Principles and Practice of Pharmaceutical Medicine

obesity, attention deficit, hyperactivity and even
anorexia/bulimia. As the patients or their represen-
tatives respond and ‘take charge’, we should not be
surprised to see a change in what are considered
therapeutic modalities and how they are made
available. We might expect a demand for products
that do not need prescriptions (e.g. minerals, neu-
traceuticals and cosmeceuticals) or for patients to
be able to self-diagnose and use prescription drugs
moved to a ‘pharmacy only’ or to a full OTC status.
Some of these moves may well fit within one or
more governments’ desire to reduce the national
pharmaceutical bill and hence may be something
that has both patient and provider endorsement.
Those seeking to develop therapeutic products
will need to understand these dynamic interactions
and the consequent potential changes in one or
more of society’s approaches to its healthcare.
Indeed, this is another opportunity for pharmaceu-
tical medicine to expand. The speciality should
cover all pharmacologically active treatments, all
disease preventions and all health maintenance
modalities. The objective is to maximize patient
benefits and extend product life cycles, as well as
company sales. Clearly, pharmaceutical medicine
requires an ability to read the direction society is
taking and an understanding that, on a global basis,
various societies can take different attitudes to how
they will regulate and/or classify a therapeutic
agent. However they are classified or regulated,
new therapeutic agents will continue to be needed,
health benefits to delivernowand to be potentially

significant revenue generators for a business,

allowing investment in future therapeutics. This

is the basic cycle (Figure 2.2) that drives the phar-

maceutical industry.

The R&D process is moving forward as biome-

dical science progresses and disease processes are

better understood. The process of developing a

therapeutic agent is much more than a better under-

standing of a disease leading to a new approach to

its management. The process includes the follow-

ing: first, state-of-the-art technical manufacturing

sciences to ensure a drug substance is pure; second,

appropriate and innovative pre-clinical science to

ensure that a new chemical entity is as safe as

possible before being used by humans; third, the

most sophisticated clinical evaluation methodol-

ogy, which must establish the efficacy and safety of

a new treatment in humans and include a multi-

disciplinary approach to medical, social and eco-

nomic issues of quality of life and cost–benefit.

Finally, the process includes the business manage-

ment of social and political issues inherent in

establishing, communicating and assuring the

value of the new drug within a global economy.

The amount spent on R&D by the pharmaceu-

tical industry has grown logarithmically over the

past few decades, and now the industry outspends

the National Institutes of Health in the United

States (Figures 2.3 and 2.4).

Similar growth in R&D investment has been

seen outside United States, for example in the

United Kingdom. With such a massive R&D effort,

Stronger stock

with ability

to raise money/reinvest and

build a self-sustaining company

Development

innovation

New

knowledge

Better

products

More satisfied

customer (patients,

health professionals etc) Improved quality

of life

More product use

and

more profits

Wealthier

shareholders

Figure 2.2 The cycle that drives the pharmaceutical industry

10 CH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY