BIOMEDICAL AND HEALTH EXPERIMENTATION IN SOUTH ASIA: CRITICAL PERSPECTIVES ON COLLABORATION, GOVERNANCE AND COMPETITION

The growth in experimental scientific medical and health activity in South Asia has direct economic benefits and costs, but also has significance for both the practice and theory of 'development'. We have focused on whether such experimental health interventions and clinical trials provide South Asian countries with the opportunity to move 'up the [knowledge] value-chain'; on how they impact on public health programmes; on issues of who controls the global processes of medical and public health research. Our research investigated how far, and under what conditions, knowledge transfers and capacity building takes place in clinical trials and experimental health programmes in India, Sri Lanka and Nepal, and studied the complex mediations between sponsors of the trial or experimental programme and the local agents running the experiments. In joining the international flow of research, doctors, administrators, biomedical and social scientists in South Asia attempt to capture economic, social and cultural benefits of scientific innovation by creating research capacity, relevant training, skills and facilities or generating knowledge of neglected health problems on site, updating patient care systems, and improving overall research cultures. We have studied purpose-created private sector Contract Research Organisations [CROs], universities, NGOs and assemblages of research collaborations that seek to connect international researchers with local institutions, personnel and populations in order to facilitate biomedical and public health research. Wherever possible we 'followed the trial', that is, explored the movement of knowledge, resources and people that make up the assemblages of a particular global experimentation. Civil society activists, university academics, medical professionals and lawyers have mobilised to bring ethical norms to bear upon this experimental activity by improving the mechanisms of regulation and governance: devising registration systems for clinical trials, promoting capacity-building in institutional ethical review and ensuring compliance with international standards. Our research has shed more light on what happens when citizens are inducted and rewarded for their epidemiological characteristics and their 'willingness' to become research subjects. We have mapped these activities and provided ethnographic evidence about the overall situation of such trials, taking a small sample to analyse in more detail how the ambiguities are (or are not) resolved.

The growth in experimental scientific medical and health activity in South Asia has direct economic benefits and costs, but also has significance for both the practice and theory of ‘development’. These activities are a striking example of how knowledge and resources are not based in local settings alone, but are linked in significant ways to similar activities elsewhere in the world. Such linkages have poorly understood consequences for the places in which clinical trials and public health experiments are carried out.
In our research we decided to focus on the impacts of such activity on wider questions of poverty reduction, wealth creation and development across South Asia. We addressed some of the following questions:
• Do such experimental health interventions and clinical trials provide South Asian countries with the opportunity to become experts and control all aspects of trials and experiments, or do they remain at the level just of implementers of the ideas of others?
• How do they impact on public health programmes?
• How are clinical trials and public health experiments regulated, and how might the systems of regulation be improved?
We suggested that such scientific activity can have critical implications for capacity-building, knowledge transfer, commerce and how research activity is generated, conducted, and regulated. Our research was designed to investigate how far, and under what conditions, this takes place.

There are huge expectations regarding the growth of clinical trials in South Asia, and particualrly in India, but the number of clinical trials predicted is not being realised. Having committed to the project of growth, Governments in the regions are struggling to ensure that the ethical and technical infrastructure to support trials is up to international standards, and this is resulting in a variety of tensions concerning governance, resourcing, distribution of benefit which were played out during our research and which are evident from the sample findings below.
1. Institutional Ethics Committees [ECs] are heavily dependent on institutions and sponsors for their very existence. They are mainly ad hoc bodies set up to fulfill a statutory requirement. Independent ECs have emerged as a mirror of the processes of outsourcing and subcontracting, which are an integral part of the clinical research industry. Just as various functions of the research process are outsourced to specialized firms, ethics review has been outsourced to independent ECs to facilitate the clinical trials process.
Overt conflicts of interests in ECs are common, such as directors of institutions or key functionaries of the sponsors sitting on EC. Members are also compromised because they share financial interests or professional or personal relationships with the other stakeholders in the research. However, there are also covert conflicts of interest. When the existence of the EC is itself so dependent on the development of the clinical research industry and their role is so deeply embedded in the logic of market capitalism, there is an intrinsic interest in facilitating commercially funded research, which poses limits to the extent that the EC can exercise its independence.
The particular problem of the ECs in India (and elsewhere in South Asia) may, therefore, not be resolved by measures currently being considered in the region. It is necessary to create a structural framework that protects the independence of the ECs and enables them to function in accordance to the existing or envisaged guidelines. A rationalization of the numbers of ECs, laws and rules that regulate EC 'shopping', an independent funding mechanism and an effective mechanism for audit are required. These cannot be achieved without replacing the current market-based logic of development of ECs with one that stems from public interest. The objective of the ECs must not be to promote research, but to promote ethics. This goal cannot be achieved without the state assuming the central role in the process.
2. In clinical trials, the research capacity of the Principal Investigators [PIs] remains very limited. Although PIs acquire and (some) hope to utilise skills in their own research, these skills are usually limited to good protocol adherence and data collection. The most important elements of a research project, such as protocol writing, sample selection and statistical analysis of data are all done elsewhere. Hence, in reality, the PIs are mostly acting as data collectors and the data are immediately handed over to the sponsoring drug company. PIs have no authorship or publication rights.
Accountability in these trials is distributed and hidden. As the trial is structured with many compartments and players coming in only for a particular role without engaging with the trial completely, tracing one individual or entity for an error or harm is difficult. While data safety and monitoring boards exist, and ECs mandate that all Severe Adverse Events (SAE s) should be reported, the practical reality of this is very complicated. The PI delegates tasks to an array of staff, such as Co investigators, Clinical Research Co-ordinators, and Clinical Research Assistants. Also, monitors from the CRO visit the site regularly. Most of the paper work and coordination, including interacting with patients and ethics committees, is carried out by young life science graduates. They have not had standardized training courses, and they turn over regularly. In these circumstances, many of the ethical issues are handled poorly or not at all.
3. In public health interventions, the biomedical RCT model for evidence generation has become dominant. The understanding of public health ethics is very problematic, as most field workers who collect data have no formal training and learn 'on the job'. Most experiments are usually some interventions which are useful services, as opposed to limited or no services at all. Hence the concept of free, voluntary informed consent is complicated, as are issues of post-trial benefits. The interventions we studied aimed to be scaled up and become public policy. Our study suggests that such up-scaling often bears only a very limited relationship to the findings of the intervention, since the up-scaling takes place before the study has been completed, or policy changes much more extensively than the study results warrant.