davidaulloa/AmericanStories huggingface dataset:
Evening star., 1962-09-09

several years ago in his first
correspondence with drug COM
panies. @
He estimated that eight OF
his articles have been published
over the past two years and In
dicated that way why the drug
firms had contacted him.
A good deal of the work, he
said. was handled by his nurse
who took blood pressures, meas
ured weights and made notes
on the case history forms he
submitted to the drug COM
panies.
He said each test took three
or four months to complete
sometimes longer. Sometimes
he said. he requested a grant tc
finance the work.
Most of the drugs he tested
he said, worked out pretty well
and he added: eff the result:
are favorable, it helps the
sales"
He was asked If he had the
records for all the tests he had
made, particularly since he ha6
said he often identified the
patients used in the test only
by initials or numbers. He said
he kept the records and the
code to identify the patients fol
at least six months after re-
porting his findings to the drug
company and then he destroyed
the records. He said he de-
stroyed the records because I'll
invades the doctor-patient re-
lationship."
Comments on Allegations
When he was asked to COM
ment on allegations that he
had reported testing more pa
tients than he had actually
seen, he replied:
That's definitely not true,
Every patient I put down I saw
myself or my nurse treated
not treated-took blood pres
sure"
The Senate-passed legisla-
tion clears the way for regu-
lations. This would make sure
that the reports on clinical
testing enable the Food and
Drug Administration to make
an accurate evaluation of the
safety and effectiveness of
drugs before they go on the
market.
The legislation also. specifi-
cally refers to adequate and
well controlled Investigations
/. :. by experts qualified by SCI
entific training and experience
to evaluate the effectiveness Of
the drug involved !"
Purpose Of Rules Told
The proposed regulations on
which all shades Of opinion
have been invited were drawn,
said Secretary Celebrezze, with
the purpose clearly in mind of
imposing no .unneeded restric-
Evening star., 1962-09-09

society about Doctor z but did
not and somehow got the i'm
preston that Doctor 2 had
served a residency. which he
hadn't. Doctor 2 was approved
by the firm and turned in find
ings which the firm considered
'too good" The drug had been
used previously in Europe, so
Doctor z had an idea what the
drug should do. He wrote a
paper for a medical journal but
it was rejected.
1 An antibiOtic-Doctor z ap-
preached the drug firm and
Offered to study a drug already
on the market. If any check
was made on him. the drug
firm didn't mention it. The
firm spokesman said when
doctors ask to study q drug
already on the market the firm
is inclined to agree to the study
in order to pick up rare side
effects that might not have
shown up in the previous clin-
ical investigation. Doctor z
wrote q paper on this drug
which was published. He re-
ported testing the drug on 73
office patients suffering from
things from pneumonia to post
Surgical infection. He reported
excellent results in 81 cases,
good results in six cases and no
side effects.
A drug to control coughing
A drug to control nausea and
vOmiting-Doctor z was sug-
gested for testing by someone
in the Washington area, pos
sibly one of the firms sales
representatives. He was con-
sidered IAN opinion molder"
because of the articles he had
published in medical journals.
The drug was already on the
market and he was approved
for testing Of it to determine
safety for over-the-coumter
use. Since 1t is difficult to
find doctors willing to take the
time for clinical investigation,
the firm is inclined to go
along with an investigator un-
til some question turns up.
The firm acknowledges there
has been slipshod investigation
of investigators. On this drug,
Doctor 2 published an article
calling it "a safe and remark
ably effective drug for the
treatment of nausea and vora-
iting from a variety of causes. .
The only side effect he re-
ported was a slight drowsi-
ness in IA Of the 101 patients
he tested. Nevertheless, the
firm withdrew its application
for over-the-counter distribu-
ton. Even before the FDA
inspector visited the firm, Doc
tor z had been put on the
Evening star., 1962-09-09

studies included in the new
drug application. There, he
found the report Of Doctor z.
From the number Of children
with diarrhea reported in Doc
tor rs study, the FDA doctor
got the impression he was
looking at the work Of an ex-
tremely busy pediatrician. He
found instead the young gen.
eral practitioner.
He found that Doctor 2 had
submitted a paper on the diar-
rhea drug to a medical journal
which had accepted but not
yet printed 1t. In the paper,
Doctor z reported only minor
side effects in 4 per cent of
the children who received the
drug and concluded that the
drug was effective and gen.
orally tolerated at a dos
age which the FDA doctor was
convinced would have caused
serious effects in infants.
All Tests Investigated
On the basis of the FDA doc
tors findings. an FDA investi-
CATION Of all Doctor rs tests
was launched.
Going over some Of the same
ground, The Star questioned
some Of the drug firms for
whom Doctor 2 had worked.
In every case checked, Doctor
2 had been given a grant to
finance the test. This varied
from $40 to SIS per patient
tested and averaged out to ap-
proximately $4,000 a test.
All the drug firms checked
we're asked the same basic
questions: How did Doctor 2
come to test for you? What
checks did you make on his
qualifications? What kind of
reports did he make? Here
are some Of their answers:
The controversial diarrhea
drug-Doctor 2 indicated he
was interested in working on
the drug. Two Of the firms
physicians visited his office and
checked on his facilities. In
their opinion. he had sufficient
practice to collect the data,
After he began testing, the data
he reported looked bona fide,
It checked fairly closely with
that Of another clinical tester,
whose work had been supplied
to him.
A drug for diseases Of the
artery-Doctor z wrote the
drug firm to say he wanted tc
do clinical testing and had the
facilities for it. A regional re-
search manager for the firm
went over his patient list. The
firm was later convinced that
this check on Doctor 2 was in
adequate. The research manager
who did the checking was sup
posed to ask the local medical
Evening star., 1962-09-09
China Aids
Refugee Flow
Into Macao
From Portuguese
Colony Traffic
Goes TO Hong Kong
By RONNIE WEI
Associated Press staff Writer

MACAO, Sept. Bred Chins
has q finger In practically every
pie in this sleepy little Portu-
guese colony off the Chins
coast.
It even takes q cut on the
illegal refugee traffic between
Macao and the neighboring
British colony Of Hong Kong
Officially Peiping has MOTH
ing to do with the smuggling
of refugees from Macao to
Hong Kong.
But the way the system works
is an open secret. Several
smugglers explained it to an
Associated Press Correspondent.
Many Of the smugglers are
associated with established
travel agencies in Macao. Some
of them operate as independ-
ent agents themselves.
Registered In Canton
The most successful agents
are registered with an official
travel agency in Canton, across
the border in Communist
China.
This agency works with the
security section of the Canton
police department. which issues
exit visas permitting Chinese
to leave Red China.
Up until this year, exit per-
mits were rarely issued and
then only to the sick and aged.
Since January /, however, more
than 10000 visas have been
issued as part of a new policy
apparently aimed at relieving
the pressure on inadequate food
supplies, and to remove NAL
contents. -.
Macao has no restrictions on
immigration from China. Many
Chinese leaving China, how
ever, have no entry visas for
Hong Kong or any other for
eigh point beyond Macao.
Booked Onward"
"The official travel agency
in Canton usually recommends
a specific travel agency in
Macao for what is described
as onward bookings beyond
Macao" one Of the smugglers
said.
These recommended travel
agencies. in Macao are re-
quired to maintain q deposit
of $1,000 with the Canton
agency which charges IS for
each refugee recommended to
a Macao agency"
Onward bookings" usually
to Hong Kong. are arranged
by Macao agencies which have
more than so motorized fish
ing junks.
Fares, based on sex, age, and
dialect spoken. range from $50
to 5000, These are collected
Evening star., 1962-09-09

