costs of additional research would add to the
already enormous cost of drug and devices
research. Second, the ever-present fear of litigation
resulting from perceived exploitation, coercion
and vulnerability of these special populations dis-
couraged industry and the FDA from policies of
inclusion.
Other influences determining research direc-
tions in drugs and devices were paternalism (pro-
tectionism) and the money available for grant
projects, guided by the numerical male dominance
in the reviewing process of research priorities.
For the pharmaceutical industry, it is ironic that
attention tothese special populations isnow proving
‘good business,’ either because of an extension of
protected patent life or the development of special
business units. These units have increased market
penetration and retention of drugs for third-party
reimbursement and allowed niche dominance. The
latest of the four major special populations rulings
by ICH, the final rule on Acceptability of Foreign
Data, was implemented in July 1998. Although it is
the latest, it will not be the last – the future impact
of the genome project on each of these major
demographic segments, and its influence on geno-
mic pharmacology and gene therapy with regard to
these ‘special populations’, has yet to be felt.
Each chapter will give a limited historical con-
text. The chapters dealing with drug development
in women (Chapter 16) and racial and ethnic popu-
lations (Chapter 18) explore issues of physiology
and metabolism in detail, because of the societal
sensitivity and a relative paucity of data in the
literature.
The chapters on geriatrics and pediatrics (Chap-
ters 15 and 17) focus mainly on the evolution and
requirements of the drug development process,
because data on the physiology and metabolism
of these groups are both widely known and easily
available in the literature.
The chapter on orphan populations described
what constitutes an orphan population and an
‘orphan drug’, the history of legislation, and the
current inducements for industry.
Lastly, although the chapter on drug exposure of
renal and hepatic impaired patients is an essential
part of most clinical programs (as a predictor of
drug pharmacokinetics in the elderly), it is
included in this section as these volunteer patients
are indeedspecialpatients.192 SECTION III SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES