Jose_Sabili

EXPERT CONFERENCE ON
THE REVISION OF
DECLARATION OF HELSINKI
IMPERIAL HOTEL, TOKYO
TOKYO, JAPAN
FEBRUARY 28, 2013 – MARCH 1, 2013
DECLARATION OF HELSINKI
RESOURCE POOR SETTING
&
“POST STUDY ARRANGEMENT”
BY
JOSE ASA SABILI, M.D.
PAST PRESIDENT, PHILIPPINE MEDICAL ASSOCIATION
CHAIRMAN, PMA COMMITTEE ON INTERNATIONAL AFFAIRS

 I
 would
 like
 to
 thank
 the
 WMA
 Organizing
 Commi8ee
 for
 allowing
 
me
  this
  opportunity
  to
  share
  my
  insights
  on
  the
  need
  to
  revise
  the
 
Declara@on
 of
 Helsinki.
 
 
 
 
 
 

  The
  advancement
  of
  technology
  in
  the
  prac@ce
  of
  medicine
  has
 
already
  provided
  cure
  to
  some
  diseases.
  This
  advancement
  of
  technology,
 
however,
 has
 equally
 unlocked
 the
 vault
 of
 problems
 that
 pose
 challenges
 for
 
medical
  prac@@oners.
  These
  challenges
  take
  the
  form
  of
  serious
  ethical
 
issues
  which
  are
  now
  brought
  into
  the
  open
  by
  several
  sectors
  of
  the
 
community.
 

 
  It
  used
  to
  be
  that
  the
  innova@ve
  medicines
  are
  first
  tested
  on
 
animals
 before
 they
 are
 tested
 on
 humans.
 Now,
 it’s
 the
 other
 way
 around
 
because
 it
 is
 the
 stem
 cells
 of
 animals
 that
 are
 now
 tested
 on
 humans.
 This
 is
 
the
 era
 of
 stem
 cell
 therapy.
 Gene@c
 engineering
 was
 first
 applied
 with
 the
 
inten@on
  of
  improving
  yield
  for
  plants,
  but
  now
  gene@c
  manipula@on
  is
 
equally
 applied
 to
 humans.
 
Introduc@on
 

 What
 are
 the
 risks
 in
 these
 so
 called
 medical
 advancement
 that
 
were
  not
  exis@ng
  before
 
  and
  more
  importantly
  what
  are
  the
  new
 
breakthrough
 of
 hope
 of
 cure
 that
 these
 new
 trends
 in
 the
 treatment
 of
 
disease
  can
  really
  offer?
 
  In
  my
  country
  alone
  there
  is
  right
  and
  leN
 
employment
 of
 the
 use
 of
 stem
 cell
 procedures.
 Even
 those
 in
 the
 non-­‐
 
medical
 field
 are
 involved
 in
 the
 treatment
 with
 use
 of
 stem
 cells.
 Even
 
some
 doctors,
 
 sad
 to
 say,
 are
 themselves
 injec@ng
 stem
 cells
 into
 their
 
veins
 in
 the
 hope
 of
 achieving
 eternal
 youth!
 

  Are
  we
  to
  ignore
  the
  fic@on
  movie
  en@tled
  “X-­‐MEN”.
  But
  of
 
course
 the
 world
 will
 be
 lucky
 if
 the
 result
 of
 the
 medical
 advancement
 
are
 the
 Avengers!
 We
 must
 remember
 that
 the
 fic@on
 of
 yesterday
 has
 
become
 the
 reali@es
 of
 today.
 Are
 these
 new
 trends
 or
 situa@on
 covered
 
by
 the
 Declara@on
 of
 Helsinki?
 
 

  Thus,
  I
  join
  the
  WMA
  in
  its
  serious
  inten@on
  to
  revise
  the
 
Declara@on
  of
  Helsinki
  and
  make
  it
  more
  responsive
  to
  the
  latest
 
developments
 in
 the
 prac@ce
 of
 medicine.
 There
 must
 be
 a
 re-­‐defining
 of
 
what
  is
  safe
  prac@ce
  of
  medicine
  in
  the
  light
  of
  all
  these
  new
  medical
 
development.
  More
  importantly,
  the
  right
  of
  the
  pa@ent
  must
  be
 
reinforced
  with
  these
  so
  called
  new
  scien@fic
  breakthrough.
  Medical
 
prac@@oner
 must
 be
 involved
 with
 fresh
 ethical
 principles
 in
 their
 effort
 
to
 cure
 the
 illnesses
 of
 their
 pa@ents.
 

 
  Let
  me
  walk
  you
  through
  a
  short
  history
  of
  the
  Revision
  of
 
Declara@on
 of
 Helsinki
 and
 its
 perspec@ve.
 
WMA DECLARATION OF HELSINKI

 
 
v 
 
 
 
 History
 
v 
 
 
 
 Relevance
 
v 
 
 
 
 Future
 

 
DECLARATION OF HELSINKI
(Past, Present & Future)

 The
 Declara@on
 of
 Helsinki
 was
 adopted
 year
 1964
 on
 the
 18th
 WMA
 
General
  Assembly
  in
  Helsinki,
  Finland
  and
  underwent
  several
 
revisions.
  It
  is
  the
  supreme
  declara@on
  pertaining
  to
  interna@onal
 
 
ethical
  standard
  in
  human
  medical
  research.
  History
  would
  reveal
 
that
 aNer
 its
 first
 major
 revision
 done
 in
 Tokyo
 in
 1975
 and
 series
 of
 
revision
 done
 in
 Italy,
 Hong
 Kong,
 South
 Africa,
 Edinburgh
 and
 Seoul,
 
South
 Korea.
 We
 are
 now
 in
 the
 process
 of
 doing
 the
 8TH
 Revision
 of
 
the
 Declara@on.
 
WMA DECLARATION OF HELSINKI
Adopted
 by
 the
 18th
 WMA
 General
 assembly;
 Helsinki,
 Finland;
 June,
 1964
 and
 
 
amended
 by
 the:
 

 
 
 
 
 29th
 WMA
 General
 Assembly
 Tokyo,
 Japan;
 Oct.,
 1975
 

 
 
 
 
 35th
 WMA
 General
 Assembly;
 Venice,
 Italy;
 Oct.,
 1983
 

 
 
 
 
 41st
 WMA
 General
 Assembly;
 Hong
 Kong;
 
 Sept.,
 1989
 

 
 
 
 
 48th
 WMA
 General
 Assembly;
 South
 Africa;
 Oct.,
 1996
 

 
 
 
 
 52nd
 WMA
 General
 Assembly;
 Edinburgh,
 Scotland;
 Oct.
 2000
 

 
 
 
 
 53rd
 WMA
 General
 Assembly;
 Washington
 2002
 
 

 
 
 
 
 55th
 WMA
 General
 Assembly;
 Tokyo
 2004
 

 
 
 
 
 59th
 WMA
 General
 Assembly;
 Seoul,
 South
 Korea;
 Oct.
 2008
 
DECLARATION OF HELSINKI
ISSUES
 
v
 Resource
 Poor
 Selng
 
v
 Post
 Study
 Arrangement
 
 
v
 Informed
 Consent
 
v
 Use
 of
 Placebo
 
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
 9
 
 

 “Medical
 Research
 is
 subject
 to
 ethical
 standards
 that
 promote
 
respect
 for
 all
 human
 subjects
 and
 protect
 their
 health
 and
 rights.
 Some
 
research
  popula@ons
  are
  par@cularly
  vulnerable
  and
  needs
  special
 
protec@on.
 These
 include
 those
 who
 cannot
 give
 or
 refuse
 consent
 for
 
themselves
  and
  those
  who
  may
  be
  vulnerable
  to
  coercion
  or
  undue
 
influence.“
 
 

 
 
 
 
 
 
 
 
 
 
 
 In
 a
 resource
 poor
 selng,
 extra
 cau@on
 must
 
be
 taken
 in
 the
 selec@on
 of
 human
 subjects,
 making
 
sure
  that
  the
  subjects
  do
  not
  give
  their
  consent
 
because
 of
 economic
 duress.
 
