[Ip-health] Rowan Gillies and Ellen T Hoen in the Financial Times: Patients' needs are what must drive drug research

[Thiru Balasubramaniam]

http://news.ft.com/cms/s/0ba21e04-eb8b-11da-823e-0000779e2340.html

<>Patients' needs are what must drive drug research
By Rowan Gillies and Ellen T Hoen
Published: May 25 2006 03:00 | Last updated: May 25 2006 03:00

Acursory 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, M=E9decins Sans Fronti=E8res' 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 forgovernments and the WHO finally to do so.

Dr Rowan Gillies is international president of M=E9decins Sans Fronti=E8res=
.
Ellen 't Hoen is director of policy and advocacy at the MSF campaign for
access to essential medicines