THUHSDAY, AUGUST 30, 1962
MEDFORD MAIL TRIBUNE. MEDFORD, OREGON
MEDFORD MAIL TRIBUNE. MEDFORD. OREGON
THURSDAY. AUGUST 30. 1362
ispatch Tells Why Administration Wants Jef Drug Legislation German
FHitnr'. Not: Stirred by
1 h thalidomide tragedy.
Congress it talcing a close
look at America'! drug con
trol lawi. Preiident Ken
nedy ayi new legiilation ii
needed to protect the public
from "unsafe and worthies!
drug products." Pharma
ceutical manufacturers
warn that "unnecessarily
extreme" controls may de
lay introduction of life
saving medications. The fol
lowing dispatch tells why
the administration thinks
specific proposals now in
Congress are necessary and
why, in soma instances, the
drug industry is opposed to
them.
By LOUIS CASSELS
Washington - - Amer
ica has the strictest drug con
trol laws of any nation on
earth.
But the agency which en
forces these laws, the U.S.
Food & Drug Administration
(FDA), has been warning for
years that they are strict only
by comparison with the rel
atively lax requirements of
other countries. It has said
repeatedly there are danger
ous loopholes which ought to
be plugged.
The FDA's pleas for new
legislation have met with con
siderable resistance from the
$3.5 billion pharmaceutical
industry, which contends that
too much government regula
tion will do more harm than
good by stifling progress in
drug development.
The drug manufacturers
seemed to be winning the
argument, so fBr as Congress
was concerned, until the re
cent thalidomide scare. This
country's close call with the
baby-deforming drug put
Congress in the mood to pass
a bill. Legislative proposals
which President Kennedy
made on behalf of the FDA
last March have been re
trieved from committee
pigeonholes in the House and
Senate. Early action seems
likely. .
The major administration
proposals around which con
gressional debate will center
are:
LICENSING NEW DRUGS
Under present law, a new
drug may- to placed on (he
market 60 days after the
manufacturer has submitted
a licensing application unless
the FDA intervenes to block
it.
If the FDA is dubious about
a new drug, but lacks evi
dence to supress it outright,
it may stall for months or
years by demanding further
information or raising succes
sive objections to the details
of the application. That's how
FDA mcriicul officer Frances
O. Kclscy spared Americans
from a thalidomide disaster.
But as the law Is now worded,
FDA scientists feel they are
under pressure to let a drug
go on the market unless they
can demonstrate it's unsafe.
Under the proposed legis
lation, the "affirmative ap
proval" of the FDA would be
required before any new drug
could be marketed. If the
FDA failed to clear an ap
plication within a reasonable
time, the manufacturer could
demand a hearing. But the
burden of proving the drug
safe would clearly rest upon
the manufacturer.
Drug manufacturers con
tend the FDA already has
adequate powers to require
complete proof of a drug's
safety before letting It reach
the market. They say animal
tests, clinical trials and other
evidence demanded hy FDA
In a new drug application
often fill a six-foot sheld of
' volumes. The new procedures,
they say. would permit
bureaucratic inertia to delay
the introduction of valuable
new medicines.
EFFECTIVENESS OF
NEW DRUGS
Present law does not re
quire a manufacturer to prove
a new drug is effective as well
as safe. Even if the FDA has
a good reason to doubt the
efficacy of a product, it has
no choice but to let it. go on
the market. Once it Is on sale,
the FDA can seize It as a "mis
branded" drug, but It must
be prepared to offer proof In
court that the drug won't do
what the manufacturer has
claimed for it.
John L. Harvey, deputy
commissioner of the FDA, re
fers to this procedure as a
"cat-and-mouse game which
allows a manufacturer to fool
the public with a worthless
product until the government
catches up with him." '
The new legislation would
put the shoe on the other foot.
The manufacturer would be
required to prove his product
is efjective, as well as safe,
before it is lirensed for com
mercial sale
The Pharmaceutical Manu
facturers association cI'MAt.
which represents leading eth
ical dnm houses, agreed "in
principle" with this proposal.
Bui it is anxious to have the
law so worded that "substan
tial evidence" of a drug's ef
fectiveness will be enough to
let it be placed in tne nanas 01
ohvsicians for trial. The ad
ministration's bill calls for
"preponderant evidence and
(ho Hrn0 manufacturers fear
that this language could block
drugs whose ctficacy is ques
tioned by some authorities,
though others may consider
them 01 tremendous nie-sav-ing
value.
REPORTS ON EXPERIENCE
WITH NEW DHUUS
In 10R1 Ihp Fn A learned
belatedly that a muscle-relax
ing drug, which had been on
the market since 1956, had
been implicated in 54 cases of
DISTRESS CALL
New York - Before thr let
lers SOS were generally
adopted as a distress signal,
the letters CQD were often
jmd.
hpnatitis. including 15 deaths.
After recalling the drug from
the market, it discovered that
the manufacturer had been
accumulating reports of these
adverse reactions for five
years without saying anything
about them.
The new legislation would
require drug companies to
make regular reports to the
FDA on clinical experience
with the new drugs.
WITHDRAWAL OF DRUGS
Serious side effects of a
new drug may not become ap
parent until it has been in use
for some time. That hap
pened with thalidomide. It
also happened in this country
with MER29, which was
widely used for lowering
blood cholesterol levels.
By last November, FDA
had learned of four cases in
which patients taking MER
29 had developed eye cata
racts. Government scientists
wanted to suspend the drug
but were told they had no
legal power to do so under
present law unless they could
prove that MER29 was un
safe when used in the dosage
recommended on the label.
Since the recommended dos
sage had been exceeded in
three of the four cataract
cases, MER29 stayed on the
market.
Five months later, in mid
April of this year, the FDA
had acumulated evidence of
enough injuries at the recom
mended dosage to require the
withdrawal of MER29.
- The new legislation would
permit immediate suspension
of any drug when the FDA
believes that it presents an
"imminent hazard" to public
health.
Drug manufacturers hope
some safeguards will be pro
vided to insure that FDA's
withdrawal powers are not
used "capriciously."
It would be a shame to
have a good drug snatched
of. the market because some
government official panicked
over a single complaint," said
the head of one big pharma
ceutical company.
MANUFACTURING
CONTROLS
Last fall, complaints began
to pour into FDA about a
dietary supplement. Male pa
tients using it were develop
ing enlarged breasts. Female
patients had abnormal uterine
bleeding. Investigation
showed careless manufactur
ing processes had permitted
the product to become con
taminated with synthetic sex
hormones produced in the
same plant.
Present law does not give
the FDA the power to inspect
drug manufacturing pro
cesses, or to set minimum re
quirements for manufacturing
controls that will insure se
curity. Most good drug houses
are scrupulously careful on
their own initiative. But there
have been enough incidents
like the sex hormones to show
some of the nation's 1,300
drug manufacturers are not
above cutting corners and
taking chances with public
health.
The proposed legislation
would empower the govern
ment to set quality control
standards for drug manufac
ture and enforce them
through plant inspection.
The provision is viewed
with considerable concern by
an industry in which trade
secrets are jealously guarded.
Although the PMA has not
taken a stand against inspec
tion as such, it wants the
FDA's investigating powers
limited to matters directly af
fecting drug safety.
OTHER PROVISIONS
Other provisions of the
legislation would: require ad
vance government safety cer
tification for all types of anti
biotics (only five of the 35
types in wide use are now
subject to certification).
Require that drugs be iderv
tified on their labels by their
standard pharmacological
names as well as by the manu
facturer's brand name.
Tighten federal controls
over barbituates and stimu
lant drugs such as ampheta
mines which now are being
sold illegally in many areas.
Require that medical adver
tisements for new drugs ad
vise doctors about their bad
as well as their good effects.
Doctor Dis
cusses Phocomelia
A 7
and Its Treatment
(Editor's note Thousands
of babies were born with
arm and leg deformities in
Europe during the last two
or three years. In most
cases, the mothers had
taken the drug thalidomide
during pregnancy. Ger
many, hard hit by deformi
ties, is taking the lead in
treating the handicapped
children, A German doctor
discusses the problem in
ihe following dispatch.)
By ZANDER HOLLANDER
Frankfurt, Germany tUPli
."When the nurse told me
about our baby, it was like
a blow from God.
"But now I know he is a
person, a human spirit. We
love him even more than our
other normal children. We be
lieve he can have a decent
life if we do the right things
for him now."
Dr. Ekkchard Stoerig, sen
ior physician of the Frankfurt
University Orthopedic clinic,
nodded warm agreement as
Hans Schmidt let us call
him that described lis feel
ings about the son born to
his wife two years ago with
badly deformed arms and
legs.
Schmidt's son is one of an
estimated 3,000 to 5,000 chil
dren born in Germany with
such phocomelia or seal-like
deformities during the past
three years. In almost all
cases the mothers had taken
"Contergan" pills. Contcrgan
is the German trade name for
the tranquilizer drug thali
domide. More Advanced
Because the drug tragedy
hit Germany so hard. Dr.
Stoerig ruefully says German
, doctors and therapists prob
ably are further advanced in
I caring for the tiny phoco
! meiia victims than those of
other countries.
"We have made great
strides in developing therapy
techniques and prosthetic ar
tificial limbs. We had to,"
Stoerig says. "But most im
portant we have learned you
must begin right away to
treat the babies. We used to
think there was little point to
prosthetic limbs until the pa
tient was ready to start work.
Now we know to wait is disastrous."
The Frankfurt clinic re
ceived one or two phocomelia
cases a year before the wave
of birth deformities. Sudden
ly in I960 there were 10 de
formed babies; in 1961 there
were 22, and in the first five
months of 1962 there were
five.
Phocomelia is no respecter
of classes. Parents of deform
ed babies included an interior
decorator, an automobile me
chanic, a tool factory worker,
a doctor on the Frankfurt clin
ic staff and thousands of oth
ers from all walks of life.
