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No new R&D on drugs for diseases affecting poor, says new report

by Kanaga Raja

Geneva, 9 Oct 2001 - A new report by the international medical aid NGO, Medicins Sans Frontiers (MSF), says that there are now virtually no new drugs being researched and developed for fatal diseases that mainly affect the poor.

One of the claims being promoted at the WTO, in relation to TRIPS, is that such intellectual property protection is necessary for innovation and availability of drugs to combat diseases.

The report, titled “Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases”, surveyed the R&D activities in drugs of 20 top-grossing pharmaceutical companies in the world.

The report detailed the responses of 11 of these companies, which together account for combined sales of nearly $117 billion.

MSF says that from these 11 companies, only one new tuberculosis drug emerged on the market in the last five years.

Of these 11 companies, eight reported no research activities in the past year for fatal diseases that predominantly affect the poor, namely sleeping sickness, Chagas disease and leishmaniasis.

MSF points out that people in developing countries, who make up about 80% of the population, only represent about 20% of worldwide medicine sales. It adds that one of the aims of the report was to highlight the stark reality of the lack of research and development R&D) into drugs to treat the diseases of the poor.

Sleeping sickness, for example, afflicts up to 500,000 people and threatens another 60 million in Africa.

For Chagas disease, which threatens a quarter of the population of Latin America, only children can be treated because no effective drugs exist for adults, MSF adds.

MSF reiterates that this lack of R&D for diseases common in developing countries means that very few new drugs have been brought to market for them.

“Millions of people in developing countries are dying every year because the only drugs available to treat many infectious diseases are old, toxic or ineffective,” says Dr Bernard Pecoul, Director of MSF’s Campaign for Access to Essential Medicines.

“Tropical diseases alone account for almost 10% of the global disease burden but virtually no new medicines are being developed, and drug resistance is wiping out the drugs we have,” he emphasized.

This acute lack of drug R&D into unprofitable diseases can be illustrated in new data that reveals that of the 1,393 new drugs approved between 1975 and 1999, just 13 or 1% were for tropical diseases.

In 1999, MSF convened an international body of health experts to study the current state of drug R&D for diseases that affect people in the developing world. This independent body is called the Drugs for Neglected Diseases (DND) Working Group.

The survey results came from this working group and the Harvard School of Public Health survey of 20 pharmaceutical companies in Europe, Japan and the United States.

The survey made enquiries about the overall resources devoted to infectious diseases and specific resources devoted to R&D activities for five neglected diseases, namely, malaria, tuberculosis, sleeping sickness, Chagas disease and leishmaniasis.

According to MSF, a disease can be considered “neglected” or even “most neglected” when treatment options don’t exist or are inadequate.

MSF blames this neglect on market and public policy failure. Strategies must be developed to address neglected and most-neglected diseases specifically, MSF points out.

The report explores the failure of the public sector to take a needs-based approach to managing drug development. Basic research leading to discovery of compounds - and thus potential drugs - has almost always been publicly funded, says MSF.

However, MSF notes, because politicians naturally respond to the needs of their constituencies, and because wealth is concentrated in industrialized countries, research money goes to the diseases primarily affecting these wealthier constituencies.

For example, says MSF, the current global system works well when it comes to developing drugs for diseases like cancer and heart disease or even for conditions like baldness and impotence.

But, when it comes to diseases affecting people with low purchasing power, investments are not so readily forthcoming from private industry.

While some government money has been devoted to diseases affecting developing countries, MSF says that it is a pittance compared with overall spending on drug development.

MSF holds governments accountable for correcting the fatal imbalance. They must become directly and proactively involved in searching for solutions at the global level.

Capacity building and technology transfer projects to increase R&D expertise in developing countries should be actively pursued, recommends MSF.

“Drugs are not developed according to public health need, but according to profitability,” laments Dr Pecoul, who adds that a new paradigm is urgently needed to address this fatal imbalance.

The report goes on to make some recommendations on redressing the imbalance and for moving forward, namely: that a well-defined and needs-driven research agenda be established at a global level; that governments fulfill their responsibility to become directly and proactively involved in searching for solutions; that funding be increased for research into neglected and most neglected diseases; and that a new not-for-profit initiative be explored as one way to address the shortage of R&D for the most neglected diseases.

MSF is also playing an active role in that it is exploring the creation of a Drugs for Neglected Diseases Initiative (DNDi) that will focus exclusively on drug development for neglected diseases.

As part of these efforts, MSF is funding three pilot drug development projects on drugs for malaria, leishmaniasis and sleeping sickness. These projects involve experts from Brazil, Thailand, Malaysia and Burkina Faso. – SUNS4984

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