Monday 08 February 2010

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Health Report 28 min 1 speaker 8 chapters transcribed 3 days ago

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Transcript generated automatically by AI and may contain errors.

Why are pharmaceutical companies shifting clinical trials to India?

Norman Swann 0:00

Hello, it's Norman Swan here with a health report. Welcome. In this program, a major issue that's barely mentioned in Australia. It's the fact that drug companies are carrying out more and more of their medications trials in developing and emerging nations. And these are drugs which will be used one day in Australia. And one of the leading countries doing this is India. It's a lot cheaper for the pharmaceutical industry and the quality of the research can be high. But a leading Indian ethicist claims that another reason is that it's much easier for drug companies to obtain ethics approval for a trial because, he says, Indian ethics committees are weak, poorly trained and tend to be rubber stamps. The results could be shortcuts, exploitation of participants and perhaps even questionable findings.

Norman Swann 0:43

Ethics committees have to approve a trial to protect the participants. Dr. Amar Jasani is the founder of the Center for Studies in Ethics and Rights in Mumbai, possibly the only institute in India devoted to the study of bioethics.

Amar Jasani 0:57

There were two major developments that led to the increasing in clinical trials. One was relaxation in the Patent Act. India had a Patent Act of 1970, which only provided patent for the processor, not for the product. So pharmaceutical companies didn't want to come to India because they didn't have intellectual rights protection for their drugs. Absolutely. The government carried out the final modification in the laws. The second was in 2005, the government of India made a massive change in the clinical trial-related laws.

Norman Swann 1:31

Previously, this law had limited the trials permitted in India, and the Act's liberalisation freed things up and put India more on a par with what's allowed in countries like Australia. Raju Chako is a medical oncologist, a cancer specialist, at the Christian Medical College in Valore, southern India, one of India's best medical centres. Raju is heavily involved in clinical trials into cancer drugs, and there's one big reason why from his point of view.

Raju Chako 1:57

As a medical oncologist, I come into contact with many patients with solid tumors, and my interest has been developing new drugs for the unmet needs of these patients.

Norman Swann 2:12

And when you say solid tumors, you're meaning really tumors that turn into lumps rather than, say, blood cancers like leukemia or lymphoma, that sort of thing.

Raju Chako 2:21

That's correct, yes. And in a country like India, where you have so many patients who need cheap answers to their problems, you need answers that they can afford. One of the things that I've been trying to do is look at the local pharmaceutical industry and try and support the research that they do. so that the kind of molecules that come out in this country would be answers to problems of this country. Of course, I do research for multinational companies and would sell their drugs out in the international market and expensive for India in comparison.

Norman Swann 2:56

So give me a picture. You've worked in Adelaide, you trained in Adelaide, so you know what it's like. Give me a sense of what happens to the person in the street in Valore, in Tamil Nadu, with cancer compared to a rich country like Australia.

Raju Chako 3:09

This particular person who's on the street and below would have difficulty accessing me because there's so many people who tell him that it'd be too expensive to come to me.

Norman Swann 3:18

But there's no public care effectively?

Raju Chako 3:20

Yes, there is some public care, but even then, what he can access in the public care may not be standard of care. When he does get to me, the main issues would be, can he afford the care? Cancers

Norman Swann 3:33

are diagnosed late.

Raju Chako 3:35

Most cancers are diagnosed late, yes. In this hospital, we try and provide therapy to patients who may be potentially cured, even if they can't afford it. But that's not the case everywhere. And if you come to us for treatment that is going to be palliative, we couldn't afford to treat you unless you paid for it. So you make a

Norman Swann 3:58

decision up front for people who can't afford it. If it's curable, you'll treat. If not, you make that tough decision.