Conducting such studies in India is 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 Hyderabad-based biotech company Bharat Biotech International, 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 globally are pushing for human infection models 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 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, including labs to generate pathogen strains, and facilities to isolate participants to prevent them from infecting others in their community. Some scientists argue the first step should be to collect national-level data about the genetic and immunological profile of Indian population to better understand results in human infection studies.
Even if human infection studies are valuable, say scientists and ethicists, they should be allowed only after it can be ensured that poor and vulnerable populations are not exploited. The ethical concerns emerge from the space where India has a whole history of violations of informed consent process and oversight of ethics committees in some clinical trials in India, says Anant Bhan, 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.
Although ethicists say participation in such studies should be voluntary and not induced by money, studies have shown that any payment could be an inducement in poor countries.
Ethicists suggest that one way to ensure voluntary participation is that medical researchers go out in communities to educate them again and again so that people fully understand the research and risks before consenting to participate.
What also needs discussion is whether and how the profits earned after discovery of a vaccine or drug will be shared with those who participated in human-infection studies, “otherwise it is an unequal relationship,” says Jesani.
“We are keenly watching these discussions,” says an official of the Indian Council of Medical Research, a government institute responsible for undertaking and 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.”