Scientists to begin evaluating human infection studies in India

A major reason scientists globally are pushing for human infection models is that animal models to study infectious diseases have been failing
Some medical scientists in India are actively discussing whether the country should begin human infe­ction studies, in which weak, disease-causing microorganisms or pathogens are deliberately intro­duced in healthy people to study how those pathogens transmit dise­ases, how the diseases progress, how people’s bodies respond to the dise­ases, and how effective certain treatments are against those dise­ases. India currently does not have regulations to carry out such studies.

Scientists 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 still remain to be tackled, especially around ensuring that poor and vulnerable people are not exploited. This has happened in the 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 past 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 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 might 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 poorer countries, inclu­ding Kenya, Mali, Gabon and Thailand.

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.”

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel