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To the Editor: In their Commentary, Dr Pearson and colleagues¹ presented a timely discussion of the ethics of research participation as a condition of coverage. We agree that this arrangement may be morally justified, as considerable uncertainty often exists for many years about the effectiveness and the safety of new therapies.² Coverage with evidence development could become an important tool to reduce the abuse of emerging technologies while increasing knowledge about their true efficacy.³

The best way to evaluate efficacy, however, is a double-blind RCT. There is a significant ethical difference between mandating that patients agree to have their clinical data entered into a registry and mandating enrollment into an RCT in order to get coverage. In the latter option, the patient would have only a 50% chance of getting the active therapy (and a 50% chance of getting a placebo). This is not technically "coercive" and perhaps the 50% . . . [Full Text of this Article]

Mayer Brezis, MD, MPH
brezis@vms.huji.ac.il
Hadassah-Hebrew University Hospital
Jerusalem, Israel

Lisa Soleymani Lehmann, MD, PhD, MSc
Brigham and Women's Hospital Center for Bioethics
Boston, Mass

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Medicare Requirement for Research Participation
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Medicare Requirement for Research Participation—Reply
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