Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling Bart Nuttin, Loes Gabriëls.

Presentatie over: "Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling Bart Nuttin, Loes Gabriëls."— Transcript van de presentatie:

1 Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling Bart Nuttin, Loes Gabriëls

2 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, …

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

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

5 DBS in psychiatric disorders Neurosurgical Clinics of North America, 14: XV-XVI, 2003

6 Research in this domain should meet the following minimal requirements :

7 Study requirements 1. An ethics committee should approve the investigational protocol

8 Study requirements 2. A patient assessment committee should evaluate each patient

9 Acceptability of capsulotomy and DBS for OCD 84 psychiatrists questioned 73 (87%) completed anonymous questionnaire

10 Requirements for the decision for capsulotomy or DBS neurosurgeon+pt 0%  + neurosurgeon+pt 3% committee+  +neurosurgeon+pt 97%

11 Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy.

12 FDA 2009 : Humanitarian device exemption (HDE) for DBS in OCD

13 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

14 Study requirements 3. Candidates for DBS surgery should meet defined criteria for severity, chronicity, disability and treatment refractoriness

15 Study requirements 4. Able to provide their informed consent.

16 Study requirements 5. The study should be conducted at or supervised by a clinical research center.

17 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

18 Study requirements 7. The procedure should never be performed for political, law enforcement, or social purposes.

19 Study requirements Investigations in this area should proceed cautiously to maintain the trust necessary for scientific progress.

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

21 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

22 Disclosure Medtronic is providing grants for research, education and traveling Patent : DBS in OCD Grants : OT, FWO, IWT, SBO

23 This work can not go forward without interactions with industry

24 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

25 Investigators should, “disclose and justify” why receipt of corporate funding is needed to sustain the work

26 Investigators should seek to balance funding from corporate sources and other funders in order to dilute perceived and real conflicts.

27 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

28 Investigators should err on the side of over-disclosure to ensure transparency.

29 Investigators should not publish data in journals whose editorial content is controlled by their sponsor.

30 Investigators should not be precluded from publishing negative results

31 –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

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

33

34 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

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

36 TreatmentpatientreimbursementPrevention patient / normal person reimbursement Enhancement normal person no reimbursement

37 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

38 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

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

40 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

41 The Economist, May 25, 2002

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

43 Dank voor de uitnodiging Dank voor Uw aandacht