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VOLUME 21, NUMBER 7
FEBRUARY 15,1974
DURHAM, NORTH CAROLINA
Romanian Drug GH3
Being Tested at Duke
For the past 20 years, thousands of
elderly patients from Europe, Asia, Africa
and the United States have flocked to
clinics in Bucharest and Constanza, a
resort city on the Black Sea, to receive
treatments with a controversial Romanian
"youth drug" — Gerovital H3.
Now researchers at Duke are
conducting one of the first double-blind
clinical trials of Gerovital (GH3) in the
United States to determine whether it is
effective in treating mental depression
anriong the aged.
The study is designed specifically to
test the drug for mild to moderate
depression, even though Romanian
scientists have claimed that it can
overcome the effects of everything from
arthritis and angina pectoris to senility.
The principal investigator on the
project is Dr. William W. K. Zung,
professor of psychiatry, who is widely
known for his research on depression.
Last June Zung visited Professor Ana
Aslan, director of the Geriatrics Institute
in Bucharest and developer of GH3
therapy, to see how the drug is used
there.
Dr. Aslan sparked a stir throughout
the world in 1956 when she reported in a
German medical journal on the
phenomenal improvenfient in the psychic,
physiological and social functioning of
189 elderly patients who had undergone
GH3 therapy during a 10-year period.
Other investigators throughout the
world have tried to duplicate her findings,
but the results have been equivocal, and
the therapy has come under sharp
criticism.
Car Pool Stations
Established Here
To assist people in working out car
pooling arrangenfients more easily, four
car pool sub-stations will be operated
during the coming week at various spots
throughout the campus.
At the medical center, the location
will be in the first-floor corridor outside
the Personnel Office (Yellow Zone).
That's the same location where a Durham
County map, dividing the county into car
pool zones, has been mounted.
A representative from the Parking and
Traffic Office will man a desk there next
Monday-Friday (Feb. 18-22) from 8
a.m.-5 p.m.
Car Pool Information Forms were
distributed last week by payroll clerks.
Copies also are available at the Personnel
Office, at the medical center's Parking
and Traffic Office in 350 Bell Building
and at the main campus Traffic Office at
2010 Campus Drive.
Those forms are to be completed by
anyone interested in car pooling, and
mailed to the 2010 Campus Drive office.
Copies of all completed forms will be
distributed to the car pool sub-stations
for use next week in helping people
match up for rides.
One of Dr. Aslan's replies to this
criticism has been that other researchers
have not used the Romanian product
GH3 but have substituted some other
form of procaine or Novocain.
The study now being conducted at
Duke uses the Romanian drug GH3
supplied by Rom-Amer Pharmaceuticals,
Ltd. The Food and Drug Administration
last May authorized Rom-Amer to
conduct clinical trials of the drug in the
U.S. under an Investigational New Drug
application.
In the Duke study, patients receive
either GH3, or a known antidepressant
called imipramine or a supportive
medication. The study is designed so that
at some time during his two-month
participation, each patient will have
• received a full course on GH3.
This is a double-blind study, which
means neither the doctor nor the patient
knows until it is all over what drug the
patient is taking during which part of the
study. Zung said some patiients have
already entered the study, and he plans to
eventually include at least 60 patients.
Zung said no drug has ever before been
thoroughly and specifically tested for
depression in elderly patients.
Antidepressants such as imipramine have
been tested in other age groups and found
effective, but they cause side effects such
as dizziness and hypotension (low blood
pressure) which can be especially
dangerous in the elderly.
One of the benefits claimed for GH3 is
that it has almost no known side effects,
Zung said.
Investigators claim that the scientific
rationale for the reported benefits of
GH3 therapy is that the drug is an
effective monamine oxidase (MAO)
inhibitor. MAO is an enzyme which is
widely distributed in the body, especially
in the central nervous system.
Various studies have related high levels
of this enzyme to depression and other
psychiatric disorders. Other researchers
have reported a direct correlation
between aging and increased MAO
activity.
It has been speculated that the lack of
side effects is due to the fact that GH3 is
a reversible MAO inhibitor, while most
antidepressants such as imipramine are
irreversible.
Zung said patients taking part in the
study are 60 years of age and over and
have clinical diagnoses of mild or
moderate depression. Four Duke
psychiatrists are serving as the clinical
team for the project — Dr. Daniel T.
Gianturco, Dr. Eric Pfeiffer, Dr. H. Shan
Wang and Dr. Alan D. Whanger.
These four psychiatrists are
responsible for the primary care of the
patients during the study. An evaluation
team made up of Dr. Steven Potkin, Dr.
Peter Bridge and JoAnn Perry is
responsible for testing the patients
before, during and after the study using a
battery of rating scales and inventories to
determine any changes in the patients'
conditions.
ROMANIAN RESEARCHER-Ziuye psychiatrist Dr. William W. K. Zung is
shown with Dr. Ana Aslan during a visit to her Geriatrics Institute in Bucharest last
summer. Dr. Aslan, developer of Gerovital H3, spoke here yesterday at Departnfient of
Psychiatry Grand Rounds. Zung is conducting clinical trials on the effectiveness of her
drug in treating mental depression in the aged.
Personnel Paragraphs
Questions from readers are
encouraged. If you have a question, send
it to:
Personnel Paragraphs
Box 3017
AH inquiries must be signed, but you may
request that your name not be used if
your letter is published. All questions will
be answered or referred to an appropriate
source, but only questions of wide,
general interest will be published.
"Personnel Paragraphs" is your column,
so let us hear from you.
BENEFITS
The Personnel Policy Manual for
Bi-Weekly Employees lists 19 benefits.
They are: Holidays, Vacation, Sick Leave,
Jury Duty, Voting Time, Funeral Leave,
Military Leave, Retirement, Maternity
Leave, Hospital Insurance, Life Insurance,
Long Term Disability, Unemployment
Compensation, Workmen's
Compensation, Social Security,
Continuous Service Credit, Educational
Assistance, Survivor's Benefits, and Travel
Accident Insurance.
"Personnel Paragraphs" will discuss
each of these benefits in future articles
and encourages readers to write in any
questions they may have about them.
HOSPITAL INSURANCE
Permanent employees who regularly
work 20 or more hours per week are
eligible to participate in the Blue
Cross-Blue Shield Group Plan. The
university pays a portion of the premium
for employees who regularly work 30 or
more hours. There are three coverage
plans: Individual, Parent and Child, and
Family. Maternity benefits are provided
only under the Family Plan. Descriptive
literature and information on rates is
available at the Personnel Office.
Employees may enroll in the Hospital
Insurance Plan at anytime, but*employees
who do not enroll within 31 days of their
employment date will be subject to a
24-month waiting period on pre-existing
conditions.
The plan would then cover illness or
injury which occurs after the effective
date of coverage, but would not cover
treatment of conditions which existed
prior to sign-up.
The final determination of pre-existing
conditions lies with a panel of physicians
who advise Blue Cross-Blue Shield on
these matters. Employees who sign up for
insurance within 31 days of employment
date or eligibility date are not subject to
this waiting period. There is, however, a
270-day waiting period for maternity
benefits on all enrollments.
NEW BLUE CROSS-BLUE
SHIELD BENEFIT
Unmarried dependent children are
removed from certificate of coverage
upon reaching age 19, according to the
Group Plan with Parent and Child or
Family coverage. Blue Cross has issued a
new endorsement which provides that
mentally retarded and physically
handicapped children may now be
continued on the certificate of coverage
beyond age 19.
Employees with dependent coverage
will receive materials explaining the new
benefit and a form to apply for coverage.
The monthly premium will not change.