According to an official investigation, it was supervisory shortcomings, rather than problems with a vaccine itself, that led to the death of a baby girl in India last fall during a Wyeth clinical trial.
The infant was sick with a cough and diarrhea and had an underlying heart problem, which meant that she should have been excluded from a clinical trial studying a new version of Prevnar, a vaccine against pneumonia and ear infections. The findings are likely to add to concerns about how well Western pharmaceutical companies oversee human testing of potential new medicines in developing countries.
U.S.-based drugmakers increasingly are conducting trials in other countries., especially developing countries where it is often cheaper and quicker to perform testing with humans. Some 700 clinical trials were conducted in India, China and Russia last year, up from fewer than a total of 50 in 2003.
Critics have complained that patients in poorer countries are being exploited, and serving as guinea pigs to test medicines they may never be able to afford. Some also question whether the trials are conducted safely and correctly.