"Your first reaction is pan-1
ic you ask yourself over
and over, why us?" said the
doctor. It was 18 months ago
that his wife, who took Con
tcrgan to counter sleepless
ness, gave birth to a son with
clubbed and crippled arms.
"Then comes reconciliation
as you icarn to know and love
the child, and you realize you
and he must make the best
of it.
"That is when you must
listen to your heart."
The doctor and his wife ac
cept the fact that their son
will always be physically
handicapped.
"But he could become a
good doctor." the father said.
"We hope for him just as for
any other 18-month-old, and
we try to treat him the same.
Of course there are differ
ences if he reached for some
thing - he is learning to grab
with his pinkie. We do have
hope that we can help him
to have a good life."
Now Loves Him
A pretty, brown - haired
young mother whose deform
ed baby is only six months
old, said, "At first I hoped
he would die he's my first,
t But now I love him."
Dr. Stoerig began therapy
on this woman's son a few
days ago.
"First we must prevent any
further damage," he explains.
"Deformed limbs can lead to
deformed spines without
speedy corrective treatment.
"Then twisted arms or legs
must be straightened. A twist
ed stump is a shaky base for
an artificial leg.
"Those little fingers in the
shoulders are valuable - they
CO
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s,.,,,, 229c
, must not be allowed to atro
I phy. We strengthen them by
LsDecial pxprrisps Whpn th.
time comes those fingers will
operate the controls of a pneu
matically . powered artificial
arm."
Dr. Stoerig has graphic
proof that rehabilitation is
possible. One picture sshows a
smiling two-year-old girl with
out arms. Others show the
same little girl two years old
er, building with blocks,
wheeling a doll carriage and
playing a toy xylophone
all with artifical arms.
Therapy Costly
The therapy is costly. Dr.
Stoerig estimates a child's
prosthetic limb costs from 2,
000 to 3,000 marks (S500 to
$750). The child probably will
need perhaps three or four
sets of artificial limbs before
he is ready for final adult-
size limbs capable of refined
adult movements.
The West German federal
health ministry is now devis
ing ways to help families of
such babies shoulder the eco
nomic burden.
"The child must have these
things," says Stoerig. "When
the time comes for normal
children to play patty-cake,
these infants must have limbs
capable of patty-cake. When
they enter school and must
learn to write they must al
ready have mastered pros
thetic arms capable of hold
ing pencils, and writing.
"These children are physi
cally one down from the mo
ment of birth," Stoerig puts
it. "They must be made
equal or even one up on nor
mal people mentally."
Equally Capable
Stoerig and his colleagues
agree phocomelia babies are
as Intelligent as normal babies
and equally capable of learn
ing. "It's more than a medical
job," Stoerig tells phocome
lia parents. "Our job is to
build the child's confidence,
to surround him with love
and, understanding, to make
sure he never loses contact
with the real world in which
he will have to make his
way."
"There is a moment I
dread," the interior decorator
said. "One day my child will
be playing in a sand pile with
other children and someone
will say, look at that cripple.
"But we are too fast to
throw a life away nowadays.
We will not throw away this
one. It will be hard,, but he
deserves a chance. He Rives
me and my wife much joy."
Butterfly's Love
Life Discussed at
Science Meeting
Corvallis - IUPII - The short,
huppy love life of the butter
fly provided a light interlude
here today for thousands of
scientist gathered to discuss
the wide aspects of biology.
The report on butterfly ro
mancing was delivered by Dr.
Lincoln P. Brower and Dr.
Florence Cranston of Amherst
college at the American In
stitute of Biological Sciences
convention.
The male of the beautiful
Queen butterfly uses per
fumed "hair pencils" to en
tice his lady, they said.
Pursuas Female
The male pursues the fe
male, overtakes ner in the air,
and induces her to alight by
brushin" her with the scented
sticks, they told the Amer
ican Society of Zoologists.
Then the courtship pro
ceeds. If the lady is willing
she folds her wings, while the
male rubs her head with his
antennae.
Then, In an age-old tradi
tion, they say, "he carries her
to an inconspicious spot,"
where the happy pair rest mo
tionless for hours. The court
ship often ends without mat
ing, the scientists added.
The report was one of many
delivered today, covering
topics ranging from bats and
crabs to the unity of biolog
ical science.
Dr. Curt Stern, president
of the American Society of
Zoologists, said in spite of its
separate approaches, the unity
jf biological science is becom
ing more apparent.
Unifying Factors
He said separate animal
and plant sciences are being
re-evaluated in terms of their
place In the overall structure
of learning. And, he said,
there is a need for emphasis
on unifying factors.
Dr. Asher Treat of City Col
lege, New York, reported on a
clever mite that lives in the
car of a moth.
The moth needs its hearing
to avoid being eaten by bats,
he said. The mites avoid their
own destruction, he said, by
never infesting but one car
of any moth.
Other reports covered
habits of hermit crabs that
live in empty snail shells, her
editary mongolism, and "how
much nucleus Is enough for
one cell."
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