Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek

en behandeling

Bart Nuttin, Loes Gabriëls

• 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, …

• Brown University : Friehs, Rasmussen, Greenberg, …• Cleveland Clinic : Rezai, Malone, …• Köln : Sturm, Klosterkötter, …• University of Michigan : Curtis, Abelson, …• Orlando : Goodman, Okun, Foot, …

• Amsterdam – Utrecht : Bosch, Schuurman, …• Grenoble : Benabid, …

• 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 0%+ neurosurgeon+pt 3%committee++neurosurgeon+pt 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

• 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

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.

• Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

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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 step-back 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

– 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)

Relationship medical researchers – industry

• Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

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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 BrainChanging Psyche and Society

(Springer Verlag)

Recommendations

TreatmentTreatment patientpatient reimbursemereimbursementnt

PreventionPrevention patient / patient / normal normal personperson

reimbursemereimbursementnt

EnhancementEnhancement normal normal personperson

no no reimbursemereimbursementnt

TreatmentTreatment patientpatient reimbursemereimbursementnt

PreventionPrevention patient / patient / normal normal personperson

reimbursemereimbursementnt

EnhancementEnhancement normal normal personperson

no no reimbursemereimbursementnt

Enhancement

If availability of purchasable mental enhancements increases

It may lead to unequal social distribution of wealth, and hence of social opportunities

Governments should counteract

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 psychiatrische stoornissen

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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

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Dank voor de uitnodiging

Dank voor Uw aandacht