Evening star., 1962-09-16
THALIDOMIDE
MonuoI Reveals Plan
To Push Use Of Drug
Continued From Page A


Continued From Page Al
targets and the sales talk pro-
yided for the Merrell employees:
%The program is geared to \
establish, during the next two
months or so, approximately
500 established studies, aver
aging 20 patients per study. |
Your principal sources Of con-
tact viii be in the general
teaching hospital.
I'VE are principally interest
ed IN contracting the most in
fIHential physicians who would
have occasion to use Kevadoa.D
The "Kepadon representa-
tiVes'' we're told to spend full
time establishing studies in
their assigned hospitals and
minimum goals were setse
The objectives of the Job
were listed. They included con-
tacting teaching hospitals and
the chiefs and senior members
Of the departments Of surgery.
medicine. unsatisfactory and
Obstetrics -gSnecology for the
purpose of selling them on Ke-
vadon and providing them with
aciinical supply"
.zOther objectives were ito
eventually accumulate a series
Of clinical reports" and ito per-
feet and develop the best posi-
bic detail story for the national
introduction Of Kevadon."
Under the heading Of "a
word of caution" the 'Keva-
don REPRESENTATIVES," we're told:
Bear in mind that these
are not basic clinical research
studies. we have firmly esta-
biished the safety, dosage and
usefulness Of Kevadon by both
foreign and U. S. laboratory
and clinical studies.
Purpose Outlined
"This program is designed
TO gain widespread cpnfirma-
ton OF It's usefulness in . va
riety Of hosnitalized patients.
If your work Yields case. re-
ports. personal communica-
tons or published work, all
well and good. But the main
purpose Is to establish local
studies whose results will be
spread among hospital staff |
members.
"You can assure your doc
tors that. they need not report |
results If they. don't want to
but that we, naturally. would
ike; to know of their results.
Be sure 70 ten them that we
may send them report forms |
or reminder letters but these |
are strictly reminders and they
need not reply" 4.
THE ''Kevadon representa-
tiges" were told to lay their |
cards on the table. |
sqTell the doctor that present I
plans call for Keyadon to bel
marketed early in 1861. Let
them know the basic elfnicalf
research on Kevadon has been
done. Don't get involved by sell
ing a basic clinical research
program instead Of Kevadon. |
appeal to the Ego" ! "
appeal to the doctors ego
we think he is important
enough to be selected as one of
the first to use Keyador in that
section of the country q. ,lta
The manual pointed out that
the ''Kevadon representatives
must get q qualified investiss-
tor statement z signed by each /
doctor because EDA regulations
specify that before a drug Is
cleared it can be used solely
for investigations "by experts
qualified by scientific training |
and experience to investigate |
the safety of drugs" /. /
The 'sKevadon representa-
tives" were told that if the doc
tors are perplexed BY the
section Of the qualified inyes-
tigator" statement which asks
them to describe their proposed
investigation, they could be told
what to say there. 4
Under the heading Of "im-
portant points to remember
the "Kevadon representatives"
were told: Don't forget that
you are a salesman, a profess
sional salesman"
Prompt Start
The "Kevadon representa-
tiYes" were advised in the man |
uai that their program was to
start Immediately after the Oc-
tober meeting and end at the |
time of Kevadon's national re-
lease unless they were notified
Of a different date. i
The first day of the two-day
meeting for the tKevadon
Hospital Clinical Program"
was October 25, 1860. On the
same day. according to FDA
files now in the hands of the
Humphrey subcommittee, the
drug firm called FDA to find
out which of its, doctors was
handling the Kevadon new
drug application. The doctor
was DR.. Frances o. Kelsey.
n, NJdxay,aha. IN 1OEn dIfr-