Academic Clinical Pharmacology: Development, Current and Future Status JOHN
DURING
1971
and
Weintraub questionnaires
of
clinical
and
1972,
pharmacology.
data
gathered
Dr.
Michael
I sent out concerning An
has
been
three sets academic
abstract
a clinical
pharmacologist
of the
deans
returned
though some forms through pharmacology men. Table I shows mailing. had
Sixty-four at
least
and of pressed The
cology
in were
if
fied by concerning
clinical
clinical
deans their
pharmacology associated.
(60
and
sent academic
per
They
cent)
pharmacologist; 80 per a faculty
of the with
which
were
also
clinical were
well
the
clinical they asked
of
questionnaire,
places filled.
(Canadian
and
also
available Forty-two
for training, divisions
taken
reasonably by ASPET2
completed noted
fellowship
pharmaceutical
and
survey by the ASPET
In
it was
57
of
offering fellowships These divisions were
a survey
(1971),
identi-
pharmacology
123 fellows. figures correspond
with
N.Y.
shows the pharma-
States clinical
a more recently Pfizer Pharmaceuticals.3
the
a
included)
pharmacology identified.
survey
Rochester,
sent
United
number
training These
M.D.
Table II of clinical
not
that
the
NIH
positions
industry
and
supported
37. Table
III
lists
ganization
From the Department of Pharmacology and Toxicology, University of Rochester Medical Center, Rochester, N.Y. 14642. Presented in part at the Third Annual Meeting of The American College of Clinical Pharmacology Symposium on Clinical Pharmacology Consultations, Atlantic City, N.J., May 3, 1974. 1975
the
divisions, and places
identi-
to name their associates in clinical pharmacology. Eighty-six of the 97 responded (90 per cent); besides filling in the questionnaire, they named 65 associates. These 65 as-
November-December,
fies
also
the
supported
cent exmember.
a questionnaire lives and
structure
programs
al-
referred chairof this
pharmacologists were
organization were
schools
one
query,
had been department the results
the 43 without, a need for such 97
the
responded. profile
schools
not, whether he perceived a need for one; it also requested the name of his faculty’s clinical pharmacologist. One hundred per cent
were
and 55 numerical
Ques-
and,
MORGAN.
sociates
of the
published.1
tionnaire I, mailed to the dean of each of 107 medical colleges, asked if his faculty included
P.
and
of
data
clinical
indicates
a nearly
of affiliation
with
cology
internal
ing
and percentages
units are
all
monies.
pattern of pharma-
mean
and
activities,
the not
Respondents
The
fund-
values
for
all
fund
sources
just
fellowship also asked to of time spent.
were
in
orunits
medicine. are
activities
rank
the
complete
departments
reporting, for
concerning pharmacology
terms
It is clear that service ing, and consultation
functions, consume
time. The consultation
made clear that time on pharma-
cology visory Table
questionnaire included
and panels, IV
toxicology etc. gives
data
the
committees, from
responses
teachmost
adto 725
MORGAN
TABLE Response
I
of Medical
of
School
public
for
Deans*
policy.
support Faculty
includes
Yes=64 No=43 If
a clinical
pharmacologist:
no,
I
perceives
a need:
#{176}
Questionnaire
mailed
to
deans
of
107
medical
TABLE
pharmacologists original group
Divisions
of
Divisions
by
dean
named
as
associates
65
pharmacologists
The
Organization Pharmacology
of
Affiliated Clinical
162
pharmacology
clinical
for
Federal
fellowships
42
Foumidations
available
172
Total
fellowships
occupied
123
all
about
training
boards
in
of these relates answers
to a high degree regarding a clinical
and
a
clinical
were
clinical
in
internal
Only
Forty-eight
of
Finally, to
a
were the
in a year.
struck
us
Time
V of
as
cal
and
the
the It
the FDA
had
parthe
responses that indicates
pharmaceutiand
42
pharmacology
40 42
(per
cent) 38 25 23
4
decreasing
order
teaching teaching
Clinical
trials
Bench
research patient
tare
All other
with clinical
department affiliations
of medicine listed.
