JANNUARY 6,1963
THE MICHIGAN DAILY
PAGE THREE
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JANUARY 6,1963 TIlE MICHIGAN DAILY PAGE THREE
lbricht o Get Support
11
....
11
By PRESTON GROVER
Associated Press News Analyst
MOSCOW - Diplomatic sources
suggested yesterday that Soviet'
Premier Nikita S. Khrushchev's
visit to the East German party
congress Jan. 15 is to build up
Communist leader Walter Ulbricht
and not knock him out.
Top - level Soviet delegations
have been sent to every congress
meeting in the East European bloc
this fall and winter. But Khrush-
chev himself will handle the par-
ty representation in the most trou-
bled area in the bloc, East Ger-
many.
East Germany's economy has
been going from bad to worse for
the past few years. Building the
wall through Berlin in August,
1961, was expected to give it a
lift by stopping the flight of top
level workmen to the West. In-
stead, the situation in East Ger-
many has been getting worse.
Ulbricht's End?
There was wide speculation that
the steady deterioration might
mean the end of Ulbricht. But that
is'-not the case either in Moscow
or in certain quarters in Western
Europe.
The announcement of Khrush-
chev's visit came as a considerable
surprise and led to surmises here
that East Germany is in a worse
situation, economically and polit-
ically, than was earlier suspected.
Stalinists
The presence of Khrushchev was
looked upon here as likely to see
the developments of an intensified
East German campaign against
party dissidents, all of whom now
are generally labeled Stalinists.
More talk, but no definite com-
mitments, may arise about settling
the Berlin situation by separate
treaty with East Germany.
Restricted offers of aid might
be given within the limits of the
Soviet Union's own strained pro-
duction system.
Heated Exchange
Another, perhaps more heated
exchange, may occur between the
Chinese and Soviet leaders over
the political and doctrinal leader-
ship in the Communist camp.
Western diplomats feel certain
the Chinese will send a high-level
delegation to East Berlin.
At party congresses in Bulgaria,
Hungary and Czechoslovakia, and
at the congress in Italy, Chinese
delegates attacked the Russian
program of "no-war-with-Amer-
World News
Round
By The Associated Press
NEW DELHI - Prime Minister
Jawaharlal Nehru has informed
Communist China that India is
willing to refer their Himalayan
border dispute to the Internation-
al Court of Justice after Peking
accepts New Delhi's basic truce
demand.
* * *
ca." Soviet spokesmen have since
fought back.
Food, Money
The things most needed by the
hungry East German economy are
food and money. Approaches have
been made to West Germany for
a loan. Help is unlikely to come
in great quantity from the Soviet
Union, where food is already show-
ing spotty shortages, and money is
so scarce that little added capital
can be spent to build up agricul-
ture.
More likely Khrushchev's pres-
ence is intended to warn unwilling
industrial and party workers in
Germany that Ulbricht is still
Khrushchev's man. Besides that,
nobody here can point to a really
promising replacement for U1-
bricht.
Khrushchev and other Soviet
spokesmen have talked recently
about the need of a Berlin settle-
ment, but the line has been soft,
and no deadlines have been set.!
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i
r
J1
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PARTY CONGRESS-Soviet Premier Nikita S. Khrushchev (left)
will travel to the East German party congress, informed sources
predict, to give support to East German Communist leader Walter
Ulbricht.
DRUG INSPECTION:
FDA To Use New Authority
NOW TN PROGR1ES
By W. JOYNES MacFARLAN
Associated Press News Analyst
WASHINGTON-Starting Feb.j
7, the Federal Food and Drug Ad-
ministration will begin checking
on new drugs, with power to bar
those believed either unsafe or in-
effective.
New regulations announced yes-+
terday greatly widen the FDA's
authority to exercise a watchdog
role over experimental use of new
drugs on human beings, before the
medicines are marketed generally.
The added controls over experi-
mental use are the most signifi-
cant of new powers given the
agency under law revisions, voted
by Congress last year. Most revo-
lutionary is the right to terminate
testing when a drug appears to be
unsafe or ineffective.
Thalidomide
Much of the impetus which
brought the law changes and the
resultant new regulations came
from the, international furor creat-
ed by the drug Thalidomide.
