By Leah D. Ward, MSN, MA, A-GNP-C, ACHPN
This week we are sharing a post that addresses a controversial topic in a provocative manner. What are the odds? Thank you to Leah Ward, a nurse practitioner who is an emerging thought leader. She currently works in community palliative care while studying for her PhD and raising a family. I thank her for taking the time to contribute to the blog while I am away.
This post is dedicated to Norma Jean Kay Foss, mother of our beloved local nursing professor, Linda Kowalczuk. She chose to spend her last days on meaningful visits with family in lieu of non-goal concordant care. I pray for this outcome for all that I care for.
On a beautiful Saturday evening in September, I was sitting beside our family’s annual fall bonfire chatting with a beloved colleague and local professor, Linda Kowalczuk who had helped me in my early days as a nurse practitioner at a residential treatment center. This evening the conversation turned to the story of her mother, which mirrored so many of the cases I had and would continue to have in a home-based palliative care setting serving managed care members with complex chronic illnesses.
A few years earlier, Linda had gotten word of her mother’s diagnosis, a stage IV lung cancer, with extensive metastasis and had been scheduled for follow-up at the local oncology clinic. Her mother was promptly placed on palliative care, though that was not explained to her. She was scheduled for immunotherapy, as so many oncology patients are, but the prognosis or expected outcomes of the treatment were not reviewed, nor were the common side effects. She was getting phone calls from the billing department that needed a down payment of $10,000 to begin treatment, when her daughter, our local professor, caught word of this and decided to do a little digging. Soon she realized that along with the high price tag came a limited efficacy in end-stage disease of just a 15-25% response rate for a chance to live 6-18 months longer, accompanied by high risks of “everything-itis”, such as hepatitis, thyroiditis, pneumonitis, uveitis, colitis, and pancreatitis when the immune system starts turning on itself as well as the cancer (1). She decided that the situation seemed a little more like extortion than medical care and had to explain to her mother that she was on palliative care because of the extensive nature of the disease, was likely to have a very limited prognosis, and the money may not be worth it due to efficacy and side effects. It was an uncomfortable position for a daughter to be in and she wasn’t happy that so little was explained, but so many calls were coming in for the “billing bonanza”, as our host blogger Rebecca Gagne-Henderson would say. A patient once told me that their insurance was billed $40,000 every three weeks for immunotherapy and would reimburse $18,000. Many have considerable copays, lose their house, and die with debts that their families will have to pay from the descendent’s estate. This was all very reminiscent of my daily life in palliative care, for which our professor had gotten a crash course when helping her mom.
It begs the question of “what is ethical?” What is right? What is decent? Were the family values and knowledge level assessed and what was most important to this family? Most families don’t have their own nursing professor to find and explain those answers, and only a select few, will be assigned to a palliative care provider who may assess family values and knowledge to determine the patient-centered goals of care. The World Health Organization estimates that just 14 percent worldwide who are in need of palliative care will receive it (2). The rest may die with severe symptoms or a non-goal concordant death, with little knowledge of prognosis, how they would like to plan their last year of life or the risks involved in treatments. Their family may pay the bills after they die as a reminder of the care that wasn’t person-centered and didn’t work out as they’d hoped.
The newest text on palliative care ethics points out that ethical approaches in palliative care vary widely depending on laws, culture, prognostic and existential uncertainty, and the spiritual self-care of the clinician providing the care. When we examine and understand what gives meaning to our own lives through spiritual self-care, only then can we understand the framework for what we will understand to be most ethical (3). The four ethical principles of autonomy (respect for patients’ decisions about their health care), beneficence (our obligation to do good through our actions as clinicians), non-maleficence (our obligations to avoid harm to the patient), and justice (fair distribution of resources that avoids expensive and non-beneficial care at the end of life) remain the guiding principles for palliative care (4).
Last year, I cared for a dying patient with a high level of symptom burden who, instead of being referred for hospice, was instead scheduled for immunotherapy. She was declining so rapidly that it seemed unlikely that she would be able to safely leave her home for appointments. A question loomed in my mind. Why are they referring this patient for immunotherapy every three weeks when three weeks may easily exceed her prognosis and immunotherapy takes much longer than a few weeks to work? Her BMI was just 14 and she was in constant pain that I was treating in collaboration with the oncology clinic. I had begun hospice teaching, but she had wanted to try the immunotherapy that had been recommended by her oncologist. By the end of the month, she had lost her insurance and could not afford the COBRA insurance that would cost thousands of dollars a month. