Transcript The Merck Manual

臨床試驗的科學原理
台北醫學大學
醫學科學研究所
許重義
What is the most widely read
book on medicine?
It is Merck Manual !
Western vs. Eastern
Western vs. Eastern
In Medicine, which world advances faster
and is more successful?
Eastern or Western?
Amazon.com
This is serious stuff.
The most widely used
medical text in the
world.
Ref. Amazon. com
“more than 10 million copies
sold in 18 languages
since it was first published
in 1899 “
the oldest continuously
Published general medical text
in the English language.
The year 1999 marks a milestone
in medical publishing
—the 100th anniversary of
The Merck Manual
The Merck Manual:
A Century of Medical
Publishing and Practice
A Century of Trust
The Merck Manual:
Centennial Edition
What a century
for advances
in medicine!
Keryn AG Lane
Executive Editor
Merck Manuals
Robert Berkow
Editor-in-Chief
Merck Manuals
The history of the Manual
provides a wonderful overview
of how medical practice has
changed.
The first edition reveals
a remarkable reliance
on poisons, such as strychnine
and arsenic.
Arsenic was listed as a
medication for
more than 100 diseases,
including jaundice,
hydrophobia, elephantiasis,
and impotence.
Tobacco was recommended
to treat asthma
The first edition
was an instant
success!
A book reviewer in the Chicago
Medical Recorder commented:
“Although this little book is gotten out
by a manufacturing firm----,
it nonetheless is of such merit -----.”
Dr M R Dinkelspiel,
the
th
7
edition (1940) editor
noted that therapy was approached
not as a science,
but as an art.”
The ninth edition
(1956) reflected
the growing
list of corticosteroids
for pain.
The 12th edition (1972)
contained many new chapters,
for example, on coronary
care units, cardiovascular and
malignant diseases, immunology
and genetics, and the
chemotherapy of psychiatric
disorders.
As an interesting endnote, all
people who purchase the 17th
edition of The Merck Manual
during its centennial year will
receive a facsimile copy of the
first edition.
Readers can then see
for themselves how
much medicine has
changed during this
century.
What about oriental medicine?
How much has been advanced in
herbal medicine in the past 100 years?
In the USA, herbal medicine pills
are noted frequently to contain
western medications such
as steroid (cortical),
chemotherapeutic agents
(method rebate), anticonvulsants
(Dilating) and others.
Based on the 100 years of
experience
with Merck Manual,
could we, the doctors, be looked
back “stupid” in year 2099?
In the 18th Century
Doctors are killing patients
with arsenic, strychnine and
other poisons
100 years from now
how the contemporary doctors
then would see their counterparts
100 years earlier?
Traffic death in the US:
50,000 a year
Death caused by
healthcare professionals
in the US:
100,000 a year!
Death caused by medications
prescribed by doctors in the US
200,000 a year!
Health care professionals and
the medications they prescribed
kill 6 times more people than
traffic accident in the US
Are you convinced that
doctors kill patients?
In Israel
A nation-wide physician strike
in 1972
lowered the mortality in the nation
by more than 50%
In Los Angeles, California
A partial physician strike
lowered the mortality in the city
by 18%
In Bogota, Columbia
A partial physician strike
lowered the mortality in the city
by 36%
In Singapore, Hong Kong and
Taiwan
SARS mortalities were
more than 10%
In Vietnam
SARS mortality was
5%
In Vietnam
There were no modern meds
such as antiviral agents or steroids
to treated patients
In Vietnam
There were no advanced facilities
such as negative pressure wards or
respirators to support incubated
patients
In medical practice
Doing nothing could be better than
meds or interventions such as
surgeries
In medical practice
The first thing every doctor
should know is
Do no harm
How do we know the meds
we give to patients
are helpful to patients?
How do we prove the meds we
prescribe to patients are helpful
scientifically?
It takes rigorously designed
clinical trials to confirm the
efficacy of a drug.
The gold standards for the criteria
to establish drug efficacy
was established by
Food and Drug Administration (FDA)
in the US
FDA established its reputation in a
well known act to prohibits the use
of thalidomide in the US when it was
widely used in the Europe for a
number of diseases in the 50s.
FDA, with its authoritative measures,
sets very high standards to approve
drugs that are to be approved for
prescriptions by doctors in the US.
The rest of the world has since
adapted FDA protocols in approving
prescription medications.
FDA specifically asks
if a new drug
is safe
makes patient better
keeps patient live longer
A new drug to be approved by FDA
entails extensive preclinical and
clinical tests to fulfill
the 3 major criteria
on safety, quality of life and longevity.
A new drug may take 7-10 years to
go from the lab bench to bedside
and costs hundreds of millions in US
dollars to get FDA approval.
Drug Development and Approval
Process