PRESIDENT AND STRIKE:
AVOIDS RESPONSIBILITY
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VOL. LXXVI, No. 62S ANN ARBOR, MICHIGAN, THURSDAY, AUGUST 4,.1966 SEVEN CENTS
Drug Research Produces Need for Code o]
FOUR PAG
Ethick
By WALLACE IMMEN
Second of two parts
What characterizes ethical be-
b havior in medical experimenta-
tion? Should a doctor have the
privilege of subjecting his patients
to tests of experimental cures
without consulting them? How
may the development and efficacy
of drugs best be controlled?
In spite of this country's ad-
vanced medical technology, these
crucial questions have remained
unanswered for years. Because
there is no consensus as to what
defines proper conduct in experi-
ments on people, until now legal
rulings have been avoided and
solutions left to the discretion of
the individual researcher. Con-
trols were slipshod and temporary.
A tremendous increase in the
volume of experiments involving
new drugs and procedures has
burdened the country's control
agencies and a lack of volunteers
has led many doctors to conduct
tests on patients who are not in-
formed that their therapy is any-
thing more than routine or that
any danger is involved. But often,
much danger is involved, prompt-
ing demands from citizens and
officials for quick action when, all
too frequently, tragic results stem
from such practices.
Doctors, who are chastised as a
group for the actions of a few of
their colleagues, are now especially
aware of the need for reform of
control procedures and a uniform
and adequate code of medical re-
search ethics.,They are also con-
cerned of possible side effects
which could result in prescribing
drugs which doctors, eager to get
their names in medical'journals
and receive marketing approval,
took shortcuts in ;testing.
Seeking quick action not only
on a code, but also on methods of
making drug experimentation safe
and reliable, most activity is being
focused at federal and organiza-
tional agencies as the most effec-
tive means to reach all levels of
research work. Several groups are
working on the same problems, but
there is little cooperation between
them and their overlapping of in-
terests has caused some resent-
m;ent. A look at what is being
done, however, shows that all feel
it is vitally important to attain
accord in medical research pro-
cedures.
Major re-evaluation of both the
methods of approval and in juris-
diction has begun with the Food
and Drug Administration, as the,
highest federal authority chargedl
with the control of development
and marketing of medicines. The
FDA is simplifying procedures to
promote safety and minimize the
need for high-speed testing, the
main cause of questionable prac-
tices in drug experimentation. The
department recently has been bog-
ged down and has begun a pro-
gram aimed at speeding the ap-
proval of new drugs while at the
same time assuring more safety in
the durgs which are already on
the market.
The changes are being directed
by the FDA's new commissioner,
James Goddard. His concern, he
simply states, is "to boost FDA
and medicine in general onto a
higher scientific plane." Since
taking office last January, he has
adopted the belief, "once you've
got all the facts, there's no point
in waiting." He has revamped the
organization and 'reduced the
backlog of work from more than a
year in some cases to a few weeks.
This has been accomplished by
reorganizing the drug supervision
procedures to enable one team of
scientists to follow a pending drug
through all stages to approval,
avoiding much red tape..
Goddard has established "risk
versus benefit" as the most ra-
tional criterion for evaluating the
safety and efficacy of a drug in
the belief that the "risk" involved
in most drugs is small in com-
parison to their potential contri-
bution to medicine. It is a new
approach for the FDA and will
most likely result in the approval
of some prescription drugs which
are potentially more dangerous
than drugs available today, but
much more beneficial in the long
run. In order to make sure this
will work, he has called for an en-
largement of the FDA's clinical
staffs and has established links
with universities and the Public
Health Service for help in assuring
a reputation of scientific excel-
lence for the agency.
Goddard's fight is also for ex-
cellence in the laboratory. It is
his hope that new speed and pre-
cision attained by the FDA will
put an end to the need for sloppy
drug trials and prevent the dan-
gers resulting from haste.
Unfortunately, all the FDA's
work on safety will still come to
little avail if it is bypassed as a
control agency. In this respect, the
doctor is not always to blame as
marketing companies are fre-
quently discovered "neglecting"
certain aspects of drug tests which
may mean a possible re-evaluation
of one of their products by the
FDA.
