1990s have seen the impact of enabling biomole-
cular technologies, such as combinatorial chemis-
try, genomics and high-throughput screening, and
computer-assisted drug design, and so in the 1990s,
we have basic pharmaceutical discovery being
carriedout at themolecular and diseasemechanism
level. As such, we now have many models to
evaluate and have probably reversed the develop-
ment paradigm to one that Dr Stanley Crooke, the
Chief Executive Officer of Isis, has described as
‘target-rich [but] chemical-poor’.
Inevitably, in today’s world, where science
seems to be producing amazing advances almost
weekly, the focus is on R&D and further improve-
ments in healthcare in the future. This should not
cause us to take our eye off the needs of today and
the ability of today’s medicines to be used most
effectively. The value of a new therapeutic agent is
not maximal at the time of its first approval. Much
can be done after market approval to ensure that a
new drug’s utility is both fully understood and
actually realized. The physicians within pharma-
ceutical medicine need to oversee and lead this
process. This requires that they are trained in eco-
nomics and business as well as medicine. Indeed,
some may well go on to specialized courses in
those areas leading to diplomas and even university
degrees.
The rapid advances in the biosciences and our
gains in the understanding of diseases offer the
opportunity of new benefits or uses for drugs to
be developed after they have been marketed. Con-
sequently, there is a real and ongoing role for those
in pharmaceutical medicine to follow the advances
of medical sciences and improve the value of the
drugs of today within the medical and healthcare
practices of tomorrow. This ‘evergreening’ process
is analogous to physicians in their practice learning
about a therapy and, as they come to know more
about the use of the treatment and their practice
dynamics change, modifying the use of that ther-
apy to the maximum benefit of patients.
The management of a drug on the market is a
professional challenge for which no medical
school trains its physicians. The overall process
and skill is an important part of the training within
the speciality of pharmaceutical medicine. This
effort may include the issues of quality-of-life
evaluations, together with the appropriate develop-
ment of evidence-based medicine, of outcomes
research and cost–utility sciences. All of these
are techniques needed within pharmaceutical med-
icine. Used appropriately, they can help not only to
establish the curative value of a new medicine but
also to ensure that the therapy gets delivered opti-
mally.
Just as is one’s personal practice of medicine,
there is no more rewarding experience than the
optimal use of a treatment modality in a complex
clinical case with a successful outcome and a
happy patient; there is an equivalent reward in
pharmaceutical medicine for a physician who posi-
tions a product to deliver the best benefit for all
patients, convinces all those delivering the care to
use the product, and sees a consequent real
improvement in society’s level of healthcare. In
the past, many good therapeutic agents have not
been used as or when they should have been. This
was not because patients in trials have not been
benefited, rather because thevalue message had not
been positioned adequately for the care providers
and/or for thosewho have to manage the healthcare
resources of our societies. Even when well devel-
oped and appropriately used for their approved
indication, many drugs take on a new lease of life
as medical sciences change and new therapeutic
uses become possible; for example lidocaine was a
very well-known local anaesthetic and was in use
for decades when it found a new role as an antiar-
rhythmic within the new context of cardiac resus-
citation and coronary care units.
By the same token, as medicine progresses, the
acceptability and safety of a drug can change. It is a
basic axiom of pharmaceutical medicine that no
drug can ever be considered completely safe. This
is true no matter how much human-use data is
available. For example, PhisoHex (hexachloro-
phene) gained broad usage as a skin wash and
scrub to combat the spread of infection. It was
used in paediatric and neonatal units in hospitals,
by nurses and surgeons, as a scrub and was even
sold over the counter as a teenage acne remedy.
Notwithstanding all this, it became a safety
issue. This was because, as medical science
advanced, more and more premature babies were
able to survive. The skin of these babies wasCH2 PHARMACEUTICAL MEDICINE AS A MEDICAL SPECIALTY 13