neuromodulatie en psychiatrie ethische implicaties bij onderzoek

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Neuromodulatie en psychiatrie :
ethische implicaties bij onderzoek
en behandeling
Bart Nuttin, Loes Gabriëls
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K.U. Leuven : Gabriëls, van Kuyck,
Welkenhuysen, Luyten, Ahmed, Prodanov, Van
Laere, Dupont, Sunaert, Demeulemeester,
Gybels, Tousseyn, Dewil, Vandenbroeck, Brak,
Das, Arckens, Nuttin.
Universiteit Antwerpen : Cosyns, Neefs,
Vankerckhoven, Cluydts, …
Karolinska : Meyerson, Linderoth, Andréewitch,
Mindus, Rück, …
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Brown University : Friehs, Rasmussen,
Greenberg, …
Cleveland Clinic : Rezai, Malone, …
Köln : Sturm, Klosterkötter, …
University of Michigan : Curtis, Abelson, …
Orlando : Goodman, Okun, Foot, …
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Amsterdam – Utrecht : Bosch, Schuurman, …
Grenoble : Benabid, …
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Medtronic Inc. : Mullett, Gielen, Rise,
Stypulkowski, Langevin, …
• Richtlijnen elektrische hersenstimulatie voor
psychiatrische stoornissen
• Relatie onderzoeker - industrie
• Boek
• Speciale situatie in Frankrijk
• Richtlijnen elektrische
hersenstimulatie voor
psychiatrische stoornissen
• Relatie onderzoeker - industrie
• Boek
• Speciale situatie in Frankrijk
DBS in psychiatric
disorders
Neurosurgical Clinics of North America, 14:
XV-XVI, 2003
Research in this domain should meet
the following minimal requirements :
Study
requirements
1. An ethics committee should
approve the investigational
protocol
Study
requirements
2. A patient assessment committee
should evaluate each patient
Acceptability of capsulotomy and
DBS for OCD
• 84 psychiatrists questioned
• 73 (87%) completed anonymous questionnaire
Requirements for the decision
for capsulotomy or DBS
neurosurgeon +pt
+ neurosurgeon+pt
committee++neurosurgeon+pt
0%
3%
97%
• Treatment of psychiatric patients
with DBS remains investigational
and is NOT considered standard
therapy.
• Treatment of psychiatric patients
with DBS remains investigational
and is NOT considered standard
therapy.
FDA 2009 : Humanitarian
device exemption (HDE)
for DBS in OCD
In Europe : CE-mark
• Treatment of psychiatric patients
with DBS remains investigational
and is NOT considered standard
therapy.
FDA 2009 : Humanitarian
device exemption (HDE)
for DBS in OCD
Study
requirements
3. Candidates for DBS surgery
should meet defined criteria for
severity, chronicity, disability and
treatment refractoriness
Study
requirements
4. Able to provide their informed
consent.
Study
requirements
5. The study should be conducted at
or supervised by a clinical
research center.
Study
requirements
6. The investigative team :
A. A functional neurosurgical
team with established
experience in DBS
B. A team of psychiatrists with
extensive experience in the
psychiatric condition under
investigation
Study
requirements
7. The procedure should never be
performed for political, law
enforcement, or social purposes.
Study
requirements
• Investigations in this area should
proceed cautiously to maintain the
trust necessary for scientific
progress.
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An Ethical Manifesto for
Researchers, Engineers and Clinicians
engaged in the Development of Therapeutic
Deep Brain Stimulation
J. Fins, T. Schlaepfer, B. Nuttin, C. Kubu,
T. Galert, V. Sturm, R. Merkel, H. Mayberg
November 16, 2010
Disclosure
• Medtronic is providing grants for
research, education and traveling
• Patent : DBS in OCD
• Grants : OT, FWO, IWT, SBO
• This work can not go forward
without interactions with industry
• Investigators should not be driven
by self-interest when pursuing
corporate support
but
• They should be motivated by a
desire to pursue important
scientific work to enhance access
to novel therapies
• Investigators should, “disclose and
justify” why receipt of corporate
funding is needed to sustain the
work
• Investigators should seek to
balance funding from corporate
sources and other funders in order
to dilute perceived and real
conflicts.
• Conflicted investigators should be
able to pursue their scientific work
in order to elucidate mechanism of
action and ensure the safety of
early phase studies.
• But they should assume a stepback role as soon as feasible in
order to minimize the possibility
generating data which might be
open to critique
• Investigators should err on the
side of over-disclosure to ensure
transparency.
• Investigators should not publish
data in journals whose editorial
content is controlled by their
sponsor.
• Investigators should not be
precluded from publishing
negative results
Relationship medical researchers
– industry
– Some journals view it as disqualifying,
despite the critical content of the
argument
– Others accept mere disclosure
– Such conflict of interest, if properly
disclosed and managed, should be
viewed with editorial neutrality (European
Academy)
• Richtlijnen elektrische hersenstimulatie voor
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Europäische Akademie zur Erforschung von
Folgen wissenschaftlich-technischer
Entwicklungen Bad Neuenahr-Ahrweiler GmbH
Merckel R, Boer G, Galert T, Fegert J,
Hartman D, Nuttin B, Rosahl S
Intervening in the Brain
Changing Psyche and Society
(Springer Verlag)
Recommendations
Treatment
patient
reimbursement
Prevention
patient /
normal person
reimbursement
Enhancement
normal person
no
reimbursement
Treatment
patient
reimbursement
Prevention
patient /
normal person
reimbursement
Enhancement
normal person
no
reimbursement
Enhancement
If availability of purchasable mental
enhancements increases
Governments
should counteract
It may lead to unequal social distribution of
wealth, and hence of social opportunities
DBS for psychiatric disorders
in prisoners
• Not in the research phase (one
should not use vulnerable people
for research)
• DBS for freedom versus DBS for
treatment
Try to untie both
• Richtlijnen elektrische hersenstimulatie voor
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• Comité consultatif National d’Ethique
pour les sciences de la vie et de la
santé, Avis N°71 24 La
neurochirurgie fonctionelle
d’affections psychiatriques sévères,
2002.
• France wires up to treat obsessive
disorder, Sally Goodman, Nature
417, 677, June 2002.
• French psychiatrists
The Economist, May 25, 2002
• Richtlijnen elektrische hersenstimulatie voor
psychiatrische stoornissen
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Dank voor de uitnodiging
Dank voor Uw aandacht
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