16 Drug Development Research

in Women

Lionel D. Edwards

16.1 Background

The pharmaceutical industry is in the business of
developing, manufacturing and selling drugs, vac-
cines and devices. Although basic research has
become more important in recent years, it is not
the primary aim of industry. However, increasingly
and usually dictated by opportunity, industry is
investing in a highly targeted fashion in some
aspects of basic research, but the development of
a product is always to the fore. This thrust, how-
ever, need not exclude the gathering of basic data,
which may prove invaluable to the research
process. Regrettably, these data were frequently
inaccessible, in some instances owing to the
needs of confidentiality, product protection or
even legal concerns, but by far the greatest reason
is that such data are regarded as a by-product,
almost ‘waste data’, for they are not part of the
mainstream of product development. Such data are
recorded but rarely utilized, frequently residing in
notebooks, case records, mainframe databanks,
statistical reports or data tabulations in the back
of appendices of regulatory submissions.
So it is with gender data: it is collected, analyzed
and tabulated by each study and by each drug, but
data on drugs of the same class and between each

government agency handling multiple applications

are virtually inaccessible. Mining these data

requires more creative solutions than ‘regulations’.

This is now happening.

It has been estimated that the average cost of

developing a new medicine is now $805 million

(DiMasi, 2003). This estimate mostly comprises

costs in development, but includes the loss of other

revenue if the development money had instead

been invested cumulatively. These costs are passed

directly on to the consumer.

Drug costs have risen slowly compared to other

health costs, when adjusted for inflation. When com-

pared to other health costs, in 1965, the drug/device

cost was less than a dime per health dollar and in

2004, it was less than twelve cents (Health Care

Financing Administration). Drug cost is, and must

remain, one of the most affordable aspects of treat-

ment. A large component of drug development cost

is caused by regulatory needs to test for drug safety

and efficacy, both for the USA and foreign agencies.

Clearly, the cost of any additionalregulation imposed

on top of the current burden will also be directly

reflected in the eventual cost to the consumer.

Women comprise 51% of the population of most

nations. According to the United Nations, the

global female population will increase by 48.4%

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9