even
had
within
questions
interesting.
regarding
726
shows
attitude
of
activities
allotment,
TABLE Characteristics
represented.
trial
pharmacology
9
Primary
indiclinical
respondents
ambivalence industry
highly
clinical
Table
number
30
fellowship, clause”
of Clinical Units
33
medicine. This of positive subspecialty
appointments.
pharmacologists
activi-
and
by
listed all those appointments
Consultative/service
pharmaspecialty
discipline,
a clinical pharmacology cating that “grandfather
ticipated previous
and
clinical (42) had
and not
Consultation/contract
Preelinical
86 primary Nearly half
identified would
industry
Clinical
questions
comments
budget
Pharmaceutical
fellowships
ties of cologists.
few
grants
46
Total
the
an
III
with department affiliation*
University
clinical
that as
pharmacologists clearly with
TABLE
named
clinical colleges)
offering
clinical
II
Funding academic medical
a
of those questionnaires
replies degrees
Divisions pharmacologists
Total (64
felt
increased.
only
Some clinical
Number and Placement of Clinical Pharmacologists in United States Medical Schools
Clinical by
has
make
considered
others. with
colleges.
Clinical
support
most
pharmacology
discipline
macology. T1any many filling out
(l99
be *
clinical
would
little
and
about our survey. It probably represents an incremental distortion of clinical phar-
(81%)
No=3 No answer=5
is
board,
for
academic
(60%) (40%)
Yes=35
There
a specialty
questions
IV
of 86 Primary Pharinacologists
Specialty
Clinical
42
board
Ph.D.
18
Clinical pharmacology fellowships
30
Clinical
suhspecialty
53
Clinical
appointment
Participated trials
The
in in
last
Journal
76 clinical year
of
Clinical
48
Pharmacology
when
ACADEMIC
CLINICAL
PHARMACOLOGY
TABLE Attitudes
of Primary
Should there pharmacology
be
more units?
Should there pharmacology?
be
a
Has
support academic
the for
Is
FDA
in
the
there in
are
of their
mentor.
Rather
123
than
in
these
ing the programs
apparent to meet
macology,
I would
a definition
gathered
prefer
discipline
and
are
acteristics studied.
on
physical
jects, e.g., nonphysical
It e.g.,
Disciplines by observation
mentation.
Further,
classified stand it
to increase and, of
teach
Again,
November-December,
such our course, the 1975
ob-
based
on
organizational
5
43
42
1
45
22
19
41
37
8
28
51
7
can
may physical e.g.,
this slightly in mind,
geneous
mass
cal
referred
field
of
basis
or
micro-
more process physiology,
overgeneralized come to
disciplines
disciplines
gather
a
in
to as clinical
sciences. mentioned
the
and
organize
data
about objects disciplines
atrics), ology),
around special techniques and around manual skills
vague.
is
separate After
unclear.
all,
is (or
an
(radi(surour
distinctions
disciplines
infectious
microbiologist. a physiologist. ought
around around (pedi-
however, The
clinical
pert is also a ologist is clearly chiatrist
definition,
and
and are or-
e.g., around neurology),
diseases (rheumatology), (infectious diseases), of the population studied
of
medi-
They share the charabove: (a) Clinical
in a variety of ways, systems (cardiology,
terms
backhetero-
disciplines
around organisms the age
that
to underability to
Such
principally of the
anatomy
we
or clinical acteristics
perspective is
greatly.
pharmacology.
to
gather experi-
vary
depend characteristics
or it may be e.g., biochemistry,
gery). In
information ability our
11
studied,
disciplines and
70
ganized organ
processes based on
exist
5
orsuch
of
college
59
teach information processes. (b) Clinical
of char-
or be
may be psychology.
medical
are similar. information
a variety
characteristics
botany. data,
Traditional
any
22
are of The
of
the objects endeavor may
The
inherent
as
disciplines organization information.
