Attention for unethical testing practices

On International Clinical Trials’ Day a coalition of five European organizations led by the Wemos Foundation draws attention to the situation of human subjects taking part in clinical drug trials in developing countries.

Clinical trials of new drugs are increasingly being conducted in developing countries. In most cases, the drugs concerned are intended for the Western market. Reports published by Wemos and the Centre for Research on Multinational Corporations (SOMO) reveal that some pharmaceutical companies fail to observe the established codes and guidelines for medical research involving human subjects. A case in point is the Trovan incident, in which Nigerian authorities accused Pfizer of testing a new broad spectrum antibiotic on children with meningitis, without first obtaining their parents’ consent.

Sandhya Srinivasan, executive editor of The Indian Journal of Medical Ethics, is an acknowledged authority on the subject of clinical trials. She is visiting the Netherlands to talk about the risks of drugs testing in developing countries and will join Wemos in discussing ways in which the position of vulnerable test subjects can be improved. Srinivasan states, "I am concerned about the growing importance of India as a centre for cheap clinical trials run by foreign pharmaceutical companies. Their main objective is to gather the data required to obtain marketing authorization in Western countries. To do so, they exploit the poor of India."

"The problem is that the country lacks the infrastructure and manpower required to enforce legislation, technical standards and ethical guidelines. Although the commercial research organizations are striving to develop the required expertise, the government monitoring system is acknowledged to be woefully inadequate. There are implications not only for the Indian people but also for those who actually use the drugs in Europe and elsewhere. At present, the quality of clinical testing in countries such as India cannot be adequately guaranteed."

The lack of proper supervision in the developing countries in which the clinical trials are actually held renders stringent control essential at the European level. The coalition led by Wemos is therefore calling for more manpower and resources to be made available to the European registration authorities. The partners – Wemos, SOMO, Farmacie Mondiaal, Health Action International Europe and the European Medical Students’ Association – are to communicate their concerns and demands to the ministers responsible, Mr Klink and Mr Koenders.