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-

Academic clinical pharmacology: development, current and future status.

Academic Clinical Pharmacology: Development, Current and Future Status JOHN DURING 1971 and Weintraub questionnaires of clinical and 1972, ph...
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