Sunil Shaunak on ethical medicine, patent laws

Sunil Shaunak of Imperial College, London, is pioneering 'ethical pharmaceuticals'. He talks to Subhra Priyadarshini about his work, evergreening and the probable threat of the patent legislation they could face from big pharmaceutical companies

Published: Monday 30 April 2007

Down to EarthWhat exactly do you mean by ethical pharmaceuticals?
This idea was triggered when Steve Brocchini (a colleague and a research chemist at the London School of Pharmacy) and I started taking the aids epidemic seriously. Many people were dying due to lack of access to drugs. We wanted to take another look at how to make medicines affordable for the poor.

So we set out not only to be inventive and creative but also to do good research to slash costs. We wanted to make provision for medicines for patients in clinics. The idea was to make sure that the cost of drugs did not come in the way of proper treatment.Big pharmaceutical companies have created drugs for the rich and the poor are forced to buy them for lack of an option. We wanted to reverse this trend. This is what we call ethical pharmaceuticals.

How do you intend to make new and affordable drugs?
We are researching interferon, a protein that occurs in the human body. If you make enough of this protein in the body, you can cure yourself of Hepatitis-c, which kills 170 million people worldwide every year.

Three years ago, we found that if we took interferon and put a big sugar molecule on its outside, it becomes a fantastic medicine. And combined with an antibiotic called ribovirin, it can cure Hepatitis-c.

The problem now is that the cost of treating a patient with the only available Hepatitic-c medicine is around us $13,748. By doing the interferon-sugar trick, we were able to produce the same drug at very low costs and the cost of treatment came down by 90 per cent.

How is this different from 'evergreening', which multinational companies use to keep their patents alive?
We are not getting into the bandwagon of generic drugs. The novelty here is that it is an incremental advance in creating second and third generation drugs.

As opposed to generics, which don't make any basic improvement in the structure of the medicines, these are different at the molecular level.

What motivated you to get into this kind of research?
As a young doctor, I was moved by the plight of aids patients. I shifted from London to the us since I was an infectious diseases doctor. hiv was the territory of genito-urinary doctors in the uk. The us was an eye-opener. There was such a massive divide between the rich and poor. Patients without money had nowhere to turn to for the expensive treatment.

When an affluent patient died, we requested the family to return unused hiv drugs so that a poor person could use it. This is what led me to work in making healthcare affordable.

Besides, while working in Africa, I had this amazing experience that fuelled this ambition. A little boy came to me with a can of Coca-Cola. I really can't understand the logistics of why we can't take medicines to remote areas if these multinational companies can reach there. All we need is locally trained healthcare workers.

When will your drugs be tried in India? And when do you expect them to be launched in the market?
Hyderabad-based Shantha Biotech will manufacture the first drug for Hepatitis-c after clinical trials supported by the British government in India later this year. The project is being supported by the Wellcome Trust, the British government's Department for Trade and Industry as well as the Foreign and Commonwealth Office. Then we will get into fast-track trials for a cheap drug for leishmaniasis or kala-azar in Bihar. For this, we are collaborating with Medecins Sans Frontieres. Technically, these are new drugs and will have to undergo the usual trial and licensing process. The trials for the first hepatitis-c drug will be cheaper because manufacturing in India is cheap.

This project is backed by grants from philanthropic bodies in the uk.

How do you think big pharmaceutical companies, which stand to lose a lot of business with your innovation, will react to this?
We know they will try every trick in the book to remain in the business. The pharmaceutical companies will try to get around this by taking a fresh look at patent protection. Our patent attorneys are convinced this is original work. And the biotechnology industry is investing a lot of money in our work. Obviously, their patent attorneys are also working overtime. I am sure they will devise ways to work past us. But it will be difficult to beat out novelty.

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