Should India begin human infection studies?

Some medical scientists in India are actively discussing whether the country should begin human infection studies, in which weak disease-causing micro-organisms or pathogens are deliberately introduced in healthy people.

This is done to study how the pathogens transmit diseases, how the diseases progress, how people’s bodies respond to diseases, and how effective certain treatments are against those diseases.

India does not have regulations to carry out such studies.

Scientists had met lawyers, sociologists, anthropologists, ethicists and journalists in a big consultation in Mumbai last year to discuss issues around human infection studies in India.

While some scientists agree that such studies will benefit Indians, thorny issues persist, especially around ensuring that poor and vulnerable people are not exploited, which has happened in case of clinical trials in India.

The discussions led to a series of articles in the current issue of the Indian Journal of Medical Ethics or IJME. Human infection studies have mostly taken place in developed countries where there is infrastructure to monitor research participants, and track results.

But in the last couple of years, the conversation is building up to increase the capacity of developing countries to do these studies because certain infectious diseases are more common there.

It makes more sense to study those diseases in local participants because they could respond to infections differently, given that some of them are already exposed to the pathogens, than the participants in developed countries, says Gagandeep Kang, executive director of Translational Health Science and Technology Institute in Faridabad.

So, the vaccines or drugs developed by testing on white people may not work well on people who are more likely to need them. About 143 human infection studies have taken place in developed countries, and only 12 in poor countries, including Kenya, Mali, Gabon and Thailand.

Conducting such studies in India are an ethical obligation, argues Saumil Dholakia, psychiatry professor at the Christian Medical College in Vellore, in his article in IJME. We need to do justice to our own people by generating molecules and testing them in our own population for its benefit at the same time making sure that the participants are ethically protected, says Dholakia. He gives the example of the recent typhoid vaccine developed by Hyderabadbased biotech company Bharat Biotech, which did the human infection study on participants in Oxford although the virus strain was developed in India. It would have been better to conduct the study in the Indian population because typhoid is common here, says Krishna Ella, managing director of Bharat Biotech.

One major reason scientists are pushing for human infection models globally is because animal models to study infectious diseases are failing. Scientists say the interaction between the human and the pathogen is very specific in case of some diseases. “Humans get dengue,” says Kang. “Dogs don’t get dengue. Rabbits don’t get dengue.” Infectious diseases contribute to 27 per cent of deaths in India. Scientists say human infection studies could also make the drug or vaccine discovery process efficient by predicting failure faster. For example, if you have 10 trial vaccines, you could give it to a small number of participants and then infect them with a pathogen to check which vaccine worked and which didn’t. In conventional trials, scientists would give those 10 vaccines to a large number of participants and then wait for them to get infected naturally.

Laying the ground for such studies would require resources to set up high-quality research infrastructure to generate pathogen strains.

Some scientists argue that the first step should be to collect national level data about the genetic and immunological profile of the population.

Even if human infection studies are valuable, say scientists and ethicists, the tests should be allowed only after they ensure that poor and vulnerable populations are not exploited. Ethical concerns emerge from the space where India has a whole history of violations of the informed consent process and oversight of ethics committees in some clinical trials, says Anant Bhan, an independent bioethics researcher in India.

The issue of compensation for lost time, income and transport cost to participants, for example, is a tricky one, especially in developing countries where money could influence poor people to participate in human infection studies, says Amar Jesani, one of the founders of IJME. “We are keenly watching these discussions,” says an official of the Indian Council of Medical Research or ICMR, a government institute responsible for coordinating biomedical research in India. “It (human infection studies) is a very new thing for India, and needs more discussion. If scientists justify the need, we’d be happy to work on this.”