United Nations lifeline to the
interior, the reality Of the q. N.
presence in the Congo behind
all the abstract politics and
high-leyel palaver.
Assembly Doesn't Matter
/ Deliberations Of the General
Assembly don't matter here
what matters is that U. N. ex-
perts are on hand to operate
basic public services for the or
dinary people.
Villagers and missionaries
from miles around converged
at the grass landing strip. smil-
ing and waving as soon as they
heard the CATS motors.
The doctor brought 500
pounds Of medicine and sup
plies for emergency operations
only the night before twins
had been born in town by
CaeSarian operation under a
fading gas lamp.
A breathless American mis-
sionary of "a years work in
the Congo recognized the
American accent of a reporter
among the new visitors. She
pushed through the crowd to
embrace him gustily.
This man is from my vii
lage," she cried in Swahih to
the delighted mob Of children
around her so they could join
in her excitement.
The missionary. Miss Helen
Hoffman, was from Pittsburgh
and the journalist came from
Tucson, Ariz., but from the re-
moteness Of Shabunda Just
about anywhere in the United
States is the same village.
Supplying 500 Teachers
Every day somewhere in the
Congo this experience is re-
peated. as tough military and
civilian pilots fly their q. N.
missions into areas untouched
by any government or central
administration.
It's part of U. N. civilian
operations, the vital task Of
keeping everyday life going.
In a vast nation the size Of
all Western Europe the U. N.
effort sometimes seems merely
to scratch the surface, but
without it there would be next
to nothing.
The U. NJ. Is supplying 500
secondary school teachers and
transporting returning Belgian
teachers to bush schools.
Agriculture experts are flown
in to restore rundown farms
and get the food supplies back
up to pre-independence level.
In Kivu late last year the cot
ton crop nearly failed simply
because the banks had no hard
cash to advance to prospective
buyers. The U. N. flew in mill
lions Of Congolese francs to tide
the area over the breakdown in
national banking facilities.
Thirty tons of automobile
spare parts have been flown
into Oriental Province to restore
road transport. The Kivu fruit
and vegetable crop last year
rotted at the farms because
there were no trucks available
in working order to take 1t to
. market.
To supervise the civilian op-
erations, the U. N. has an In
ternational team of 454 tech.
nicians from ~ countries,
Largest contingents are from
France. Haiti. Spain and Italy,
Evening star., 1962-09-09

from friends or relatives In
Hong Kong. The refugees them
selves can take out of China
only the equivalent Of $l.40 II
they are heading for Hong
Kong or II cents If they are
stopping at Macao.
Have "COde Of Morality"
Macao smugglers have their
own "code of morality"
They collect fares only after
the refugees have safely landed
and made contact with relatives
or friends in Hong Kong.
If a refugee trying to enter
Hong Kong illegally is inter-
cepted by British authorities
and deported to Macao after
serving q Jail sentence, tn e
Macao smugglers consider
themselves obliged to smuggle
him to the British colony again
free Of charge.
Just how much the Chinese
Communists have collected
from the Macao smugglers is
anybody's guess.
Social welfare workers say
most Of the $4,000 refugees
from Red China who reached
this Portuguese colony this
year with Communist exit per-
mitS have gone on to prosper
Gus Hong Kong through the
recommendation Of the Canton
travel agency.
Packed Below Decks
The usually quiet Macao
waterfront is dotted with
agencies. Some serve as hostels
for refugees. They even pro-
vide recreation In the form of
mahjong games. The refugees
are permitted to settle their
lnahjong debts after they reach
Hong Kong, where Jobs are
comparatively easy to find.
Every night at Black Sand
Evening star., 1962-09-09

seldom far away. His helicop-
ter or car may appear unex-
pectedly anywhere in the coun-
tryside. Peasants emerge from
the fields and their picturesque
homes atop stilts for q chat
with the Prince.
He may only inquire about
crops or local problems. Or he
may deliver a high-pitched i'm
promptu policy address lasting
several hours.
Speaks With CandOr
His candor with his subjects,
whom he always addresses as
my children" extends even to
his family. He has warned
Camodian families again st
the wayward habits of one of
his sons with a well-known eye
for the ladies.
When Prince Sihanouk cap
tains the palace volleyball, Soc
Ger or basketball teams in a
match, the public is always in
vited. Sometimes his team even
loses. Afterward. he often holds
impromptu public press con-
ferences. buffet suppers and
dances.
But possibly Prince Shan
ouk's favorite sport is discom-
fitting the great powers, know
ing that much Of his country's &
influence depends on his play
ing East against West. The
powers put UP with it because
Of what might be gained.
A Cambodian tip to the West
could create a solid anti
Communist belt across the
southern end OF Indo- China. A
tip to the Communists might
split Indo-C China down the mid
die and put Red Chinese troops
on the borders Of pro-Westerr
Thailand and South Wet Nam
Prince Sihanouk has threat
ened to call in the Communist
Chinese unless the West agrees
to his latest proposal. He wants
an 11-nation conference along
the lines of the Geneva con-
ference on Laos which woulc
guarantee Cambodian neu.
trality.
The Communists quickly In
dorsed the proposal. The
! United States is hesitant, how
ever, because such q confer.
ence would be aimed primarily
at Thailand and South Viet
Nam.
Evening star., 1962-09-09

