Anyone interested in the ethics of clinical trials in developing countries should look at this five minute video of an interview with Amar Jesani, a leading human rights advocate in India.
Dr. Jesani, who I had the privilege of meeting with at the Center for Studies in Ethics and Rights in Mumbai during my recent trip to India, reports the prediction that in ten years one third of all clinical trials will be done in India. The primary reason is cost reduction - trials are 50% - 75% cheaper to do in India than in the U.S. And India's huge population means that there are enough patients with the condition being studied to conduct most trials.
According to Jesani it is easier to carry out trials in India because although there are laws that ostensibly protect patients, regulation is very lax. Poor patients are desperate for care and are typically subservient to their physicians. Government inspection and ethics committee oversight is week, and the regulatory process is subject to corruption. The picture he sketches is not pretty.
Jesani explains that he and his colleagues are fighting for three things. First, clinical trials done in developing countries should be relevant to their needs. Second, in the course of the trials there should be no human rights violations. Finally, if the trial is successful the drug should be available in the developing country at an affordable price.
The video is thoughtful and constructive. The comments it received are not. Here's the most printable one: "I have been conducting clinical trials around the world for 18 years. This video is a scam this doctor is a liar...This guy is probably trying to scam a few million from the drug companies in an extortion con."
In the last few years in the U.S. we've seen a rising crescendo of criticism of the ways the pharmaceutical industry has corrupted science and clinical judgment. The ethics of international drug trials will come next in this advocacy process. If the issues are new to you, have a look at the video.