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[e-drug] Novartis case and R&D: Brian Druker on development of Glivec

E-DRUG: Novartis case and R&D: Brian Druker on development of Glivec
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[Dr Brian Druker was a key researcher behind the discovery and development of 
Glivec, the medicine that triggered the patent dispute in India against section 
3d of the patent act. This article discusses his thoughts on the issue of 
patents and access to medicines. 
It was published yesterday in the Mint a leading financial daily in India. 
Thanks to Buddhima for posting. Copied as fair use. WB]

http://www.livemint.com/2007/08/15003521/Don8217t-abuse-patents-sci.html

Don't abuse patents: scientists

The public sector has a key role in drug R&D. Patenting minor changes to extend 
monopoly prices spells misuse

Brian Druker

In the recent debates on patents, pharmaceutical prices and access to essential 
medicines, the critical role of scientists and resources of the public sector 
and academic institutions involved in medical research have often been 
overlooked. As one of the scientists behind the development of the medicine 
'imatinib' (marketed as Glivec by Novartis), which has allowed the effective 
control of a devastating form of cancer, I have witnessed the vital role that 
academic researchers and public institutions play in bringing new medicines to 
the market.

Many scientists, if not most of those I have collaborated with in these 
settings, are engaged in research primarily motivated by the pursuit of 
knowledge as a means to help patients. For many of these scientists it is, 
therefore, of great concern that the results of their efforts can't reach 
patients and save lives because of pricing strategies and patent policies such 
as "patent evergreening" (minor changes to existing molecules designed to 
extend patent monopolies) used by partners further down the drug development 
process.

Chronic Myeloid Leukemia (CML) is a disorder of blood cells that transforms 
through an "accelerated phase" to an invariably fatal leukemia. Imatinib has 
radically improved the success of treatment for this disorder and patients 
treated with the medication can retain a high quality of life. The development 
of this drug is a journey in scientific discovery that highlights the 
collaborative and open process of innovation, where both the private and public 
sectors play an indispensable role. The marketing approval of imatinib was the 
result of research conducted over decades, marked by international 
collaboration of scientists from different academic institutions and the 
private sector.

The basic research that led to the identification of enzyme inhibitors for CML 
dates back to 1960 with the identification of the Philadelphia chromosome in 
patients with CML by researchers at the University of Pennsylvania, Peter 
Nowell and David Hungerford. In 1973, Janet Rowley at the University of Chicago 
determined that the abnormal chromosome was due to a translocation of genetic 
material. In the 1980s, several labs, including my own, played an important 
role in showing how the Philadelphia chromosome produced a cancer causing 
protein (Bcr-Abl). This research also clearly suggested that the selective 
blockade of the Bcr-Abl enzyme could provide a means to control and prevent the 
progression of CML.

In the late 1980s, I began collaborating with industry scientists at Ciba-Geigy 
(now Novartis Pharmaceuticals) who were developing inhibitors for the class of 
enzymes to which Bcr-Abl belongs. Both the scientific community and the pharma 
industry were highly sceptical of the utility and selectivity of these enzyme 
inhibitors, and interest was limited. Despite this, I suggested that the CML 
enzyme (Bcr-Abl) would be an ideal target for therapy.

In 1993, I moved to Oregon Health Sciences University in Portland and had a 
single goal of finding a company that had the best inhibitor for Bcr-Abl and to 
bring it into clinical trials. My work in Oregon on a therapy for CML was 
primarily funded by public sources, particularly the National Cancer Institute. 
My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the 
development of imatinib on their agenda despite uncertainty from product 
managers. As imatinib progressed through early and late clinical trials and 
demonstrated outstanding results, scientific and media interest in our 
discovery increased. The approval of imatinib by the FDA in May 2001 for use in 
CML was the culmination of a 10-year project for me, something I had dreamed of 
since medical school.

However, the price at which imatinib has been offered for sale by Novartis 
around the world has caused me considerable discomfort. Pharmaceutical 
companies that have invested in the development of medicines should achieve a 
return on their investments. But this does not mean the abuse of these 
exclusive rights by excessive prices and seeking patents over minor changes to 
extend monopoly prices. This goes against the spirit of the patent system and 
is not justified given the vital investments made by the public sector over 
decades that make the discovery of these medicines possible.

Public institutions around the world have continuously played a critical role 
in the research that leads to vital new medicines reaching the market. Without 
access medical research becomes a luxury good. Most of my colleagues would be 
very uncomfortable if we felt that this would be the result of our decades of 
effort.

Brian Druker, chair of Leukemia Research and professor of medicine at the 
Oregon Health and Science University Cancer Institute, is recognized as the key 
researcher behind the discovery of STI571 or imatinib (marketed as Glivec by 
Novartis). 
Comment at  theirview@livemint.com

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