ of poor communities and in ways that would be acceptable to the community. Some 23,000 young Indian girls were vaccinated before the study was halted.
“India has a huge problem with cervical cancer,” said Tsu. Unlike in rich countries where women are routinely screened for early signs of cervical cancer and treated for it, women in poor communities seldom have access to such services.
Something like 250,000 women – most of them in the developing world – die every year from cervical cancer. More than a quarter of those deaths are in India, where cervical cancer is the leading cancer cause of death for women. (See the bar chart to the right, based on data from WHO’s International Agency for Research on Cancer. )
Had the PATH logistical study been successful and had the HPV vaccine been added to India’s routine immunization regimen, you could logically argue that something like 70,000 cervical cancers in Indian girls were being prevented every year.
Conversely, you could argue that the lack of HPV vaccination – barring the expansion of screening and treatment for cervical cancer – will kill something like 70,000 Indian women.
Who knows? It’s all statistical and based on future deaths, which is hard to get people too excited about. What has the Indian media, politicians and some activists all excited about are the seven Indian girls who died after getting the HPV vaccine in the study as well as the claim that PATH failed to get adequate informed consent.
“Two of the seven deaths were suicides and, in some cases, these deaths came months later,” Tsu said. “The Indian scientific and medical community do not believe any of these deaths were related to the vaccine.”
But just as Katie Couric demonstrated on her TV show imaginatively dubbed ‘Katie,’ one mother’s emotional claim that her daughter died after getting a vaccine tends to trump data and boring reports.
Tsu bridles at the claims by critics that the Indian girls and their families who agreed to participate in the PATH study were not adequately informed. In Gujarat, all consent forms needed to be signed in the presence of a government witness. In the semi-literate and poor tribal communities — where girls and women are at great risk of dying from cervical cancer – Tsu said health workers worked diligently to explain the risks and benefits.
“Imagine the outcry if we had decided to exclude poor tribal girls from this study,” she said.
As one of India’s leading biomedical scientists, Jacob John, recently argued in an op-ed for the Wall Street Journal and in the Indian Journal of Medical Ethics, fear-mongering by the media and politicians can be just abusive and as deadly as an unethical drug company. John was focused on another controversy over a different vaccine, a routine vaccine known as the pentavalent vaccine because it is a five-in-one shot against hepatitis B, diphtheria, pertussis, tetanus and Haemophilus influenza type b (or Hib).
“Why can a country that built its own space and atomic energy programmes not deliver a basic intervention to its children?” wrote John.