MLUrUrtU MAIL IHiauwt;, MfcDrOKO. OREGON
Thalidomide Experience Reveals Need
Editor'! not.: TM. I. ik
lilt of three dispatcher on
i h Thalidomide tragedy.
It ipelli out exiiling gov
ernment rules for regula
. ting new drug product!
end explains new legisla
tive proposals being advo
cated for protection of the
public.
By RONALD H. NESSEN
Washington (UPD Ameri
ca's narrow escape from the
tragic consequences of Thali
domide on newborn infants
paradoxically shows both the
effectiveness of current drug
laws and the need for tight
er restrictions.
Existing regulations, en
forced with dogged determin
ation by Dr. Frances O. Kel
ey of the Food and Drug Ad
ministration, blocked the sale
in this country of the German
developed sedative which has
been blamed for the birth de
formaties of children in Ger
many, England and Canada.
But there were no rules to
prevent the American manu
facturer, W. S. Merrell Co.,
of Cincinnati, from sending
"thalidomide to 1,231 doctors
lor testing on human patients.
There is no rule requiring
that patients be advised
when they are given an ex
perimental drug. There is
no rule requiring that the
government be notified in ad
vance when a manufacturer
distributes medicine for so
called "clinical testing" on
human beings.
Procedures Considered
President Kennedy told his
news conference last week the
government was considering
how to tighten administrative
procedures to make the test
ing of new drugs on humans
less dangerous.
Kennedy also urged Con
gress to approve this year the
legislation he proposed to
toughen safeguards against
dangerous and useless drugs.
The bill is needed, he said,
"to prevent even more serious
disasters" in the future.
No drug may be sold in the
United States unless it is ap
proved by the Food and
POCKET MONEY...
can make for a trunkful of
good times this summer.
Wherever your vacation
takes you, take enough
money. One-visit service.
IQCAL IDAN
535 E. JACKSON BLVD.
MtdforrJ Shoppinc Ctntir
rhone: 773-7456 Dick Webb, Mir.
Opto FrUiy Evanfrifs 'Til 7
With Trade
$17.43 Month
JOHNSTON STORES
Drug Administration.
About three in every 10
drugs submitted to the FDA
are rejected. It takes the agen
cy an average of 62 days to
approve a new drug. How
ever, .-nany cases stretch out
for six months or more and
in some instances the process
takes two or three years.
Tested on Animals
Beiore applying to the
FDA, a manufacturer tests a
new drug on several species
of animals. If no ill effects
show up, the next step is to
try out the compound on hu
mans. This is done by sending the
drug to a selected list of doc
tors who agree to give it to
their patients and report back
the results.
Kennedy, FDA officials and
others feel this is one of the
most dangerous points in the
drug testing process.
Among the new administra
tive moves under considera
tion by the FDA to make this
step safer is stricter policing
of doctors supplied with ex
perimental drugs to make
sure they have adequate test
facilities and submit meaning
ful reports to the manufactur
er. ei i III i iiliJ. ', i.iaTit-gliir .'.i-ta-Jri
WALKS OUT - John Albert
Kerr, 46, whose death sen
tence was commuted by Cali
fornia Gov. Earl Warren in
1953, is shown as he walked
out of San Quentin Prison,
subject to parole supervision
for life. Kerr was convicted
of first degree murder in the
slaying of Troy R. Buckles,
Fresno grocer, in 1950. Kerr
will not be permitted to re
turn to Fresno. (UPD
Soon To Be At The
j Jwi'i'i I
VsS j j Allo"e (
Also said to be under study
are new regulations to re
quire drug makers to notify
the FDA when they start test
ing a new medicine and to in
form the agency immediately
if any injurious side effects
turn up during tests.
Under current procedures,
a drug manufacturer comes
to the FDA only after tests
on animals and humans are
complete and the firm is seek
ing approval to market the
product.
Permission Asked
In September. 1960, the
Merrell Co applied to the
FDA for permission to mar
ket Thalidomide, a drug wide
ly used in Germany and else
where abroad as a sleeping
pill which left no hangover
and was free of the danger of
overdose.
The application was handed
over to Dr. Kelsey, a Cana
dian - born pharmacologist
and physician. It was her first
assignment upon joining the
FDA.