7
discipline
With ground
of training clinical phar-
functions based
of
in-
project-
of Disciplines
and
the
biology, oriented,
an
or
21
a
unit
pharmacology.
scientific systemic
a
these
to speculate
clinical
as
organization upon the
trained
with
answer
pharmaceutical
subspecialty
inadequacy needs in
of
data
ganization
the
58
introduction?
that
of
No
an
of
being
numbers
Development
Academic based on
the
some
proceeding
of
in
No
data
used
drug
doubt
persons
fellows
terpretation
it.
a job
pharmacology; were
The
new
I seriously
really
trainees
be
department-what-
activities.
clinical
to
consider
pharmacology
their
efficacy
guidelines
obstructing
Yes
clinical as
relative
NAS-NRC legislation?
Would you industry?
ever
in
of clinical pharmacology discipline increased?
Should basis
Pharinacologists
clinical
board
Should the FDA require in new drug assessment
the
Clinical
industry-funded specialty
V
to be)
are
disease A
ex-
cardiA psy-
a sociologist. 727
MORGAN
Our clinical categorized
disciplines or identified
of the
performed
tasks
zation. This
blurring
discipline to
define
and failure
of
cipline.4’5 macologists,
Do
organizational sion
of
eme?
of do
who
dilemma is probably terms of an explanation for, and organization
best
around niques,
anything: microorganisms,
drugs. lishment
If
cal
discipline,
Clinical
do sub-
drugs
clinical organized
organs, and, in our
or
In fact, involves medical learning
assumed often the human education the
should plines
their
728
may
be
carried
or-
for
it
botany need
The and music not always
I disciinto
of
“gather charac-
education; howdo so. Interven-
change
changing example, a new
one dis-
entirely rheu-
in
category
reality of
although
clini-
often
still
status of clinical disciplines is not They change in organization and according to perceived need and
disciplines
They completely
in terms
cause their of course, leads
may
of data
gathered
genesis may may change. to
discipline:
a few (1)
of into
the the
Drs.
Prichard
small issue pharmacology cerned
with
drugs.
things
has what
Journal
about clini-
“characteristic” realm of service, (3)
We were because of
have
stated
is the “study human body and
to
drugs,
in like
that and point traditionally the
things or at
systems of interand societal, were the use of drugs. Turner
does
with
and
that
disease.”#{176} I would
Various The
change,
do are scarcely disby other disciplines.
and
body
and
and
statements
Some
that clinical pharmacology of what drugs do to the the
not, and from other
may vary in terms of intervention into systems. The factors
a perception that new vention, both individual needed revolving around
to
out (and
dis-
names;
is now
systems studied. They of methods and styles malfunetional human
health
die
a clinical
course,
of intervention. do not, vary
what
it is al-
characterClinical dis-
we now have At times a
least very applied research. created as a clinical discipline
out.
intervention.
formula can
The static. name
(2) Many we do fit
very process of study intervention. Clinical consists largely of
rules
have but
cal pharmacologists tinct and are shared
intervention.
add that other scientific may be geared to intervention
systems studied. data-classify-intervene” terize ever,
ill)
necessarily
This
ganization, appear to be based upon the gathering and cataloguing of information so that intervention into a malfunctional human system (usually an individual who is ill
may,
our
sciences
for intervention) health-related prob-
longer
without
that they,
techease,
the estabof a clini-
whatever
no
cipline
style often
understood in the impetus of, any clinical
it is probably
disciplines,
we
test
to
We
under
organizational
there is any key and enfranchisement
lems.
necessity illness or
cal immunology, called rheumatology.
of
diseases,
apparent human
subsumed
with
some
I believe
come into existence and of their ability to intervene
cipline of syphilogy, of radiation therapy.
mcdi-
of
but
and organizing disciplines.
a distinct us
I stated before, be confusingly
of
a goal all,
goal clinical
for
of
can
the
be at
matology,
accusation that from traditional trials? our
As may
we
an in
not
subdivi-
confront
in medicine
discipline. disciplines
a
Are
internists
ac-
a still dis-
from pharas ASPET’s
department
perform clinical The answer to
and
is Our
a peer
implies,
the
the statement or nothing differently specialists
failure
or even
pharmacology?