 
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
 13
 
 
 
 

 “Appropriate
 cau@on
 must
 be
 exercised
 in
 the
 conduct
 of
 
medical
 research
 that
 may
 harm
 the
 environment.”
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  In
  a
 
  resource
  poor
  selng,
  a
  research
 
finding
  organiza@on
  must
  also
  provide
 
appropriate
  funding
  for
  the
  disposal
  of
  the
 
research
 drugs
 or
 materials.
 
DECLARATION OF HELSINKI
(Resource Poor Setting)
ARTICLE
 15
 

 
  The
  research
  protocol
  must
  be
  submi8ed
  for
  considera@on,
 
comment,
 guidance
 and
 approval
 to
 a
 research
 ethics
 commi8ee
 before
 
the
 study
 begins.
 This
 commi8ee
 must
 be
 ………
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 In
 a
 resource
 poor
 selng,
 wherein
 there
 is
 
no
  research,
  ethics
  commi8ee
  in
  the
  physician’s
 
ins@tu@on,
  the
  physician
  must
  seek
  approval
  from
 
other
  ins@tu@on
  where
  there
  are
  research
  ethics
 
commi8ee,
 whether
 private
 or
 government.
 
 
DECLARATION OF HELSINKI
(POST STUDY ARRANGEMENT)
v
 
 
 
 
 Pa@ent
 access
 to
 best
 proven
 prophylac@c,
 diagnos@c
 and
 therapeu@c
 

 method
 iden@fied
 by
 the
 study?
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
v
 
 
 
 
 What
 happens
 to
 pa@ent
 once
 study
 is
 over?
 
v
 
 
 
 
 Who
 owes
 to
 whom
 and
 why?
 
v
 
 
 
 
 Pa@ent
 compensa@on
 for
 research
 related
 injury?
 
 
 
 
 
 
 
 
 
 
v
 
 
 
 
 Pa@ent
 access
 to
 result
 of
 research
 subject?
 
v
 
 
 
 
 Which
 way
 the
 result
 of
 clinical
 treatment,
 shall
 be
 reported?
 (Internet,
 

 Private
 or
 Public
 Publica@on
 and
 Interna@onal
 Society
 or
 PROCTOR)
 
v 
 
 
 
 
 How
 they
 must
 be
 used
 for
 developing
 clinical
 standard
 for
 medical
 care?
 
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH COMBINED WITH MEDICAL CARE

 “36
 No
 mode
 of
 treatment
 that
 has
 no
 proven
 safety
 and
 efficacy,
 
or
  when
  it
  is
  publicly
  known
  to
  be
  of
  no
  benefit
  or
  doubrul
 
benefit,
 shall
 be
 employed
 and
 where
 the
 adverse
 results
 of
 the
 
intended
  mode
  of
  treatment
  are
  irreversible
  and
 
unpredictable.”
 
  (Dr.
  Jose
  Asa
  Sabili),
  Philippine
  Medical
 
Associa@on
 Declara@on
 of
 Helsinki
 2013,
 Tokyo,
 Japan
 
At
  this
  point,
  let
  me
  quote
  from
  a
  dear
  friend
 
 
 
 
 
Dr.
  Bu
  Castro,
  a
  doctor
  lawyer
  President
  of
  the
 
Philippine
 Hospital
 Associa@on
 and
 Past
 President
 of
 
the
 Philippine
 Medical
 Associa@on
 when
 he
 says,
 
 
“ In medical research, we treat not the
present but the future…
but we must likewise protect the future
by protecting the present.”
THANK YOU SO MUCH,
I LOVE YOU ALL!!!