In the face of what she re
calls as Merrell's "very anx
ious" desire to win approval.
Dr. Kelsey was not convinced
by the data the company sub
mitted claiming Thalidomide
was completely safe.
When the 60-day period aft
er which the firm automatic
ally could have marketed the
drug expired, she ordered .an
extension. She did this again
and again with the backing
of her superiors.
In February, 1961, Dr. Kel
sey chanced to read in the
British Medical Journal a
report suggesting that use of
Thalidomide over a long per
iod might lead to a condition
marked by numbness and itch
ing in the hands and feet.
This was the first hint that
the drug might have toxic
effects.
Then, Merrell was notified
from Europe late last Novem
STAR.
By CLAY
yp MAR. 3!
jSS-APIt. 20
. JK, Your Dotty Activity Guide L
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To develop message for Saturday,
t read words corresponding to numbers
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, 17 Friendship
1 8 Seenet
19Good
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21 Smrlrng
22 Peace
23 To
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VIRGO
AUG. 24
SEPT. 2?
30 New
il2-!3-34-46
57-68-88-901
0g)Gooil t) Adverse
Refrigerator
Medford Shopping Center
ber that Thalidomide given to
mothers in the early months
of pregnancy was suspected
of causing phocomelia - a
heretofore rare malady in
which babies are born with
flipper - like arms, missing
limbs and other deformities.
Application Withdrawn
On Nov. 30, 1961, Merrell
notified the FDA of this re
port and withdrew its applica
tion for approval to sell the
drug in the United States.
At the same time, the com
pany contacted the doctors
testing Thalidomide on hu
mans and warned them not
to give it to women of child
bearing age.
Motivation Authority
Joins Medical Staff
Portland - Dr. Judson S.
Brown, nationally recognized
authority on motivation, has
been appointed professor of
medical psychology at the
University of Oregon Medical
school, according to an an
nouncement by Dr. D. W. E.
Baird, dean.
Dr. Brown, formerly gradu
ate research professor in the
psychology department at the
University of Florida, receiv
ed his master's degree from
the University of California
and his doctorate from Yale
university.
Before joining the Universi
ty of Florida staff he was on
the faculty of both Harvard
and Yale universities and the
State University of Iowa.
Dr. Brown, author of the
book, "The Motivation of Be
havior," is a Fellow of the
American Psychological asso
ciation, an honorary life mem
ber of the Midwestern Psy
chological association and a
charter member of the Psy
chonomic society.
GAXElC)
R. POIXAN
LIBRA
EPT.23
4-22-33-445
154-65-80-83VB1
5CORPIO
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OCT. 24 ',
NOV. 22
52-63-82-84
SAGITTARIUS
N0V.23 A.
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9-16-27-38
49-70-78
CAPRICORN
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JAN. 20 VTj$
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Prosperity
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10-21-32-43O
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fisces
MAR. 21 -1fi
11-15-26-3741
48-59-87-89Va
RCA WHIRLPOOL
Automatic Defrost
With Freezer Below
112 SOUTH RIVERSIDE fi
In March, Merrell told the
doctors to stop using the drug
entirely and destroy or re
turn any remaining supplies.
By then it was clear that
Thalidomide had caused
thousands of babies to be born
deformed in Germany, Eng-
Rate Hearings
For Truck Freight
To Be Continued
Salem -0IPIU Another phase
of the hearings to raise truck
freight rates in the state 10
per cent has closed.
Salem hearings on the re
quest of the Pacific Inland
Tariff Bureau wound up Wed
nesday. Hearings, which have
been going on all this month,
resume in Portland Aug. IS.
The proposed rate increase
would include all truck
freight shipments In the
state.
The increase is sought to
offset higher labor costs
brought about by a recent
contract.
It would replace a tempo
rary additional per shipment
charge now in effect pending
the outcome of the present
hearings before a Public Util
ity Commission examiner.
PUC officials said that if
the requested rate increase is
granted it would boost truck
rates above the present tem
porary level.
Most of the witnesses who
have appeared before Hear
ing Examiner Malcolm Jones
so far have been represental
tives of the trucking firms
who have favored the in
creases. . .
Opponents are expected to
be heard at the coming
Portland session.
In addition to the 10 per
cent rate hike the industry
also is seeking to increase
shipments of 20,000 or more
pounds three cents per hun
dred and increase the pres
ent $2.50 minimum shipping
charge to $3.
Oregon Highway
Group Sells Timber
Salem-IUPD-The State High
way commission Thursday
sold for $386,000 timber on
land that it bought for less
than $3,000 in the 1930s.
The timber is located on
three of five tracts bought for
right-of-way and forest way
sides on the Carpenterville
Brookings section of the old
Coast highway.
The high offer in competi
tive bidding came from
Brookings Plywood Co. No of
fers were made on the other
two tracts.
The commission will keep
the land.
TOTAL
CAPACITY
13.8 cu. ft.
FREEZER
HOLDS
163 lbs.
32" wide 65" high
FHIDAY. AUGUST 10, 1962 J
for Tighter Drug Regulations
land and other foreign coun
tries.
The new drug legislation
Kennedy wants congress to
approve would give the gov
ernment control over manu
facturing standards of medi
cine makers. The firms also
would have to prove to the
FDA that new drugs are ef
fective as well as safe.
To accomplish this, the bill
would require new drug ap
plicants to open to govern
ment inspectors all records on
the safety and effectiveness
of a medicine.
Drug names would be stan
dardized, the government
would be given new authority
to police the sale of barbitu
rates and stimulant drugs and
a federal safety stamp would
be required on cosmetics.
Could Order Withdrawal
The government would be
able to order a drug with
drawn from sale if dangerous
side effects showed up after
the FDA had given its ap
proval. At present, the gov
ernment must seek a court
order to halt the marketing of
an approved drug.
) J
CLOSE OUT
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SORRY-WE FORGOT
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SO HERE THEY GO -
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PACKING SUPPLIES
As in the past Western Thrift has a
complete line of quality packers sup
plies at the lowest prices.
A FEW OF THE MANY ITEMS BEING
FEATURED IN OUR COSMETIC
DEPARTMENT AT VERY
SPECIAL PRICES
COUNTESS MARITZA
Summer Colognes O fin
5 POPULAR FRAGRANCES
A $2.50 VALUE FOR
Tussy's Pink Cleansing Cream
PLUS SKIN LOTION OR S")00
SKIN FRESHNER
$3.00 VALUE BOTH a
WiiBlr
Take your youngsters to the
"2 O's" your doctor and
dentist before sending
them back to the "3 R's."
When your children pass pre
school "health exams" they
find it easier to pass their
school exams, because good
health goes hand-in-hand with
steady attendance and good
study habits.
Make appointments with your
doctor and dentist today
they can help your children
avoid going through "School
Daze."
Add Federal Excite Tax
T
I
'tltLV.'.Vi J MEDFORD'S ORIGINAL DISCOUNT STORE
The House Commerce Com
mittee has held four days of
hearings on the measure. A
committee source says more
hearings are planned but no
date has been set. The out
look for the bill is not good.
The Senate Judiciary Com
mittee has written its own
drug bill which Kennedy says
is too weak.
In criticizing this bill, Ken
nedy pointed to the complaints
of Sen. E s t e s Kefauver
(D-Tenn.), whose subcommit
tee conducted lengthy hear
ings on the drug industry.
Kefauver says the commit
THE BIBLE
SPEAKS
TO YOU
Sunday, 9:00 a.m.
K-SHA-860kc
Thii uttk't Chrittian Science irof
"God, Mm and Heaven In th
Spaca Agt"
Sea Siren or Crest
FORMERLY 85c ea.
2,85
tMf lat. 11
on Taxable Merchandise
tee bill, a toned down version
of his own recommendations,
is weak because it lacks these
provisions:
- A requirement that drug
manufacturers meet specific
production standards.
- A requirement that all
drug advertising contain a
"MORE ECONOMY"
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description of any side effects.
- A requirement that a new
drug win positive FDA ap
proval before it can be sold.
This would replace the pres
ent practice of letting a man
ufacturer sell a medicine un
less the FDA raises an objec
tion within a specified period.
f m
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REMEMBER
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XMAS in JULY
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through Aug. 1 1th
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OPEN WEEK DAYS 8 TO 9 SUNDAYS 9 TO 2