firms restricted list" The
reason was not given.
Doctor 2 wrote the firm a let
ter offering his services for
certain types of tests. He was
called on twice by representa-
tives Of the firms medical de.
partment. The drug did not
involve a new-drug application.
His report sounded so good
that the firm got a little sus-
picious. Overall. 81 per cent
of those tested, he reported,
had excellent results from the
drug and the remaining pa
tients had good results. His
findings were published in q
medical journal. Although he
asked to make more investiga-
tions for the company, it was
decided not to use him again.
The drug firms were not the
only ones who got Jerry about
his enthusiastic reports. One of
journals rejected an article on
an antihistamine for allergies
after it was shown to a spe-
cialist in the field.
The specialist said that, diff
ferent persons. with different
conditions vary tremendously
in their response to antihis-
tamines. According to Doctor
z, the specialist said, "all the
conditions respond equally well
and this ] doubt"
Early Tests Cited
The drug firms checked by
The Star emphasized that in
the early stages Of an inves-
tigation. only well-known clin-
ical investigators usually con-
nected with a teaching hospital
do the testing. They said they
used general practitioner later
to see how the drug would work
when it went into doctors Of
fics and was under less care
fully controlled circumstances.
All Of them denied what was
charged at the time FDA re-
ported that thalidomide had
been sent to more than 1900
doctors-that the clinical test
ing on this scale was to create
a demand for the product be-
fore FDA cleared it for safety.
Doctor z told The Star he
was approached by the drug
firms to do their testing. He
estimated that he did at least
five or six Q year but added that
he was not doing it any more
because he had changed offices
and lacked the room to store
all the drug samples. Besides,
he said, he was now too busy.
Doctor Cites Articles
He said he sees between 80
and 40 patients a day and his
usual test encompasses about
100 patients. He used the same
Evening star., 1962-09-09
DATELINE BEIRUT
New Storm Due
In Arab World
By WEBB MCKINLEY
Associated Pres StaH Writer

BEIRUT. Lebanon, Sept. 8
"A new storm is building UT
among Arabs in the Middle
East.
At its most violent, it coulc
topple governments and cause
bloodshed. Or it could turn out
to be merely another epic vino
of words and gestures.
The outcome win depend
mainly on Canal Abdel Nassei
and the influence he can exert
on the Arab masses.
Egypt's walkout from the
Arab League meeting ir
Shtaura, Lebanon. was a storm
warning. Mr.. Nasser is droppine
any pretense Of dealing with
other Arab governments in the
leagues polite channels. He /,
taking off the gloves and COINS
to work more than ever directly
with the people-if necessary
against their governments.
Never on Defensive
It's an axiom that Mr.. Mas
ser never goes on the defensive
Syria's successful breakaway
from his United Arab Repub.
lie one year ago hurt him but
did not cost him his popularity
with the Arab man Of the
street. He reacted by intensity.
ing his drive for a kind o.
national socialism in Egypt and
by abandoning the facade o.
friendship with what he con.
siders the Arab worlds reac.
tionary regimes.
In the past year, Cairo has
broken with. medieval Yemens
ruling Imam, gone all-out ir
nftn1 eau fas an -
Evening star., 1962-09-09

Manufacturers Association has
already informed Secretary Gel
ebrezze that its member firms
generally are in sympathy with
the objectives Of the proposed
regulations on clinical testing.
An a association n spokesman,
however, left the door open to
question the details of the reg
ulations on reporting require
ments after clinical studies get
under way on new drugs.
The case of Doctor z Illus
trates why both the legislators
closest to the current drug in
vestigations and FDA want to
make sure that the men whose
tests are vital in clearing the
way for a drug to go on the
market are qualified by train
ing and experience to do the
job.
Denied by Doctor
Doctor z denied to The Star
that he ever made up his find
ings. He denied that he ever
reported the results of tests that
he didn't actually make. He
also denied that he ever ap-
preached the drug firms to let
him make tests for them. And
he denied that he was aware
FDA was. interested in his re-
ports to the drug firms.
Outside Of confirming that
an investigation was in prog
ress-a fact known to at least
a dozen drug companies-FDA
declined comment on Doctor z.
From other sources. including
the drug firms which have CO.
operated with FDA in the In
vestigation. The Star pieced
together this story of Doctor z:
A drug for diarrhea in chill
dren had been approved by the
FDA and was on the market
when the manufacturer was
informed that two infants in
New Jersey had suffered vio-
lent reactions to the drug.
The company proposed to
change its labelling to warn
that the drug should not be
given to children who were
dehydrated. but an FDA doctor
insisted that the drug itself
had caused the dehydration.
FDA Urges Warning
FDA proposed that the warn
ing should caution against
giving the drug to infants but
the company insisted the drug
was not dangerous. Finally,
FDA made several seizures OF
the drug on the ground that
letters to doctors promoted the
drug for more severe pediatric
disorders than were approved
in the labelling cleared by FDA
While an FDA doctor was
checking on the drug, he went
back to study the clinical
Evening star., 1962-09-09

stranded in trees and bushes
that had been submerged.
Lake Restricts Floods
The Mekong River floods that
often ravage neighboring Wet
Nam scarcely touch Cambodia,
thanks to the two-way Tonle
Sap River. AS the Mekong
swells, most Of the overflow is
taken up by the Tonle Sap and
fed into the Great Lake. a nat
ural reservoir. AS the Mekong
recedes, the lake discharges
back into the Mekon via the
Tonle Sap and lake fish may
be harvested with pitchforks.
Communism and anti-com-
munism have little meaning
for the Cambodian peasant. A
United States official in Phnom
PENN recently hired q CAM
bodian servant whose last Job
had been with @ Communist
embassy. The servant was sur
prised when the American fam
lily did not observe q Commu-
mist holiday.
IT thought all Westerners
we're Communists" he said.
well, 1t doesn't matter"
The Cambodian peasant is
content to fish and farm and
leave the politicking to Prince
Sihanouk. their beloved and
virtually unchallenged chief of
state. With some foreign as
sistance, he has brought his
country real advances in econ
omy. education and health
standards.
Prince Is Popular
Prince Sihanouk,s personal
ity is as full of surprises as
his country. One of several
princes, he was chosen King
in the wartime l94Os by agree
ment of the occupying Japanese,
Buddhist monks of two major
denominations and the help
less French colonials; in the
postwar period Prince Shan
ouk abdicated to make his
father king, and since hi:
fathers death he has chosen
to be simply Prince and CHIEF
Of state. He plans piano ant
saxophone. likes Debussy, anC
composed "Cambodian Suite,
a work. played by Maestro
Leonard Bernstein's New YorH
Philharmonic Orchestra on Q
world tour.
Prince Sihanouk's5 popularity
is almost absolute. And, he Il
Evening star., 1962-09-09
Doctor Cites Articles

He said he sees between 80
and 40 patients a day and his
usual test encompasses about
100 patients. He used the same
figure Of 80 to 40 patients day
Evening star., 1962-09-09
Purpose Of Rules Told

The proposed regulations on
which all shades Of opinion
have been invited were drawn,
said Secretary Celebrezze, with
the purpose clearly in mind of
imposing no .unneeded restric-
Evening star. [volume] (Washington, D.C.) 1854-1972, 1962-02-05

New York City and was a
consultant for the Borden Co.
A spokesman for M. I. T. said
the two couples had been in
Peru for several weeks doing
nutrition search and were due
back in about a week.
Farmers living near the crash
scene said they heard two ex-
plosions at the time. Some
farmers said the plane may
have been struck by lightning.
Fire swept through the plane,
and bodies of the victims-15
passengers and 3 crew men,
bers-were badly burned.
DR.. Uham was employed as
a biolchemist at the Food and
Drug Administration here in
Washington from 1855 to 1858,
when he went to the division of
research grants of the National
Institutes of Health, Bethesda.
He mad been a research fell
low at Harvard University,
where he got doctor of science
degree and was selected to at
tend the International Congress
of Nutrition in Paris.
He and his family lived at
2542B Holman avenue, Silver
Spring, when he was employed
at NH.
Evening star. [volume] (Washington, D.C.) 1854-1972, 1962-02-05
Berlin Guards
Toss Tear Gas

BERLIN, Feb. S (AP).-A
tear gas grenade battle erupted
across the Berlin wall yesterday
in the most serious incident of
its kind since before Christmas.
The fight occurred after
East German border guards
tossed grenades twice at Sun
day strollers on the West side
of the wall who had waved to
persons on the East side.
The second time this hap
pened, 30 Eastern grenades
were answered by Is grenades
from West Berlin police. When
one Of the Western grenades
hit an Eastern policeman on
the thigh, a comrade fired four
shots from his tommy gun. But
nobody was hit.
Conditions along the wall
had been relatively quiet for
the last six weeks.
A cold but dry day encour-
aged strolls. West Berliners
were joined in the promenades
by visitors from West Germany
in town for an annual farm
fair.