Friday, February 02, 2007

Outsourcing death?

While reading the following article on how a trial on an anti-HIV gel was stopped (Trial On Anti-HIV Gel For Women Stopped) because the group of women using the active gel were being infected with HIV at a higher rate than the placebo group. I noted the following paragraph:
"The trial was being conducted on over 1,300 women in Benin, India, South Africa and Uganda. Another trial in Nigeria, sponsored by Family Health International, using the same product has also been stopped as a precautionary measure, although there is no news as to whether this trial was giving similar results."

I am intrigued to know how the choices of the selected women were done and the ethics behind the decision to use control groups in Africa and India to test North American created products. Have we outsourced our riskier clinical trials to poorer nations with weaker laws and controls to avoid the costs of having to do the tests in North America and the long term follow-up issues in case of product failure? What consent mechanisms are in place? Are the participants fully aware of the implications of their choice to be part of the trials?

This approach of farming out product testing does not look right at first read. If anyone has further information on this, please send it to my e-mail. Thank you.