Sham neurosurgery in patients with Parkinson's disease: is it morally acceptable?
For a few decades, patients with Parkinson's disease (PD) have been treated with intracerebral transplantations of fetal mesencephalic tissue. The results of open trials have been variable. Double blind, placebo-controlled studies have recently been started in order to further investigate the efficacy of this new medical technique. In this paper we challenge the need for sham surgery in neurotransplantation research on PD patients. Considerations regarding the research subjects' informed consent, therapeutic misconception, the integrity of the human body, and the assessment of risks and benefits argue against sham surgery for patients with PD. Moreover, there is an alternative, less harmful mode of research that can provide the same or comparable scientific evidence. A plea is made for intrapatient research based on quantitative measurements of the patient's pre- and post-operative condition combined with similar research on a reference group of patients who have received the standard treatment.
Dekkers
W
W
Department of Ethics, Philosophy and History of Medicine, University Medical Centre, Nijmegen, The Netherlands.
Boer
G
G
D004311:Double-Blind Method; D016332:Fetal Tissue Transplantation; D006805:Human Experimentation; D006801:Humans; D019635:Neurosurgical Procedures; D010300:Parkinson Disease / Q000601:surgery*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation
D010919:Placebos