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[e-drug] GSK Access to Medicines: The Good, the Bad, the Illusory (2)

E-DRUG: GSK Access to Medicines: The Good, the Bad, the Illusory (2)
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With respect to Professor Baker's excellent and well-reasoned message/analysis, 
I wish to add my own feelings about making medicines available to those in need:

1. I applaud GSK for their efforts.  They are well thought out and - to my best 
observation - this is probably about the best a Big Pharma company can do for 
emerging economies.  And, it will possibly multiply the overall resources 
available for drug discovery in neglected diseases.  I worked for 10 years at 
GSK and the people there were well meaning and their science is second-to-none.

2. But, we cannot ask Big Pharma to produce the huge range of modern medicines 
for emerging markets.  This does not fit their cost model (their production 
costs are way too expensive) and it puts an unreasonable burden on companies 
whose existence is to bring NEW medicines to the world.  

3. Effective medicines exist for most of the diseases the put such crippling 
burdens on emerging economies.  There is a significant pool of money available 
for their purchase (UNITAID, Global Fund, PEPFAR, and other donors).  Access 
must still become a reality at the same time that more effective medicines are 
being discovered.

4. The generic companies of India, Brazil, China, Thailand and, increasingly, 
Africa are among the areas where regional production is emerging.  These 
companies are important - their cost models provide us the least-expensive 
access to Quality medicines - if we help them ensure QUALITY as well as price.

5. Big Pharma needs to support, or at least, not interfere with building 
capacity for essential medicines production in areas where they are needed.  
This is not a commercial loss for Big Pharma, these markets cannot support 
innovator prices (even reduced ones) and these markets go beyond 50 countries.

Examples of Big Pharma reaching out for this purpose already exist.  One such 
is Lilly's technology transfer for cycloserine, both for API and finished dose 
production.   And these efforts are fantastic.  But, even in India and China 
the prices for drugs for malaria and TB are driving the generic providers out 
of the market - costs do not justify the investment for scaleup and ensuring 
Quality.

In our near future, the singular problem of "CMC" (Chemistry, Manufacturing and 
Controls) must be solved with education and capacity building in Africa, 
Southeast Asia and South America in order to support putting finished medicines 
on the shelf for those in need.  This is going to take investment in areas 
other than drug discovery and Clinical.  Whoever produces medicines cannot LOSE 
money in the process.  Part of our overall effort in these areas is to enable 
the lowest-possible production of high-quality essential medicines for all 
purposes.  The new realization takes into account that hypertension and many 
other chronic diseases are important as well.

My thanks for the opportunity to send this message through e-drug.

Joseph M. Fortunak
Associate Professor
Chemistry and Pharmaceutical Sciences
Howard University
525 College Street NW
Washington, DC 20059 USA
+1 202 806 6880 (office)
+1 301 928 7568 (mobile)
jfortunak@comcast.net

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