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Case Presentation
Vol. 18 No. 2 August 1999
Ethics Rounds Edited by Eric J. Cassell MD
Case Presentation: Are Dying Patients Too Vulnerable to Participate in Research? David Casarett, MD, MA
MJ was a 57-year-old married man with multiple myeloma. When it became clear that his disease had become refractory to chemotherapy, he discussed his options with his wife and Dr. F., his oncologist. Dr. F described hospice care but she also offered him the opportunity to participate in a phase I clinical trial of a new vaccine therapy. She explained that the goal of this trial was to assess the vaccine’s safety in humans. Although the vaccine might shrink MJ’s tumor burden, the likelihood of its potential benefit was not known. Dr. F also explained that if MJ entered the trial, he would not be allowed to use any systemic steroids, including megesterol and corticosteroids. Nor would he be allowed to take osteoclast-inhibiting drugs such as pamidronate. If any of these medications were started, she said, MJ would have to drop out of the trial. MJ and his wife asked numerous questions until they were confident that they understood the trial’s risks, benefits, and all of their alternatives. After several discussions with their chil-
The author thanks Dr. Kathy Foley for suggesting this case. David Casarett, MD, MA is a Fellow in Palliative Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, and Associate Medical Director, Wissahickon Hospice, Philadelphia, PA, USA. Address reprint requests to: David Casarett, MD, MA, Leonard Davis Institute of Health Economics, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104-6218, USA. Send your contributions to: Ethics Rounds to: Joseph J. Fins, MD, Box 297, New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10021, USA.
Journal of Pain and Symptom Management 143
dren and with MJ’s internist, Dr. R, MJ decided to enter the trial. He received his first two doses of the vaccine by subcutaneous injection 2 weeks apart. He tolerated the vaccine well, and suffered no side effects. When he returned for his next dose at 4 weeks, however, he reported that he had been experiencing increasing difficulty getting out of bed. During the past 3 days, he had also become intermittently incontinent of urine. MRI revealed diffuse tumor involvement throughout the lumbosacral spine, with evidence of cord compression at several levels. Dr. F discussed the option of IV corticosteroids for MJ’s cord compression, and she explained that MJ could elect to drop out of the trial in order to receive this treatment. She recommended that he do so. However, MJ considered the choice carefully and decided to remain in the trial. MJ’s internist, Dr. R, was surprised and angry when he learned of MJ’s decision. He spoke with Dr. F and also with the principal investigator (PI) of the vaccine trial. He argued eloquently and often emotionally that MJ’s choice was irrational and that MJ was “coerced by his illness” into participating in the vaccine trial. During the course of these conversations, Dr. R asked two questions: (1) Is it ethical to ask vulnerable patients like MJ to participate in research? (2) Is it ethical to require patients to forego proven therapy in order to be in such a trial? A conference was held with Dr. R, Dr. F, MJ and his wife, and the PI of the vaccine trial. Dr. R’s concerns were discussed by all of those present. MJ patiently explained his decision, arguing that even a small chance of improved survival was more important to him than the benefits of preserved neurological function offered by corticosteroid therapy. After the meeting, Dr. R reluctantly agreed with MJ’s decision to continue with the vaccine trial. MJ received his third and final dose of the vaccine, and his neurological status continued to deteriorate until he became paraplegic. Follow-up studies at the end of the 8-week trial could detect neither decreased tumor burden nor improved serum markers of disease. After discussion with Drs. F and R, MJ and his wife elected to enroll in the hospice. He died at home 1 week later. PII S0885-3924(99)00072-X
Ethics Rounds Edited by Eric J. Cassell MD
Case Presentation: Are Dying Patients Too Vulnerable to Participate in Research? David Casarett, MD, MA
MJ was a 57-year-old married man with multiple myeloma. When it became clear that his disease had become refractory to chemotherapy, he discussed his options with his wife and Dr. F., his oncologist. Dr. F described hospice care but she also offered him the opportunity to participate in a phase I clinical trial of a new vaccine therapy. She explained that the goal of this trial was to assess the vaccine’s safety in humans. Although the vaccine might shrink MJ’s tumor burden, the likelihood of its potential benefit was not known. Dr. F also explained that if MJ entered the trial, he would not be allowed to use any systemic steroids, including megesterol and corticosteroids. Nor would he be allowed to take osteoclast-inhibiting drugs such as pamidronate. If any of these medications were started, she said, MJ would have to drop out of the trial. MJ and his wife asked numerous questions until they were confident that they understood the trial’s risks, benefits, and all of their alternatives. After several discussions with their chil-
The author thanks Dr. Kathy Foley for suggesting this case. David Casarett, MD, MA is a Fellow in Palliative Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, and Associate Medical Director, Wissahickon Hospice, Philadelphia, PA, USA. Address reprint requests to: David Casarett, MD, MA, Leonard Davis Institute of Health Economics, University of Pennsylvania, 3641 Locust Walk, Philadelphia, PA 19104-6218, USA. Send your contributions to: Ethics Rounds to: Joseph J. Fins, MD, Box 297, New York Presbyterian Hospital, 525 East 68th Street, New York, NY 10021, USA.
Journal of Pain and Symptom Management 143
dren and with MJ’s internist, Dr. R, MJ decided to enter the trial. He received his first two doses of the vaccine by subcutaneous injection 2 weeks apart. He tolerated the vaccine well, and suffered no side effects. When he returned for his next dose at 4 weeks, however, he reported that he had been experiencing increasing difficulty getting out of bed. During the past 3 days, he had also become intermittently incontinent of urine. MRI revealed diffuse tumor involvement throughout the lumbosacral spine, with evidence of cord compression at several levels. Dr. F discussed the option of IV corticosteroids for MJ’s cord compression, and she explained that MJ could elect to drop out of the trial in order to receive this treatment. She recommended that he do so. However, MJ considered the choice carefully and decided to remain in the trial. MJ’s internist, Dr. R, was surprised and angry when he learned of MJ’s decision. He spoke with Dr. F and also with the principal investigator (PI) of the vaccine trial. He argued eloquently and often emotionally that MJ’s choice was irrational and that MJ was “coerced by his illness” into participating in the vaccine trial. During the course of these conversations, Dr. R asked two questions: (1) Is it ethical to ask vulnerable patients like MJ to participate in research? (2) Is it ethical to require patients to forego proven therapy in order to be in such a trial? A conference was held with Dr. R, Dr. F, MJ and his wife, and the PI of the vaccine trial. Dr. R’s concerns were discussed by all of those present. MJ patiently explained his decision, arguing that even a small chance of improved survival was more important to him than the benefits of preserved neurological function offered by corticosteroid therapy. After the meeting, Dr. R reluctantly agreed with MJ’s decision to continue with the vaccine trial. MJ received his third and final dose of the vaccine, and his neurological status continued to deteriorate until he became paraplegic. Follow-up studies at the end of the 8-week trial could detect neither decreased tumor burden nor improved serum markers of disease. After discussion with Drs. F and R, MJ and his wife elected to enroll in the hospice. He died at home 1 week later. PII S0885-3924(99)00072-X