Drug companies must do more for poor countries, conference is toldBMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7416.642-c (Published 18 September 2003) Cite this as: BMJ 2003;327:642
Drugs companies need to think very carefully about trials carried out in the developing world, a leading expert on molecular medicine has warned a conference on the drug industry's future. And the industry should do more to address the need for medicines in the developing world, said another speaker.
David Weatherall, emeritus professor of medicine and former director of the Weatherall Institute of Molecular Medicine, Oxford University, was addressing a two day international conference on the future of the drug industry and its search for new medicines, held in London last week by the Royal Institute of International Affairs.
Research in developing countries could raise issues that may not be so high on the agenda in the developed world, he said, explaining that he had recently returned from a project in Asia which was carrying out genetic testing.
“One woman said to me, 'We've got a lot of arranged marriages. If I find out I am a carrier for a genetic disease I will never get a husband in this society.' And a lot of testing will be in developing countries, few of which have broad regulatory structure,” he said.
Meanwhile Dr Mary Moran, medical adviser for Médecins Sans Frontières's access campaign, pointed out that only 1% of new drugs developed between 1975 and 1995 were for the developing world.
Moreover, the way in which the patent system works means that many so called new drugs are not innovative at all. Of the 1035 new drugs approved by the Food and Drug Administration between 1989 and 2000 only 23% showed therapeutic benefit, she said. She added that “76% were no better than the existing drug and two thirds had the same active ingredient as existing drugs. We are incentivising the industry [through the patenting system] to produce more of these.”
As an alternative model she gave the example of Australia, which will only pay extra for drugs that are genuinely new. “It is just basic common sense,” she said. Australia only pays two thirds of what the United Kingdom pays for the less innovative drug compounds.
She outlined an initiative to fund research into diseases prevalent in the developing world. The initiative, which was being championed by Médecins Sans Frontières, aims to make six to eight drugs for a range of neglected diseases available over the next decade (5 July, p 11).
All too often drugs that were not viable commercially in the developing world were withdrawn from the market. The FDA approved eflornithine hydrochloride in 1991 for sleeping sickness. But the market was so small that the manufacturer withdrew it. The drug then proved to be successful, in a cream format, for restricting the growth of facial hair. Only then was it produced in sufficient quantities for the manufacturer to start producing it in an injectable form for sleeping sickness as well.
Dr Mervyn Turner, senior vice president for worldwide licensing and external research at Merck Research Laboratories, echoed comments made earlier by Professor Weatherall that advances in pharmacogenetics were likely to move much more slowly than had first been predicted.
He also outlined several theories for why the productivity of the drug industry was in decline. These included the fact that disease had become more complex, safety standards were much higher, and companies had merged.
“Maybe the big pharma model does not work anymore,” he suggested.
But despite all the potential advances on the horizon, the biggest challenge was understanding why, after all the years of investment, drugs fail, he said.
Meanwhile Peter Cardy, chief executive of Macmillan Cancer Relief, called for patients' views to be taken into account more when drugs are developed.
“In taking decisions to develop new drugs, to what extent does research and industry take into account the interests and priorities of the patients and carers who will ultimately be the users of those products? Nothing like as much, I suggest, as they consider the clinical outcomes and the market position of the products,” he said.