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Ethical Aspects in Trials of Implantable Medical Devices—Reply
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In Reply: We agree with Dr Heckerling that sham surgery can be ethical and often is necessary for the appropriate investigation of new surgical procedures. There is an important distinction, however, between sham surgery and the implantation of pacemakers for the purpose of controlling vasovagal syncope. Sham surgery implies that the intervention has no therapeutic potential. In our study, the control patients actually received a functional pacemaker, which was temporarily deactivated for the purpose of the study. At the time of initiation of our trial there was considerable evidence that pacemaker therapy was beneficial for the management of vasovagal syncope. In fact, the practice guidelines published by major organizations recommend the use of pacemaker therapy in this setting.1
Patients in our trial likely would have received a pacemaker for the management of their vasovagal syncope even if they had not been enrolled in the trial. Furthermore, the results of our . . . [Full Text of this Article]
Stuart J. Connolly, MD;
Bruce L. Wilkoff, MD;
Carlos Morillo, MD;
Robert Sheldon, MD;
Michael Gent, DSc;
Robin S. Roberts, MTech;
, MD Kenneth A. Ellenbogen for the VPS II Investigators
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Ethical Aspects in Trials of Implantable Medical Devices
Paul S. Heckerling
JAMA. 2003;290(12):1579.
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