As far as testing new drugs are concerned, using the illiterate and poor as guinea pigs is nothing new. But, the recent incident in Piduguralla, Andhra Pradesh, where more than 20 women were subjected to clinical trials for breast cancer by a pharma company has triggered fresh concerns.
According to Agomoni Ganguli Mitra, a PhD scholar at the Institute of Biomedical Ethics, University of Zurich, Switzerland, “Such incidents seem to be especially prevalent in developing countries for two reasons. First, although ethical guidelines exist to protect participants, the mechanisms of protection are fragile and easy to break. Second, the process of developing drugs for multinational corporations is a costly one. So, carrying out part of the research in low-income countries means cutting costs significantly.
In India, for example, WHO says that there are less than 40 fully functioning ethical research committees (ERCs), which approve clinical trials conducted on human subjects. Mitra adds that in countries where inefficiency and corruption prevail, it is difficult to ensure that all the protective measures are being adhered to. That is why a lot of clinical trials take place in countries like India, where much of the infrastructure is cheaper but at the same time there is no dearth of trained personnel.
International guidelines exist, and although the details of these are debatable, many countries have incorporated them in their laws. The problem in India, as in many developing countries, is to ensure that these guidelines or laws are followed. Mitra adds that in the bioethics community, this is a controversial issue — whether offering money is ‘undue influence’ and how much money is too much. On the other extreme, whether participating in research should just be seen as some kind of job that you should be adequately paid for.
“The general feeling is still of discomfort regarding offering money to participants, but this is a reality,” she says.
As far as the global scenario is concerned, most medical institutes in Europe and the US have compulsory ethics courses for medical students. But, Mitra is of the opinion that these courses are at best only a small part of medical education.
The other problem, she says, is that such research tends to involve a multitude of actors, many of whom are not doctors.
“Say, if you have an MBA and work for a big corporation, you are usually taught that your first goal is to make profits for the company. But, then, making profit does not always sit well with larger issues of social or global justice and the consequences can be serious.”