'The People's Health at the Center, not the Profit'
Amar Jesani is a medical doctor from India with expertise in medical ethics and human rights. In September 2008, Wemos interviewed Dr Jesani and posted the interview on YouTube. The current article is based on this interview and includes some of the questions that were not incorporated in the online interview.
Dr Jesani, will you please introduce yourself?
‘I come from Bombay and I studied medicine in the seventies. Since then, I have been doing research in public health. Since the late eighties, I have been associated with work on medical ethics. We have looked at the ethics in clinical practice and research, particularly in biomedical research and clinical trials. Now, I'm doing a lot of work in ethics and public health.
‘I have been associated with non-governmental organizations. The Centre for Studies in Ethics and Rights is one working on bioethics. And we've been publishing the Indian Journal of Medical Ethics for the last 15 years.’
Why are pharmaceutical companies increasingly shifting their clinical drugs trials to developing countries?
‘They are doing it because it is cheap. We find that a cost reduction of almost 50 to 75 percent can be carried out if they do it through companies in developing countries. Another reason is that India is a very big country. So pharmaceutical companies are able to find enough patients for their trials. The third reason is that compared to many of the developed countries, in our country there is no universal access to health care services. Eighty percent of health care is delivered through the private sector and a large number of people who have diseases are not able to get any. So companies claim they get patients who are treatment naïve and who can be directly treated by the experimental drug. You do not have to worry about the washing out of other drugs they were taking.’
Why is India a popular location for clinical trials?
‘There are laws in my country, but they are not very well implemented. The regulation over the trials,
the oversight mechanisms, the functioning of the ethics committees and the regulatory body, the Drug Controller General of India, are so lax that it makes India a big destination for clinical trials. In the next ten years, one third of all the clinical trials in the world will be carried out in India. This is a very alarming situation where Indian people will be used for experiments.’
What people participate in clinical trials in India?
‘Most of them are from poor, vulnerable strata without resources. Many are illiterate, they can't even sign their name. Apart from that, they are very desperate people. They have either terminal diseases or they have no way of getting good health care in India. So the most vulnerable people of society are being used for the trials. That bothers me the most.’
Some say that participating in clinical trials is better than having no access to drugs at all. What do you think?
‘Out of the hundreds of thousands suffering from a particuler disease, your trial participants may run into a few hundred, at the most. So you are providing benefit to only a few. The real benefit for the hundreds of thousands who are suffering from that disease will come only after the drug is found to be good enough and is made available to the entire community of that patient. But that doesn’t happen because of intellectual property rights. The costs are kept to such a high extent that these people don’t get the drug.’
How do ethical review committees in India function?
‘The ethics committees are coming up, but they have problems of competence, independence and good financial support. If you decentralize the work of ethics oversight, then we need more vigilance, because thousands of committees are involved. That vigilance is not present at the moment. We also have to do a lot of capacity building. That is another requirement which is not just the responsibility of the Indian government but also of the international community and of the regulatory agencies of Europe and the United States, because they are all connected in some way. The trials come from the developed countries where pharmaceutical companies are located and where these regulatory authorities have certain power.’
Can you give an example from your own experience as a member of ethical review committees?
‘I have stepped down from ethics commitees where I felt very uncomfortable. Uncomfortable in the sense that when I raised critical issues about the trial, people were not ready to look at them in an objective manner. Or I saw that too many trials were being conducted without providing enough time for quality review. Or I found that the investigators, the senior doctors, were involved in too many trials. A doctor being involved in 35, 40 trials at the same time. It alarmed me. I have been doing research but I don’t remember working on more than a couple of big research projects at the same time. How can these doctors who can do 35, 40 different drugs trials at the same time, and be good at all of them?’
Why are the authorities in India unable to control the situation?
‘Well, I think the rot starts from above. That is the Drug Controller General of India’s office, which is the legal regulator. They don't have good scientists, they don't have enough inspectors to go all over the country – and India is of continental size, as you know. And the third is, which is the worst thing in every developing country, is the corruption. There is too much corruption. No one is sure if the inspector will be there. And if he does come, will he be a really independent person? Because they do take bribes and come under the influence of pharmaceutical companies. In fact, it is well know in India that the Drug Controller General's Office is one of the most corrupt offices. So corruption is a major problem.’
Some say that ethics cannot be transplanted from one culture to another. Trials that are not acceptable in richer nations, may be acceptable elsewhere.
‘Principles and standards of ethics are universal. But the way you implement them in different contexts requires that you operationalize them differently. For instance, you have a standard saying that a person who participates in a trial is an autonomous person and that person’s wishes should be respected. Now, if you go to the Asian countries, you will find that they have a very strong family or community based system, where decisions are often taken by the head of the household or by a man. What happens to a woman when she has to decide whether to participate in a clinical trial or not? She would tend to tell you: “My husband or my father will decide.” As a part of our commitment to human rights, we may advise her to take consultation of anybody she likes, her father or her husband. But we have a duty to ensure that the final decision is hers. When it is being taken, we must sit with her separately and find out whether she would really like to participate or not. So yes, there are different kinds of family and cultural systems. In that kind, operationalization becomes slightly different than in the developed countries.’
What do clinical trials on people in developing countries have to do with European citizens?
‘A lot, isn't it? If trials are done in an unethical manner, in violation of human rights, Europeans would be guilty of making use of such drugs which have violated human rights. So it's very important for Europe and all the developed countries to ensure that during the trial no human rights violation has taken place. That'll also ensure that the science, the quality of the trial is as high as possible and there is no cutting off corners in the quality in order to make it cheaper. So in both ways, it's very important for Europe to ensure the trials are done in an ethical manner.’
What are you fighting for?
‘We are fighting for three things, to put it very briefly. Clinical trials in developing countries should be relevant to their needs. The second is that in the course of trials, no human rights violation should take place. And the third is that if the trial is successful, the drug which is developed should be available in developing countries at an affordable price.’
How do you see the future?
‘The struggle is long. We may not win in my lifetime. We have been talking about ethics and human rights for more than 15 years now. But we have not made a big dent in the situation as yet. So it takes time. It takes time to convince people. Sometimes people are too enamoured by science and scientists. In India, some people still believe that doctors are god. When doctors want to take informed consent, many people will say: “Doctor, you decide what is best for me.” So people have that kind of faith in scientists and doctors. It takes time to tell them that there could be something wrong in science too. It's best for them to decide themselves by understanding what's right or wrong, rather than having blind faith in anything or anybody. That is the only way for the nation to develop’.
‘Science is there, you know. Clinical trials may be required in order to combat new diseases as well as getting new ways of combating old diseases. So we can't stop clinical trials. The private companies will stay around. They are going to make it a business. The best way is to regulate it properly. Ensure they don't compromise science and ethics in the pursuit of the profit. The people's health should always remain at the center, not the profit. That is the minimum thing we can fight for.’