May 24, 2006
Patients' Needs Are What Must Drive Drug Research
This article appeared in The Financial Times. All rights reserved.
By Rowan Gillies and Ellen 'T hoen
A cursory glance at the developments of recent years would suggest that things are on the mend in the world of medicine. The pharmaceutical industry is coming up with new blockbusters — with the latest a much-trumpeted — "miracle" drug against obesity. Neglected diseases — such as tuberculosis, sleeping sickness and kala-azar, for which industry sees no sufficiently lucrative market to justify investment in research and development — are seemingly catered for by partnerships to develop drugs, diagnostics and —vaccines.
Big pharma uses these developments to boost its tattered image. The dark days of 2001 seem long gone, when more than 40 companies took the South African government to court in a misguided attempt to protect profits in the face of the country's efforts to provide cheaper Aids treatment to its people.
The impact of these changes may be heart-warming to shareholders but what of their consequences for patients? Any change in the desperate situation faced by patients in developing countries has been, at best, minimal. An article in the medical journal The Lancet this month shows neglected diseases are still very much neglected, with only 1 per cent of drugs reaching the market between 1974 and 2004 addressing these conditions. Product-development partnerships may have succeeded in filling their pipelines with promising drug candidates, but activities are insufficient compared with the magnitude of the crisis. The partnerships largely depend on philanthropic funding, highlighting a lack of public priority-setting and leaving a considerable funding gap.
Meanwhile, Médecins Sans Frontières' experience in our field programmes shows how neglected diseases continue to wreak their deadly toll. In the absence of a reliable and suitable test for tuberculosis, patients continue to go undetected and die. Those who are diagnosed are treated with a lengthy and increasingly inefficient regimen dating from the 1950s and 1960s. The most common treatments for sleeping sickness and the parasitic disease kala-azar both rely on drugs with potentially lethal toxic side-effects. Even Aids is a neglected disease — we still have no suitable diagnostic tool for infants and no appropriate medicines for children.
This is because the system that drives research and development today steers investment towards areas of guaranteed profitability. It is a system in which governments fail to set the priorities for medical research. It is a system in which there is no attempt to find a balance between global medical need and resource allocation. And it is a system entrenched in intellectual property regulation and trade agreements, which a World Health Organisation commission concluded in April show no evidence of boosting R&D in pharmaceuticals for diseases affecting developing countries.
But patients in rich countries are losing out, too. For this is also a system in which those doing the R&D are rewarded more for developing a drug that will sell than one that will meet unaddressed health needs. A spate of recent evidence shows how the therapeutic significance of recently marketed products is declining. A survey in April 2005 by the French journal La Revue Prescrire concluded that 68 per cent of the 3,096 new products approved in France between 1981 and 2004 brought "nothing new" to existing treatments. The British Medical Journal published a study rating barely 5 per cent of all newly patented drugs in Canada as "breakthrough". A breakdown of more than 1,000 new drugs approved by the US Food and Drug Administration between 1989 and 2000 revealed that more than three-quarters had no therapeutic benefit over existing products.
It is high time for the WHO to address this problem. As health ministers gather in Geneva for the World Health Assembly this week, they will discuss a resolution proposed by Kenya and Brazil for a "global framework for essential health R&D". The resolution calls on governments to establish mechanisms that ensure medical research addresses the health needs of patients and not commercial dictates; that it delivers affordable products; and that it attracts sustainable long-term funding that is equitably shared among countries. When the system is broken, you fix it — now is the chance for governments and the WHO finally to do so.
Dr Rowan Gillies is international president of Médecins Sans Frontières. Ellen 't Hoen is director of policy and advocacy at the MSF campaign for access to essential medicines.