15 Drug Research in Older
Patients
Lionel D. Edwards
15.1 Demographics
The elderly (over 64 years old) comprise 12% of
the US population and 17% of Sweden and Japan.
This sector continues to grow. In the United States,
it is estimated that the elderly population will grow
to 14% by the year 2010 and reach 17% by 2030
(US Bureau of the Census, 1996). This, together
with their known sensitivity to medications
(Everitt and Avorn, 1986), contributed to accep-
tance by industry of additional requirements for
testing in the elderly.
The US Bureau of the Census, International
Database (1996) (National Center for Health Sta-
tistics, 1996) projected that, for the year 2020, the
less-developedcountrieswouldcontainonly16.4%
oftheworldpopulationcomparedto27.1%in1996,
and that by 2020 the mean age of the population in
more developed countries would be 42 years, up
from 36 years in 1996. In developed regions, the
elderlywouldoutnumberyoungchildrenby8:1,for
example in Italy, based on current fertility and
survival rates, only 2% of the population would be
five years or younger, but 40% would be 65 years
and older.
Therewereevenmorestartlingprojectionsbythe
United Nations International Population Division
(1996). They projected life expectancy in the
‘developed’ countries to reach 81 years by 2050.
For less-developed countries, this would still reach
76 years. However, this increase in the global
elderly population would be proportionally offset
by a decrease in fertility rate, now under way, from
1.7 births per woman down to 1.4 in the Western
world. This is below the replacement rate. For Sec-
ond World regions, the rate of about 3.3 births per
woman would decline to 1.6. Even in the least
developed (Third World) countries, five births per
woman would fall to two by 2050. Thus, the whole
world would actually start to ‘depopulate’ in
40 years.
The social and healthcare impact of these demo-
graphics in the United States and across the globe
will lead to an increased demand for better medi-
cines directed at a healthy old age. This elderly
population have more income than average per
capita income. In the United States, 70 million
‘baby-boomers’ are starting to retire to a total of
86.7 million retirees, 21% of the population (US
Administration on Aging, 2005). In addition, with
more time on their hands to lobby, they are more
likely to vote, and can be expected to use their
political muscle to make demands on their govern-
ments. The governments will respond in the usual
knee-jerk reaction – ‘more regulations and con-
trols’ on industry – while increasing funding for
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