more permeable than that of full-term babies, chil-
dren or adults. There was therefore a new poten-
tially ‘at-risk’ group. Hexachlorophene toxicity in
humans was considered to have resulted, and this
led to the product being modified or removed in
many markets worldwide.
The scale of the response to this issue provides a
case history that highlights another skill and train-
ing required within pharmaceutical medicine,
namely crisis management. This is a very impor-
tant technique which is critical in addressing sub-
stantive health issues. In a relatively recent history
of healthcare, there have been several such issues,
for example Zomax, Oraflex, Tylenol tampering,
toxic shock syndrome, Reye’s syndrome, the
Dalcon shield, contaminated blood supply, silicon
implants and the so-called ‘generic drug scandal’,
to mention but a few.
Today, as much as being a leader in R&D, it
is part of the role of a pharmaceutical physician
to recognize new opportunities and to be alert for
any emerging evidence of potential added benefits
and/or new safety issues, as products and those of
competitors are used more broadly outside the
confines of clinical trials.
Many of the areas of expertise needed in phar-
maceutical medicine overlap with the expertise of
other medical disciplines. The most obvious over-
lap perhaps seemed to be with clinical pharmacol-
ogy. Indeed, clinical pharmacologists have a real
interest in the R&D of the pharmaceutical industry
and their training is good for entry into the industry.
However, clinical pharmacology is by no means
the entirety of pharmaceutical medicine. Indeed,
some pharmaceutical physicians will work in even
more basic and theoretical science settings, whilst
others will work in more commercial settings. Of
course, many within the speciality can and do focus
on the development of disease models and the
evaluation of new chemical entities in these dis-
eases. The most modern methods in such areas are
vital to the successful development of new drugs,
and the continued and continuous interaction
between the industry and academia is absolutely
necessary.
Indeed, the distinction between academia and
pharmaceutical medicine is becoming blurred. The
pharmaceutical industry R&D effort is now lead-
ing to Nobel prizes being awarded to those in the
industry for pioneering work on subjects as diverse
as prostaglandins, anti-infectives, and pharmaco-
logical receptors such as the histamine and the
b-adrenergic receptor. The direct interaction
within a company between those involved in
basic research on receptors, active sites or genetic
code reading sites, those synthesizing new mole-
cules, and those testing them in the clinic, leads to
the potential for a very fruitful research effort.
Naturally, the industry as a prime inventor has
the opportunity to carry out seminal work with
entirely unique concepts, even if many of them
do not become therapies for humans. Human is
a unique animal which can, and does, exhibit
unique responses to a new chemical entity. No
pre-clinical work can be entirely predictive of a
successful response in the clinic, and there can, in
the end, be no substitute for human testing. Some
products fail because of safety problems specific
to humans, and some because the early promise of
efficacy in model systems is not realized in
humans.
Those who join this new speciality may come
from many medical backgrounds and can well
spend much of their time doing things other than
pharmacology. In a very real way, those in pharma-
ceutical medicine are practicing medicine. They
are responsible for the products of the pharmaceu-
tical industry that are in use today. As such, they are
influencing the health of far more people globally
than they ever could in the context of their own
individual clinical practice.
Any discussion of the discipline of pharmaceu-
tical medicine today would be incomplete without
a comment on the impact of biotechnology and the
burgeoning biotechnology revolution. This is a
revolution that is driven in a very different way
than that in which the pharmaceutical industry has
classically been run. The prime drivers are a multi-
tude of small venture capital companies which are
espousing the very cutting edges of research in
biologics, genetics and technology. They are lar-
gely managed by a combination of bioscientists
and financiers. In this context, the role of pharma-
ceutical medicine takes on its most extreme var-
iants. At one end are physician/scientists, who are
the research brain of the venture, and at the other14 CH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY