[e-drug] Re: US compusory licensing proposal for medicines (cont)

[John Urquhart <urquhart@ix.netcom.com>]

E-drug: Re: US compusory licensing proposal for medicines (cont)
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[The moderator had this comment sent to her personally in response to the 
debate: 'Today's e-drug by Dr Leo Offerhaus is one of the best replies to
"Unlimited greed has to be incentive to develop new drugs". The 
dysfunctional Pharmaceutical Industry/Market  of the US cannot be held as 
the chief driver for pharmaceutical innovation. I must say looking at 
innovation in health as being better the more it brings to shareholders is 
very depressing. Just look at what Joel quoted on the medical value of the 
drugs being 'innovated'. Me too's lifestyle diseases etc. No new drugs for 
the major diseases. Not even a tiny fraction of their huge profits is going 
to such useful research. The figures to be expected from Tufts will be 
interesting and I hope posted on E-drug and the other lists as soon as they 
are out. KM]

In respect to Joel Lexchin's comments about Canadian compulsory licensing, 
the
long and short of it is that Canada is not a big enough country to impact 
on
the overall economics of drug development.

Historically the research-based pharma industry has led all industries in
shareholder returns, which makes attractive the investment in the high-risk
business of new drug discovery & development.  The risks are real, 
reflected in
the public record of product withdrawals, failures in phase III testing, 
and of
course many failures in the transition from animal testing to human 
testing,
and in phase II.  If the returns are diminished, the risk-reward ratio 
changes,
and investment tends to go elsewhere.  It is not a dichotomous function, so 
it
doesn't just shut off at a certain level of return.  One would be dead w  
rong to
form public policy on the assumption that the exuberant investment in 
pharma
R&D in the past several decades is not a direct consequence of the 
prevailing,
strong economic incentives.  It applies not only to "big pharma", but also 
to
the large number of newly-formed start-up firms that are taking risks even 
the
biggies won't undertake.  For example: Durect, Depomed, Surromed, Affymax
(later bought by Glaxo), Affymetrix, Maxygen, Biocardia, and, in a somewhat
earlier time, ALZA, Key, and Elan, which pioneered drug delivery systems..

As far as Dr. Offerhaus's comments go, he confuses 'invention' with
'development'.  The NCI may have identified taxol, and an academic 
medicinal
chemist here or there may have identified useful molecular structures, but 
that
is research at the level of the $50-100K per annum grant level.  It takes 
some
multiple hundreds of millions of dollars to develop the taxols, statins, et 
al.
into registered products for clinical use.  The Tufts Center for the Study 
of
Drug Development is soon to publish its latest compilation of statistics on 
the
costs of drug development -- key data that will inform this kind of debate.

A good example of how not to develop pharmaceutical products was the 
program
the NIH ran for many years in an effort to develop anti-epileptic drugs, 
which
the industry had neglected, mostly because the economic prospects were too
small.  The record of that effort and of other public agencies in achieving
complete development of pharmaceutical products is in fact very poor.  The
Population Council's development of the implant that became NORPLANT is a 
case
study in long drawn-out develpment and poor design.  (There's a description 
of
this ill-fated program in the review article I wrote on drug delivery 
systems
for J Internal Med last fall -- vol 248: 357-76, 2000)

Jim Black, by the way, discovered and oversaw the development of 
propranolol at
Imperial Chemicals (ICI), and then discovered and oversaw the development 
of
cimetidine at SmithKline -- he was not working in an academic environment 
when
he made these two key discoveries, which were the bases for his later Nobel
Prize.

John Urquhart, MD, FRCP(Edin)
Professor of Pharmaco-epidemiology, Maastricht University, Maastricht, NL
Chief Scientist, AARDEX Ltd/APREX Corp, Zug CH & Union City, CA, USA
Professor of Biopharmaceutical Sciences, UCSF, San Francisco
urquhart@ix.netcom.com

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