Tuesday, February 10, 2009

Drug Trials in India - a Video Interview with Amar Jesani

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.


Dakshina T Maratt said...

Hi this Dakshina from Times Now Television India. I am doing an extensive report on clinical trials in India. Trying desperately to get in touch with people who have gone through their trials so that they can tell thier stories. If you anybody or any organization that can help me in this matter. It will be great.
mob no: 09710936129

Jim Sabin said...

Hi Dakshina -

I don't know individuals who you could talk with, but the story you're working on is important. Let us know what you find!



Unknown said...

hi this is aarthi i am a pharmacist. As far as i know that the cilinical trials in india are confined to very strict regulations laid down by our govt. We cannot test any new product of other country to our people unless they have done it in their own country with their people. Media people should understand that the maximum no of trials are done in developed nations. If we dont want our people to be alliens to new drugs we should make the oppuortunity to develop our health care system. Any professional who is not willing to upgrade their knowledge is not appropriate.

Jim Sabin said...

Hello Aarthi -

Thank you for your comment. I'm sorry for the delay in responding.

I hope you are right in your view that clinical trials in India are strictly regulated. Certainly Amar Jesani and others see the situation very differently. But I agree with you on the importance of upgrading the health system, and especially with your view that being willing to upgrade our knowledge is a central aspect of being professional.