Paul Lowinger of Wayne State
University Medical School recently
related an incident in which he
was inyolved in a drug toxicity
experiment for a pharmaceutical
house. In submitting his findings,
he requested that the FDA be sent
a copy even though the drug had
already received approval. ,3{e later
learned that his, and many more
reports which contained informa-
tion which may have changed the
statis of some drugs distributed by
the house were never seen by the
FDA. He and others have advocat-
ed a strong new drug law which
requires, among other things, a
duplicate of all drug studies be
sent to the FDA.
An ethics code, however, would
not be in the form of a rigid law
for this would make the medical
clinic a police state. When such
guidelines are established, the
problem of abiding by them v
rest directly on the integrity
individual doctors. The precepts
a code would be drafted and e
forced by the American Medic
Association as the highest autho
ity in the medical profession.
Independence for researche
has been. the call from AMA lea
ers and in the face of FDA e
pansion, they have asked the go
ernment to limit the latitude
its control powers. Outgoing AM
President James Appel highlighl
this belief in his farewell addr
before the House of Delegates cc
vention held in June in Chicag
Appel believes "the FDA unde
estimates the compentency of mo
physicians in drug evaluation a
use." This belief was echoed
incoming president Charles Hu
son who called upon governme
See CONTROVERSY, Page 3
Court Rules
To Dismiss
'Oath' Case
Colorado U Regents
Test Constitutionality
Of State Loyalty Oath
By CAROLE KAPLAN
A case instituted by the regents
of the University of Colorado to
test the constitutionality of the
Colorado loyalty oath was dismiss-
ed in the Boulder District Court
last Thursday.
The Colorado regents are cur-
rently required by law to admin-
ister the oath to all faculty mem-
bers, and several professors have
refused to teach at the school
because they did not care to take
the oath.
The loyalty oath requires that,
all teachers in the state swear al-
legiance to the United States and
* Colorado Constitutions and laws.
and that they promise to teach
respect for the country and flag
"by example and precept" in their
classrooms.
A similar oath was recently de-
clared unconstitutional in Wash-
ington.
According to Frank Bell, news
editor of the Colorado Daily, the
case was dismissed because the
Colorado regents made no claim
for which relief could be granted.
Although there has been no viola-
tion of the law, the regents
thought it might be declared un-
X constitutional, in which case they
would no longer be required to
administer it.
The defendant in the case is
Boulder District Attorney Rex
Scott, since he would be the pros-,
ecutor if a violation of the law
occurred.
The regents and Scott, both em-
ployes of the state government, are
both represented in court cases by
the Colorado attorney general. The
attorney general's office has ap-
pointed two lawyers to handle the
opposing parties' cases.
Bell said yesterday that the next
step, if the regents wish to pursue
the case, is the Colorado Supreme
Court. He said there is some feel-
ing that the district court's deci-
sion to dismiss the case would be
upheld, in which case the regents
would be forced to drop it.
If the decision is reversed, the
district court will decide on the
constitutionality of the loyalty
oath.
The Colorado regents will de-
cide on future action at their next
meeting, Aug. 27, Bell said.
NEWS WIRE
Late World News
By The Associated Press
PARIS-PRESIDENT Charles de Gaulle sent a telegram yes-
terday to Premier Alexei N. Kosygin of the Soviet Union, con-
gratulating him on his re-election and saying it is a "favorable
element" in cooperation between Paris and Moscow.
SAIGON-COMMUNIST dispatches yesterday claimed mem-
bers of the International Control Commission were among those
strafed by American and South Vietnamese planes in alleged
attacks on a Cambodian frontier village.
The commission-composed of Poland, India and Canada-
reportedly was investigating charges of earlier strikes at the
village of Anlong Trach when one raid took place Tuesday, the
Soviet news agency Tass said.
The ICC was formed in 1954 to supervise the truce estab-
lished by the Geneva Conference that year.
* * * *
SAIGON-U.S. B52s STRUCK for a third time yesterday at
the demilitarized zone that separates North and South Viet Nam
and also bombed suspected Viet Cong positions 30 miles north-
west of Saigon.
The U.S. Command announced the eight-jet bombers from
Guam hit North Vietnamese infiltration routes and suspected gun
positions in the six-mile wide buffer zone that divides the two Viet
Nams at the 17th Parallel.
WASHINGTON - PRESIDENT Johnson, speaking at the
swearing-in of a new foreign aid director, said yesterday that
despite its critics "foreign aid has been an important force for
good in the world."
