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REPLY

Hospice Benefits and Phase I Cancer Trials

right arrow Ira Byock, MD, and Steven H. Miles, MD

6 January 2004 | Volume 140 Issue 1 | Page 71


IN RESPONSE:

We asserted that people who qualify for hospice care under Medicare must not be rendered ineligible for hospice services if they choose to enter a phase I trial. We do not share Dr. Avery's view that people who enroll in hospice should not be allowed to participate in phase I trials. Hospice is a service delivery model for providing palliative care. Neither research nor patient care is served by denying patients with incurable cancer the opportunity to contribute to determining safe doses for therapies that may help others. Many terminally ill patients value a sense of contributing to others (1). People with advanced, incurable cancer may well benefit from receiving hospice services as they participate in clinical research. The Promoting Excellence in End-of-Life Care program sponsored 4 cancer programs of concurrent oncology care, including participation in phase I and phase II clinical trials, and palliative care. These projects were well received by patients, families, and clinicians (2).

We agree with Dr. Trump that hospice care should be available to eligible patients who enter phase II trials to test new treatment regimens against a placebo. Such patients are misled if they believe the experimental protocols represent effective treatments and are disserved if their willingness to participate in research precludes receiving funded hospice services. Institutional review boards must examine research protocols to ensure compliance with standards for providing palliative care. They must scrutinize the informed consent process to ensure that terminally ill persons are not denied the opportunity to receive services that may benefit them and their families.


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From The Practical Ethics Center, University of Montana; Missoula, MT 59812; and Center for Bioethics, University of Minnesota; Minneapolis, MN 55455.


References
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1. Steinhauser KE, Clipp EC, McNeilly M, Christakis NA, McIntyre LM, Tulsky JA. In search of a good death: observations of patients, families, and providers Ann Intern Med. 2000;132:825-32. [PMID: 10819707].[Abstract/Free Full Text]

2. Promoting Excellence in End-of-Life Care. http://www.promotingexcellence.org. Accessed 18 May 2003.

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Related articles in Annals:

Perspectives
In Search of a Good Death: Observations of Patients, Families, and Providers
Karen E. Steinhauser, Elizabeth C. Clipp, Maya McNeilly, Nicholas A. Christakis, Lauren M. McIntyre, AND James A. Tulsky
Annals 2000 132: 825-832. [ABSTRACT][Full Text]  

Perspectives
Hospice Benefits and Phase I Cancer Trials
Ira Byock AND Steven H. Miles
Annals 2003 138: 335-337. [ABSTRACT][Full Text]  

Letters
Hospice Benefits and Phase I Cancer Trials
Robert Avery
Annals 2004 140: 70. [Full Text]  

Letters
Hospice Benefits and Phase I Cancer Trials
Donald L. Trump
Annals 2004 140: 70-71. [Full Text]  




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