Principles and Practice of Pharmaceutical Medicine

attitudes to what they can and should expect of
physicians. Today, we are very much moving
towards a balance in the therapeutic interaction,
if not to a patient–doctor relationship. This change
is a seminal one for the delivery of healthcare and
for the development of new therapeutic agents.
For prescription drugs, the major factor bringing
about the involvement of patient groups was prob-
ably the revolution in the new drug evaluation
process caused by the AIDS epidemic. This terrible
affliction occurred at a time when groups within
society were forming to fight for their recognition
and/or rights quite independent of the occurrence
of a life-threatening disease. Nonetheless, within
the Western world, it is clear that these groups
rapidly came to form a vanguard for patients rights
with respect to AIDS. They challenged the patern-
alism within medicine and insisted on access and
full disclosure of what was going on in pharma-
ceutical medicine and within academic medical
politics. Without this openness such patients
would have lost confidence in pharmaceutical
companies, the academia and the medical and
regulatory establishments. Having forced a re-
evaluation and a greater respect for patients’
needs, AIDS Coalition to Unleash Power
(ACTUP) and others have brought patient repre-
sentatives into the drug development process. Such
educated and involved patients have, in their turn,
come to understand the scientific methodology and
the requirement for the adequate testing of new
drugs. Indeed, the requirements have consequently
become much more acceptable to patients in gen-
eral. Nevertheless, there is no doubt that these
proactive patient representative groups have for-
ever changed the role of the patient in the develop-
ment of therapeutics and of healthcare within
society.
Pharmaceutical medicine is the discipline that
specializes within medicine in overseeing the pro-
cess of developing new therapeutics to improve the
standard of health and the quality of life within
society. Inevitably, then, it was one of the first
medical specialities to feel this change in patients’
view of the quality of their care. An integral part
of all progress in healthcare is evaluating the
needs of patients and society and the gaps in the
present provisions for those needs. To oversee this

progress, pharmaceutical medicine involves the

combination of the following: first, the medical

sciences to evaluate disease; second, the economic

sciences to evaluate the value with respect to costs;

and third, the ethical and social sciences to evaluate

the utility of any new drug to patients and to society

as a whole.

As with all products, truly successful therapeutic

agents are those that meet all the customers’ needs.

In today’s and tomorrow’s world, the concept that

all that is needed is for medicines to meet the

scientific requirements of being effective and safe

is essentially an anachronism. It is not just the

scientific factors and customers that must be satis-

fied. Table 2.1 shows that the two other critical

factors or influences outlined in Figure 2.1 produce

many more customers to be served.

As members of the public become generally

more and more informed, it is inevitable that they

will want to take more of a role in deciding on their

own health and how any disease that they might

have is to be treated. It is important to realize that

this is likely to change the demand for healthcare.

Some of the focus will shift to areas not classically

considered as diseases or to health areas considered

today as an inevitability of life or a condition for

which the patient should ‘just take charge’. Typical

examples will be, on the one hand, an increased

focus on the quality of life or on the effects of

ageing (such as cognitive dysfunction, menopause,

osteoporosis and waning immunological function,

with consequent increase in vulnerability to dis-

ease), and, on the other hand, disorders such as

CH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY 9

Table 2.1 Controlling factors in the adoption

of new therapeutic agents

Influences Controllers/‘gatekeepers’

Medical science Regulatory agencies

Physicians

Health professionals

Healthcare providers Politicians

National health

services/HMOs

Insurance companies

Consumers Patient groups

Pharmacists

Media