Palliative care and the ethics of research: Medicare, hospice, and phase I trials.

Correspondence to: Ira Byock, MD, Director, Promoting Excellence in End-of-Life Care, a national program of The Robert Wood Johnson Foundation Practical Ethics Center, University of Montana, 1000 E. Beckwith Avenue, Missoula, MT 59812; telephone (406) 243-6601; fax (406) 243-6633; e-mail: [email protected] symptoms that erode their quality of life. They are often anxious and justifiably worried about the future—both for themselves and their families’. It is well recognized that, despite being formally informed that research is not intended or likely to help them, patients with far-advanced illness frequently enter clinical trials in the hope that the experimental treatments will extend their lives. The understandable tendency to grasp at any chance for survival, however tenuous, renders such patients at risk of being influenced by a health system and research culture that are wholly focused on fighting disease and extending life. Attention to people’s quality of life, family experience, and family support can easily get lost in the process– not intentionally, but because our protocols don’t include them, and customary measurement tools do not encompass these domains of illness. Basic issues of patients’ personal values, individual choice, and informed consent need to be revisited in light of current end-of-life research and recent advances in the delivery of health services and clinical palliative care. Recently, a number of authors have called attention to ethical issues of research involving terminally ill people [1, 2], and a conference was convened in September 2002, jointly sponsored by the National Institutes of Health and the Greenwall Foundation, a private healthcare philanthropy, to address the subject. In a recent issue of the Annals of Internal Medicine, Dr. Steve Miles and I addressed one of these issues—the exclusion by payers of coverage for hospice care of patients who are eligible for services but who decide to enter clinical trials [3]. For the sake of brevity, the article focused on Medicare beneficiaries with advanced cancer who meet criteria for hospice care but, because of their decision to enter a phase I cancer clinical trial, effectively lose access to hospice services. We pointed out that there is no clinical or ethical justification for this situation. Hospice care comprises an array of services that many patients with advanced cancer and families value highly. Although Medicare requires patients who accept hospice care to forgo Part A benefits along with most life-prolonging care, phase I trials that test toxicity and safe dosing of new treatments are not intended to be therapeutic. We pointed out that despite the potential benefits of hospice to patients and their families, routine consent processes for phase I research and the forms people are asked to sign do not disclose that participants will forfeit access to hospice services.