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.

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 Relatie onderzoeker - industrie Boek Speciale situatie in Frankrijk

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 Relatie onderzoeker - industrie Boek Speciale situatie in Frankrijk

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

Treatmentpatientreimbursement Prevention patient / normal person reimbursement Enhancement normal person no reimbursement

TreatmentpatientreimbursementPrevention patient / normal person reimbursement Enhancement normal person no reimbursement

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 Relatie onderzoeker - industrie Boek Speciale situatie in Frankrijk

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, France wires up to treat obsessive disorder, Sally Goodman, Nature 417, 677, June French psychiatrists

The Economist, May 25, 2002

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen Relatie onderzoeker - industrie Boek Speciale situatie in Frankrijk

Dank voor de uitnodiging Dank voor Uw aandacht