|The new drug for kala azar will revolutionise treatment protocols in Bihar, which is much affected by the disease
With a dash of molecular wizardry, a British physician of Indian origin is giving the world its most effective solution ever to soaring healthcare costs. In what is being heralded as a wonderful gift, particularly for developing nations, Sunil Shaunak, a professor of infectious diseases at the Imperial College in London, is making minor changes in the molecular structure of existing expensive drugs marketed by multinational pharmaceutical companies and turning them into cheap, new drugs. Old wine in new bottle' Kind of, but a lot more affordable. So just how does Shaunak do this' Shaunak, who’s also a consultant physician at London’s Hammersmith and Chelsea and Westminster Hospitals, and his colleague, Prof. Steve Brocchini, a research chemist at the London School of Pharmacy, have found out a revolutionary new model they call “ethical pharmaceuticals.” They look at expensive drugs whose 20-year patent has expired and improve the structure of their molecules to manufacture them at a fraction of the cost that the multinationals charge.
“It’s nothing amazingly different. In clinical academics, all of us have been working with molecules all our lives for big drug companies. The only difference is now we realise that with a little spin, all this can be done cost effectively,” Shaunak says.
Shaunak and Brocchini modify the drug molecules by attaching substances called polyethylene glycol (PEG) polymers to the relatively small immune proteins, making them large enough to withstand rapid metabolism and excretion. The process, known as pegylation, has proven to be a money spinner for the pharmaceutical giants, which charge high prices for their products. The two doctors have developed a new method of pegylation that does not infringe upon existing patents. The new molecule was reported in Nature last June and was found to be as effective as the existing product. The team has successfully applied this approach to pegylation of various body molecule types like cytokines, enzymes, antibody fragments and peptides, without destroying their tertiary structure or abolishing their biological activity.
So is it simply a case of a-little-twist-here and a-little-turn-there' “No, we are not trying to do copycat medicine. Nor are we into generic medicine manufacture,” says Shaunak. “It is not piracy because we are not side-stepping any patent. These are new medicines. The idea is to turn the marketing model upside down - make medicines for poor people which eventually can be used by the rich rather than making medicines for the rich and forcing the poor to buy them.”
Shaunak says big pharmaceuticals patent the fact that one cannot put a sugar molecule on the outside of the drugs. However, they have done just that — put cost-effective sugar molecules on the outside, thus drastically bringing down the price of the drug.
“Think of the disease like a room with three doors,” Shaunak explains. “The first door was opened by big pharmaceutical companies. We have found the second door. And some clever doctor will some day find the third door. There are 150 million people who could benefit from such drugs. So it makes sense that we keep thinking.”
On their first ground-breaking project, the duo is working in collaboration with the Hyderabad-based biotech company, Shantha Biotechnics Ltd, and is poised to manufacture the first such drug — for hepatitis C — soon, if clinical trials supported by the UK government are successful. 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.
Coming up next is a cheap drug for leishmaniasis or kala azar. The project began in London in the first week of January this year. Shantha will begin clinical trials in Bihar very soon. “Bihar has the maximum number of kala azar cases and we hope the new drug will completely revolutionise treatment protocols in many more poor countries,” says Shaunak. For the kala azar project, the doctors are collaborating with international humanitarian aid organisation Medecins Sans Frontieres.
So what after kala azar' Shaunak is wary of disclosing the details as yet. “I think we can concentrate on bottling these two drugs first and then getting into newer areas later. But yes, we have a whole lot to do.”
Shantha was an obvious choice for the Indian experiments. “They had shown missionary zeal when they manufactured the world’s first cheap Hepatitis B vaccine. They were feted by the Indian government for practising altruistic medicine. They were already making original interferon, the key molecule for cheap drugs. And they readily came forward to support the main objective of our mission — drugs for the ailing poor,” Shaunak says.
The Indian government has also agreed to subsidise the clinical trials to take place before drug licensing.
The team’s efforts mean all these costly drugs will be around 90 per cent cheaper than those produced by their big pharmaceutical counterparts.
This means that an annual course of the Hepatitis-C antiviral treatment (a combination therapy of interferon alfa and ribavirin) will cost around Rs 4,000 instead of an approximate Rs 40,000.
“Why should we be completely dependent on the big pharmaceuticals when we make all these drugs in the universities' They have long made us believe we have no option. But now there is. American universities have sold so many patents to pharmaceutical companies and they have been buried because there’s a lot of competition. What’s the use of invention if it is to be buried,” Shaunak asks.
For all their inventions, Imperial College will hold the patent to prevent anybody attempting to block a drug’s development. Once the drugs have passed through clinical trials and been licensed in India, the same data could be used to obtain a European licence so that they could be sold to bodies such as the UK’s National Health Services, ailing under the impact of massive drug costs.
Explaining their position of ethical pharmaceuticals, Shaunak says, “Academics have a choice. They can use their ideas and creativity to make large sums of money for small numbers of people, or they can look outwards to the global community and make affordable treatments for common diseases. Cash, certainly, is not the objective here.”
Shaunak, whose family came from Punjab to London in 1967, says he was moved by the plight of AIDS patients as a young doctor. He had to shift to the US since he was an “infectious diseases doctor and HIV was the territory of genito-urinary doctors in the UK.”
“It 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. So when an affluent patient died, we requested the family to return unused HIV drugs so that a poor guy could use them,” says Shaunak.
What are ethical pharmaceuticals'
Doctors with a motive to serve the poor are modifying expensive medicines and making new drugs out of them to suit the hot climates of developing countries. These novel medicines, ethically made, no longer remain under patent protection.
Are they different from cheap generic medicines'
Yes. Generics are carbon copies made at lower cost. These drugs have a spin in their molecules to make them structurally different but with the same effect on diseases.
Do they breach any laws'
Indian patent laws allowed the manufacture of generics until 2006. The laws have changed and one can’t make generics in the country anymore. World trade rules permit their sale to poor countries, though. However, there are no affordable drugs for many debilitating and widespread diseases.
What about costs'
Technically, these are new drugs and will have to undergo the usual process of trials and licensing. The trials of the first drug, for hepatitis C, will be cheaper since the Indian government will partially fund it. Manufacture in India is also cheap. Moreover, it is backed by grants from philanthropic bodies in the UK.