BSS
Nov. 17, 2004
Bryan Liang: End of Life Issues: The Case of An Elderly Breast Cancer Patient
Case summary (see PowerPoint slides for full details)
The case of Mrs. A, an 82 year old woman with advanced breast cancer, brings together a number of key issues in end of life care, exhibiting that physicians and other healthcare professionals need better training in how best to live up to the trust patients put in them. This is true most notably in relation to the issue of informed consent and the execution of advance directives.
Dr. F. found himself under review for a number of questionable practices in caring for Mrs. A., most prominently beginning Ms. A on a Lupron regimen that mimics treatment for endometriosis. This drug is not approved for breast cancer, nor did Dr. F. consult with colleagues or the drug company. Moreover, he proceeded without IRB approval and without obtaining his patient’s formal informed consent. Just prior to Mrs. A’s death, Dr. F. also acted to revive her in direct contradiction to her stated wishes that “. . . there shouldn’t be any jumping on me when I’m ready to die.” Although the patient died, she did so in a way that violated her advance directive.
Discussion Summary
• In claiming that in offering to “be a guinea pig in a medical study”, Mrs. A had agreed to the off-label regime, Dr. F. demonstrated a very uninformed notion of what informed consent means.
• Informal consent to experimentation provides a low standard of consent. It is not “good enough.” One problem here is that Dr. F. didn’t recognize the inadequacy of the consent he had obtained, thus illustrating his need for far more nuanced training in the meaning of informed consent.
• Aside from the issue of informed consent, Dr. F.’s off-label use of drugs raises serious issues about the line between acceptable practice and unwarranted “experimentation.” The frequency of off-label prescribing is a matter of concern even when the outcome is positive.
• Although his actions no doubt sprang from Dr. F’s desire to extend his patient’s life, he did so without adequate consultation and review, thus risking his patient’s safety and well-being. Given that Lupron had not been approved for breast cancer treatment, the overwhelming possibility was that it wouldn’t help Mrs. A, thus subjecting an already ill patient to needless risk.
• Dr. F.’s efforts to resuscitate his patient contrary to her stated wishes manifested a similar pattern of acting alone and without adequate thought for the long term best interest of his patient.
• Does this case meet the legal standard of “malpractice”?
• Prevention of medical malpractice requires a systems approach, where medical error is recognized as the responsibility not only of individual errant physicians but also of the relevant institutions (department chairs, mentors, drug delivery systems, charting, etc.).
• Given the potential for harm – and the liability issues involved -- medical students, interns and residents need to have a nuanced and firm grasp of the meaning of informed consent, the procedures for using drugs “off label,” and how to work with their patients in insuring the best quality of life possible at the end of life.
• Improving the quality of medical care may require a fundamental change in the handling of medical errors, moving from a model of “blame” to one of community review, education and retraining. The system in which Dr. F trained helped to create both the circumstances in which he found himself and his belief that his actions were acceptable. That system of medical training and administrative “checks and balances” needs examination and rectification to reduce medical error, retrain errant practitioners and preserve the investment society makes in medical training.