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Vulnerable Brains: Research Ethics and Neurosurgical Patients

Published online by Cambridge University Press:  01 January 2021

Paul J. Ford
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Extract

The vulnerability of patients receiving significantly innovative neurosurgical procedures, either as research or as non-standard therapy, presents particularly potent challenges for those attempting to substantially advance clinical Neurosurgical practice in the most ethically and efficacious manner. This beginning formulation has built into it several important notions about research participation, balancing values, and clinical advancement in the context of neurological illness. For the time being, allow vulnerability to act as a placeholder for circumstances or states of being wherein the established checks and balances of power and interest are no longer sufficient in promoting the just treatment of persons. Further, the phrase to substantially advance Neurosurgical practice encompasses radical innovation as well as significant research into new procedures. Finally, few of these explorations involve true randomized placebo controlled trials, but rather they enroll patients rightfully hoping for some benefit by means of undergoing the procedure.

When a neurosurgeon asks me, as an ethicist, to meet with a patient who has medically refractory disease and no good standard therapy options remaining, he is asking for help concerning whether to offer, as a last chance, an unproven therapy as either innovation or research.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 1 , Spring 2009 , pp. 73 - 82
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

For the sake of transparency, my perspective is deeply influenced by my regular collaboration with neurosurgeons in my job as a clinical bioethicist. Further, although I am a philosopher by training, I also belong to three neurosurgical societies and am a full member of the ethics committee for one of those societies.Google Scholar
The term “treatment” has a potentially dual meaning in this context. First, it means the behavior toward a person. Second, it means attempting to medically cure for a person. This is not intended to be a claim about the efficacy of attempt to cure or ameliorate the medical condition through the research or innovation. Simply it is meant as the appropriate relation to a person.Google Scholar
I fully appreciate the distinctions often drawn between innovation and research. However, the territory of interest in neurosurgery involves that vague intersection and adjoining territory in these concepts. This will be discussed several times throughout the article. New procedures can be procedures that are new techniques, new devices, or new application of procedures or devices.Google Scholar
The term patient is purposely used instead of subject since both the surgeon and person being operated on are hoping, or expecting, a clinical improvement. This use of “patient” is chosen with the full appreciation of the complex discussions that occur regarding “participant” or “subject” in research.Google Scholar
See Baumeister, A. A., “The Tulane Electrical Brain Simulation Program: A Historical Case Study in Medical Ethics,” Journal of the History of the Neurosciences 9, no. 3 (2000): 262–278; Pressman, J. D., Last Resort: Psychosurgery and the Limits of Medicine (New York: Cambridge University Press, 1998).Google Scholar
We will set aside for now the interesting challenge of pharmaceuticals and biologics that use molecular tagging to be attracted to specific cells. That type of technology is an exception to the generalization about pharmaceuticals.Google Scholar
Of course electrical neurostimulators are a hybrid of these two, where there is a minimal damage while affecting only a limited area within the brain.Google Scholar
I draw explicitly on the language of Ken Kipnis used in his seminal article on pediatric research. Given that I draw on the Kipnis article, it might seem a little odd for the paper to explicitly avoid the special considerations of pediatric neurosurgery. However, pediatrics creates another layer of complexity deserving a fuller exploration in itself. See Kipnis, K., “Seven Vulnerabilities in the Pediatric Research Subject,” Theoretical Medicine and Bioethics 24, no. 2 (2003): 107–120.CrossRefGoogle Scholar
For instance see Mastroianni, A. C., “Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy,” Health Matrix Cleveland, Ohio 15, no. 2 (2006): 351–442.Google Scholar
See Wiebe, S. Jette, N., “Randomized Trials and Collaborative Research in Epilepsy Surgery: Future Directions,” Canadian Journal of Neurological Sciences 33, no. 4 (2006): 365–371.CrossRefGoogle Scholar
See Fins, J. J., “From Psychosurgery to Neuromodulation and Palliation: History's Lessons for the Ethical Conduct and Regulation of Neuropsychiatric Research,” Neurosurgery Clinics of North America 14 (2003): 303–319; Ford, P. J. Henderson, J. M., “The Clinical and Research Ethics of Neuromodulation,” Neuromodulation 9, no. 4 (2006): 249–252.CrossRefGoogle Scholar
For an interesting discussion between surgical and pharmaceutical research see Paradis, C., “Bias in Surgical Research,” Annals of Surgery 248, no. 2 (2008): 180–188.CrossRefGoogle Scholar
The two major professional societies, Congress of Neurological Surgeons (CNS) and the American Association of Neurological Surgeons (AANS) both break the subspecialties into the following areas: Spine and peripheral nerves; stereotactic and functional neurosurgery; tumors; pediatric; neurotrauma and critical care; pain; and cerebrovascular. However, for the purposes of this paper, this way of distinguishing things is less helpful.Google Scholar
See Bernstein, M. Bampoe, J., “Surgical Innovation or Surgical Evolution: An Ethical and Practical Guide to Handling Novel Neurosurgical Procedures,” Journal of Neurosurgery 100 (2004): 2–7.CrossRefGoogle Scholar
See Ford, P. J. Kubu, C. S., “Stimulating Debate: Ethics in a Multidisciplinary Functional Neurosurgery Committee,” Journal of Medical Ethics 32, no. 2 (2006):106–109.CrossRefGoogle Scholar
See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Use of Psychosurgery in Practice and Research: Report and Recommendations, 42 Fed. Reg. 26318 (1977); Fins, J. J. Rezai, A. R. Greenberg, B. D., “Psychosurgery: Avoiding an Ethical Redux While Advancing a Therapeutic Future,” Neurosurgery 59, no. 4 (2006): 713–716.Google Scholar
This point is well made in C. M. Simon's observations of an early Gamma Knife clinical care committee. See Simon, C. M., “Images and Image: Technology and the Social Politics of Revealing Disorder in a North American Hospital,” Medical Anthropology Quarterly 13 (1999):141–162.CrossRefGoogle Scholar
One may argue further that a review from an outside neurosurgeon might provide a benefit in terms of risk management. This could be a secondary benefit and perhaps an extra incentive to implement this practice.Google Scholar
See Leentjens, A. F., “Manipulation of Mental Competence: An Ethical Problem in Case of Electrical Stimulation of the Subthalamic Nucleus for Severe Parkinson's disease,” Ned Tijdschr Geneeskd 148, no. 28 (2004): 1394–1398.Google Scholar
See Farris, S. Giroux, M. DeMarco, J. P. Ford, P. J., “Deep Brain Stimulation for Risky Patients: Ethical Considerations,” Movement Disorders 23, no. 14 (2008): 1973–1976.Google Scholar
This argument may be found in Ford, P. J., “Neurosurgical Implants: Clinical Protocol Considerations,” Cambridge Quarterly of Healthcare Ethics 16, no. 3 (2007): 310–313.CrossRefGoogle Scholar
See Ford, P. J. Boulis, N. Montgomery, E. Rezai, A., “Ethical Dilemmas When a Patient Intraoperatively Revokes Consent,” Neuromodulation 10, no. 4 (2007): 259–262.Google Scholar
See Racine, E. Waldman, S. Palmour, N. Risse, D. Illes, J., “Currents of Hope: Neurostimulation Techniques in U.S. and U.K. Print Media,” Cambridge Quarterly of Healthcare Ethics 16, no. 3 (2007): 312–316.CrossRefGoogle Scholar
Id.Google Scholar
Thanks to Leah Schaffer for her structured search during a summer internship. These results are yet unpublished.Google Scholar
A great deal of literature exists on therapeutic misconception. Of particular interest is Jonathan Kimmelman's analysis of the ways in which the therapeutic misconception has been improperly expanded to include concerns such as the one I raise. However, the concern of poor decision making because of over optimistic views has been interwoven within the therapeutic misconception debate. See Kimmelman, J., “The Therapeutic Misconception at 25: Treatment, Research, and Confusion,” Hastings Center Report 37, no. 6 (2007): 36–42.CrossRefGoogle Scholar
Frank, S. Kieburtz, K. Holloway, R., “What Is the Risk of Sham Surgery in Parkinson Disease Clinical Trials? A Review of Published Reports,” Neurology 65, no. 7 (2005): 1101–1103; Frank, S. A. Wilson, R. Holloway, R. G. Zimmerman, C. Peterson, D. R. Kieburtz, K. Kim, S. Y., “Ethics of Sham Surgery: Perspective of Patients,” Movement Disorders 1 (2008): 63–68; Horng, S. H. Miller, F. G., “Placebocontrolled Procedural Trials for Neurological Conditions,” Neurotherapeutics 4, no. 3 (2007): 531–536.CrossRefGoogle Scholar
Benabid, A. L., “What the Future Holds for Deep Brain Stimulation,” Expert Review of Medical Devices 4, no. 5 (2007): 895–903.CrossRefGoogle Scholar
Bernstein and Bampoe refer to the inclination to have an increasingly large number of activities fall under IRB purview as “IRB Creep” that should be avoided since they begin to take on more responsibility than they are charged with or qualified for. See Bernstein, Bampoe, , supra note 14.Google Scholar