"It has helped build the foundations for peace and stability,"
he said.
Disputing critics who say that foreign aid is endless and in
some cases futile, Johnson said: "We remember that in 1949 some
of our leading news analysts were calling American aid to Japan
a $2 billion failure. One major magazine declared that, 'The
American taxpayer must prepare himself for an indefinite period
of vast appropriations'"
DETROIT - THE NEW CAR market showed surprising
strength last month as sales were the second highest of any
July and ran well ahead of expectations.
Preliminary sales reports from the four U.S. auto companies
reported 635,633 cars sold. This was topped only by last year's
July in which 710,821 cars were sold.
The July just ended had 25 selling days, one less than the
26 of 1965.
The auto industry, which entered July with an inventory of
about 1.7 million new cars, had set its sights on sales of 615,000
cars in July to help with an orderly reduction of the huge stock-
pile.
* * * *
PARTLY BECAUSE THE LEGISLATURE delayed in ap-
proving the budget for higher education, and partly because of
late information about appointments and changes, a number of
University employes were not paid on schedule last Friday.
Most of the delayed paychecks were for academic employes.
-Associated Press
KOSYGIN SPEAKS
SOVIET PREMIER ALEXEI KOSYGIN speaking to the Joint Union Council and Nationalities Council in Moscow yesterday. Kosy-
gin pledged that the Soviet Union will "do everything in its pow 8r to help the Vietnamese people expel the Americans."
'66 Election
May Prove
Good for 'U
Voters Oust Thorne,
FlaVin--Newcomers
May Be Less Critical
By MARK LEVIN
Special To The Daily
DETROIT - Michigan vote
turned 12 state legislators out
office in Tuesday's primary ele
tion,. and Lansing sources indic
that two of these defeats may hc
promise for improved Universit
Legislature relations.
Reps. Harry Thorne (D-Detroi
and Raymond Flavin (D-Flin
were both defeated by challenge
from within the Democratic par
Both were members of the pow
ful Ways and Means Committi
which acts as the appropriatio
committee, f o r t h e Miehig~
House.
Thorne, a member of the Joi
Capital Outlay Subcommittee, b
been one of the outspoken criti
of the University for its failure
comply with P.A. 124. Under t
provisions of this act, the Jo
Capital Outlay Subcommittee h
the power of dispensing planni
money for higher education c
struction.
Leaves Vacancy ;,
Thorne, a Lansing obser
commented yesterday, was "intE
upon the assertion of legislat
power in the field of higher ed
cation." His defeat leaves a 1
cancy on this important subco
mittee, which could be filled b3
House member more favorable
the University.
Flavin, a freshman legislat
sided with the State Board
Education in favor of an in
pendent Flint college in place
the present Flint branch of I
University.
He was also a strong advocate
state support for the propo
Osteopathic College, which n
with criticism from some univ
sity observers.
Dzendzel Wins
Another Democrat, R a y m 0:
Dzendzel, majority leader of I
Senate, narrowly escaped def
from a strong challenge by JC
Lama, a Wayne 'State Univer
speech instructor. Dzendzel si
ported the Communist speal
ban at state universities, and
opponent was strongly backed
the Wayne State University Yot
Democrats and other liberal e
ments in Dzendzel's district.
The AFL-CIO, however, g
their endorsement to Dzend
which helped him in the r
Dzendzel, who also introduced*
stop-and-frisk bill into the S
ate, had strong backing f1
homeowners' groups and ot
conservative groups within
district.
Jack Faxon (D-Detrot), cha
man of the Subcommittee
Higher Education Appropratic
received the largest number
votes of any state legislator in I
troit. He had four primaryi
ponents.
Faxon, considered the , c
critic of University tuition
creases, has accused the Univ
sity of taking insufficient intem
in student welfare. He cond te
recent inquiry into tuition rai
In a local race for the Repl
can nomination to U.S. Congr
as well as three Republican st
congressional contests, moder
Republicans defeated their 'c
servative opponents. They
EDUCATION:
More Power, Responsibilities Lead
To Rapid Expansion of SE Staff
By PATRICIA O'DONOHUE
The State Department of Edu-
cation (SDE) is in an "unpreced-
ented period of growth," accord-
ing to Marvin Tableman, special
assistant to Ira Polley, Superin-
tendent of Public Instruction. As
a result it is rapidly expanding the
size of its staff.
Tableman explained that this
expansion is necessary because un-
der the new constitution "this of-
fice has received new and broader
powers" and as a result, more re-
sponsibility. He added that the
new federal programs enacted
during the last and present ses-
sions of Congress and the Execu-
tive Organization Act have neces-
sitated a re-organization of the
department.
Tableman said that the SDE
was also responsible for the regu-
lation of state school programs
and supervision of the new scho-
larships awarded to the tuition
grants for private colleges.
He added that the SDE has in-
creased the size of its staff by 33
per cent in the last year. He indi-
cated that this figure would be
doubled within the next three
years.
Demand Consultants
He explained that present'-serv-
ices of SDE, such as the Vocational
Rehabilitation Program, the ele-
mentary and secondary school re-
ports, and the Report on Higher
Education demand many consul-
tants and professionals in the
field of education. He said that
'Phantom'
Drop-Outs Missing from
Records;
"the competition with the profes-
sions" hindered these acquisitions
but that they were gradually in-
creasing the staff to the number
which they feel is needed.
At the present time SDE is in
the process of developing the re-
port on higher education. Dr. Har-
old Smith of Upjohn in Kalama-
zoo is currently heading the com-
mittee preparing that report.
Tableman said that the report.
will establish guidelines for the
planning and coordination of
higher education in the future
and will include planning, pro-
gramming, budgeting and facili-
ties planning for state' institutions
of higher education. He said the
report should establish prelimin-
ary guidelines within 8-10 months.
Charles E. Morton, a member of
the State Board of Education,
said that the aim of the report on
planning coordination between the
institutions of higher education is
to tie these schools into a state-
wide 'system. He Added that this
would not interfere with existing
programs.
Lack of Funds
Morton cited the lack of funds
as a big problem in providing the
kind of staff the SDE needs. He
added that the low pay and civil
service classification prevented the
department from obtaining many
nationally prominent people who
are earning more in other states.
Morton said that the plight of
Flunk-Out Percentage Higher
Than Estimates
By MEREDITH EIKER
Students withdrawing from the
University during the academic
year can often not be identified
by University records. According
to Robert Cope, Grad, University
records can only be used to ident-
ify "students who voluntarily left
and went through the normal
withdrawal procedures and stu-
dents who were asked to leave be-
cause of disciplinary action or aca-
demic failure."
counted for by the record system.
Cope explained that the main
purpose of the research being done
as part of the Michigan Student
Survey is "to gain a more thorough
understanding of why students
leave the college they first enter
as freshmen and to assess the
nature and extent of undergradu-
ate problems in a large university."
Students not enrolled at the
University in the fall semester of
1965 who were originally enrolled
Data on the entering freshmen
of those two years was obtained
from normal University records in
the Office of Admissions and from
the extensive collection of data
gathered in the .Michigan Student
Study. 2207 students were admit-
ted to the literary college in the
fall of 1962 and 2161 students in
the fall of 1963.
Of the total 4368 students en-
tering the University's literary
college in those years, 1387 stu-
dents appeared on the compara-
Questionnaires revealed that the
most common reason for with-
drawing from the University was
"academic failure." Dean William
Haber of the literary college ear-
lier this summer noted that only
about five per cent of the students
in the college are asked to leave
for academic reasons. Edward G.
Groesbeck, University registrar,
said that the overall flunk-out
rate at the University is about
eight per cent.
,,_ V% _ -h - aV1" fail t at.e -
demic failure because the Univer-
sity only identifies those whom it
actually asks to withdraw as hav-
ing flunked out. Students who
withdraw because they feel they
have failed academically are not
included among University failure
percentages.
Groesbeck commented that the
University has not wanted to go to
the expense of keeping detailed
student withdrawal data. Studies
by individual offices such as the
one the Michigan Student Study
withdrawal such as needing higher
grades in order to be admitted to
graduate school and wanting to
major in a field not offered at the
University. Cope said further that
many students who leave the Uni-
versity go directly into medical
schools or other professional
schools and cannot be considered
drop-outs from higher education.
Data Cope is collecting also in-
dicates that female withdrawal is
somewhat greater than male. This
he attributes to marriage and