"The purpose of these regula-
tions is to eliminate all unneces-
sary risks to the public that may
attend drug development and to
impose only necessary restrictions
on the conduct of investigational
drug research."
Welfare Department spokesmen
said, however, that the modifica-
tions in the proposed regulations
are not believed to have weakened
them.
Necessary Controls
FDA Commissioner George P.
Larrick said the new rules "pro-
vide strong and necessary controls
over the investigational use of new
drugs."
The regulations require that pa-
tient consent to use of investiga-
tional drugs be obtained by investi-
gators, unless this is not feasible
or is contrary to the patient's best
interest.
They will require that the FDA
be put on notice and given full
details about the distribution of
drugs for investigational use.
Clinical investigations be based
on adequate animal studies to as-
sure safety.
Properly Planned
The clinical investigations them-
selves be properly planned and
executed by qualified investigators,
and that these investigators and
the FDA be kept fully informed
during the progress of the inves-
tigations.
"If an investigation finds that
the drug is not safe or is ineffec-
tive, the FDA will require discon-
tinuance," the announcement said.
Previously the regulations did
not require either initial notice to
FDA of a clinical trial of a new
drug or subsequent reports on such
use.
Radioactive new drugs were ex-
empted from the regulations pro-
vided that they are shipped in ac-
cordance with Atomic Energy
Commission regulations.
FDA said the following were five
principal objections to the regu-
lations as originally proposed and
the changes made in response to
them :
1) The proposals were said to be
too inflexible in the planning of
the investigation of the safety and
effectiveness of a new drug.
Animal Study
"The regulations have been re-
vised more adequately to describe
the different phases of the clini-
cal investigation, which may be-
gin only after adequate studies on
animals ...,
2) The proposed regulations
were said to require excessive and
unnecessary record keeping.
"As revised, the regulations call
for 'adequate' records and provide
that only the necessary records
need be kept ...'
Inspection
3) They were said to impinge
upon the physician-patient rela-
tionship, by calling for inspection
of the clinical records.
"The provisions for inspection
of the patient's records have.been
modified, making it clear that the
investigator may withhold the
names of volunteers or patients
unless the records of a particular
volunteer or patient require a more
detailed study of drug effects, or
unless there is reason to believe
that the records do not represent
actual results obtained ..."
4) Sections of the proposed reg-
ulations dealing with publication
of findings of investigators were
construed as restricting free flow
of scientific information.
Promotional Material
"These sections were clarified
to state that the sponsor or per-
sons acting for or on his behalf
shall not disseminate any promo-
tional material representing the
drug to be safe or effective.
(but) . . .this is not intended to
bar factual news reporting to sci-
entists or the public."
5) The proposed regulations
were said to deny extremely im-
portant new drugs ... to patients
who might need them urgently as
a life-saving measure.
"The increased flexibility .
will allow the sponsor of a new
drug investigation to add new in-
vestigators after the program is
started. There is no bar in the
regulations to giving the necessary
instructions to and obtaining the
necessary commitments from a
new investigator by telephone in
case this is needed to save a life."
A spokesman for the Pharma-
ceutical Manufacturers Association
said it is oLvious that the FDA
has tried to meet the basic ob-
jections to the original regulations.
But he added:
"The burden of paperwork im-
posed by the new regulations is
enormous.
"The success of the department
in meeting its stated goals will,
of course, depend in large part on
the wisdom of the administration
of these regulations..."
UNIVERSITY
SHOP
C LOTHING
and
FURNISHINGS
also
WOMEN'S
WASHINGTON - Undersecre-
tary of State George W. Ball will
fly to Paris Wednesday to open
far-ranging talks with NATO on
formation of an Allied nuclear
force for Europe.
NEW YORK-Secretary of La-
bor W. Willard Wirtz said yester-
day the future of collective bar-
gaining is at stake in the 14-day
longshore strike and declined com-
ment on reports that the Kennedy
administration might seek some
legislation making union and
management submit disputes to
compulsory arbitration.
* * *
LONDON-Labor party leader
Hugh Gaitskell was reported show-
ing improvement yesterday, suf-
fering from pleurisy and pericar-
ditis-inflammation of membranes
around the lungs and heart.
* * *
WASNIN&TON - The relay
communications satellite gave evi-
dence yesterday that its power
supply has revived, making two
successful intercontinental test
transmissions, one of them lasting
more than an hour.
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