Why
our
ciplines because
we do relates to as an academic
chart
subdivision
clinical
do.
we really differ or are we in fact,
scientists
a
pharmacology
a public
what status
may
or ‘vays istic
pharmacologists
to have
tion
organi-
of to
clinical
clinical
ceptance uncertain
image
contributory
what
what
or by their
of
is
cannot be clearly by a distinctness
animal
out been body
pharmacologists of
Clinical
both
to take
Pharmacology
that condoes and
ACADEMIC
pharmacokineticists
have
of xenobiotics though such
for study
pharmacologists, To tabolism man
this and
have
ticular
and
arbitrarily is better of
and alclinical
(a)
last
two
decades
them.
new
drugs.
meand
scientists
be-
of cliniI would
state that clinical defined as a par-
study
of
the
impact
of
on
the human body. Further, it important because of the relarecent demand for new techniques approaches
on
by
human
trolled teclmiques
for
the
response
gathering
to
clinical trial), which we
of data
drugs
are
did:
animals
organization as a discipline.
Following that
drug
in
PHARMACOLOGY
fate
defines way,
studied any
style
drugs became tively
scarcely
disposition
been
the
years, interests
another
fore and after cal pharmacology therefore pharmacology
studied
many often
it
state
CLINICAL
(the
con-
to replace might label
older anec-
So my central point is finally clinical pharmacologists are most like clinical pharmacologists they
perform
drugs, trolled
therapeutic
evaluations
most often in the context clinical trial, although
of a connot neces-
cology.
I
choose
Obviously, cokinetic moved clusion
to
tion
of
that much
the market trafficking
drugs
only Is
drugs. clinical
those
not
metabolic
data are from value of
these
from
cal
pharmacology
that
the
and
often merely in therapeutics.
per-
pharmacological
a cardinal
role
Of
course.
changes is clearly
will
not
be
evaluative group of
of
for
de-
techniques psychotropic
is
the
a
by
pharmacologists?
assessment
of
hepatic
volunteers consuming clinical pharmacology, clinical
other
kinds of pharmacology
their
on
that
alcohol just as
clinical
as
in fact,
Another
belief
performed
clinical
multicenter
largely
widespread
was characterized by of useless and placebo-
The of
trial.
Many
pharmacologists research related or physiology,
reputations style
Essence
may
depend
of research.
of
rests
on
point for
Clinical
it.
the first time most people
shopped
some reex-
clini-
acceptable
of my clinical
another
I
activi-
in defining
the
variety
necessity
pharmacology
to
pharmaa step My
great
The
and
called
The last specificity
therapeutic evaluations toxicitics, and cost-benefit and old drugs does define drug
ties
state
a
Pharmacology
sarily so. The study of hepatic oxidases or peripheral and central compartments in man does not define clinical pharmaformance of define utilities, ratios of new
factors over
drugs in which the evaluation was that of subjective effect. (c) A disenchantment with the anecdotal, artful evalua-
and, of
of
‘eloping controlled for a bewildering
carry out to traditional
statedbehaving when
important appearance
(b)
identified
dotal.
three The
nonspecific
around
for
(1967), associated
interest
basis. a
in the
sociology
drugs and,
fers with
to it as that now. mass spectroscopy
When for
no
to it as one re-
However, even equipment
with
that had
of prescrip-
use. No one referred as a matter of fact,
concerned
of
fellowship
I was intrigued with the field
tion that,
often
contention pharmacology
drug
costs,
those were generic
to all. However, other kinds of data are often just a step removed from therapeutics ranging from tablet formulation to
efficacy, the FDA, the secret life of the American pharmaceutical industry, and so on. The concern about the sociology of
cineradiography.
prescription
clinical mandatory necessity positional clinical
Metabolic
pathological for for data discipline
November-December,
data,
data,
good therapeutics, metabolic and did
not under 1975
like
are
often but
drug
bring about discussion.
the disthe
genesis Lasagna cal
drug of clinical once titled
Pharmacologist
Society.”7 akin
in
Clinical this
instance
use
served
as
another
pharmacology. a paper “The as
a
Dr. Clini-
Servant
pharmacology to preventive
of seems mcdi729
MORGAN
cine
and
with but
intervention societal.
community
guidance
The
as
to
the complex drugs-the
what
and
characterize acteristic
and
the of our
To return speakers who
concern
individual, asked for
what
to
of
FDA,
etc.
which clinically oriented teachers medically qualified) teach the
the activity,
I think
important discipline. the the
char-
topic service
seminate pact of
practitioner Clearly our teaching-relates
peers most
the rules learned. The
of
man
the func-
drug inpharmacy human
service-seem characteristic
evaluate,
information drugs on
of
service,
committee to the first to
to of
discuss, relating and
and to
to
the help
choose the best time-consuming to the distribution
intervention
that
of
Clinical
problem
of
pharmacology that all medical
will soon die school deans
to
a part
no
for
a clinical
pharmacologist
ing
and
trend.
probably In
fact,
the
an
revolution
science teaching to basic science
Carr,
Oatcs,
Goldberg nearly
were considered Names such Azarnoff, were
have
all
chairmanships ments; some
730
of these of have
men
clinical
already
pharmaRaisz, Jick,
have
pharmacology accepted and
this been
and
witness shift in
so will
the
clini-
clinical
service
teaching
burden
that
be
clinically
mounted.
as a preclinical
probably
oriented The
days
of
department
numbered.
References
has
At
expand
pharmacology
2. 3.
interest-
Lasagna,
mentioned.
will
basic modified pertains
toward
Their
of
science
that
We will a further
departments
departments.
courses
important
clinical as Gaffncy,
I basic
per se is to be teaching as it
pharmacology cal
proposal Examiners
implies
to clinical intervention.8 in the next few years
principally
occurred, even as we debated our status. When I tried to find out where to go for training in 1967, I learned of a number of men who cologists.
give clearly
in
(usually impact of
imour
The fact the need
is
indicates
longer
examination
least,
departments
will be assumed by clinical pharmacologists, and the position of chairman will be offered to clinical pharmacologists
of
of out. saw
to
very
roles
Pharmacology
definition
changing
pharma-
the
The recent of Medical
1.
The
are
At
dis-
drug. task-
we
amid therapeutics.
drugs on humans. the National Board
are
Future
clinical
they
committee
do:
of
and
briefly to will follow,
investigations me to relate
departments
cology
departments of process of chang-
policy drugs-the
second clinical
therapeutic
to
school in the
of public for new
tions of our units-consultation, formation, drug surveillance, and
ing
Medical are
with
this
be
declined. pharmacology
done
activity
concerns
Our
might
problem search
structure These
health. is not solely society has
and
4.
5.
6.
7.
time, offered
departsome have
8.
Morgan, status Gun. Azarnoff, Clinical ing
J. of
P., and academic
Weintraub, lvi.: clinical pharmacology.
Res. 20:411 (1972). D.: Personal communication, Pharmacology: A Guide to Programs. New York, Pfizer,
The
1971. TrainInc.,
1972. Wolff, F.: The myth of clinical pharmacology. New England J. Med. 280:390 (1969). Fratantoni, J. C.: What is a clinical pharmacologist? New England J. Med. 280: 782 Prichard, cal tion Lasagna, as a
(1969). B. N. C., and Turner, P.: Clinipharmacology: function, orgamizaand training. Lancet 1:653 (1971). L.: The clinical pharmacologist servant of society. Can. Med. Asso. J.
97:109
(1967).
National port 1974.
Board on Goals
The
Journal
of Medical and Priorities.
of
Clinical
Examiners: Philadelphia.
Pharmacology
Re-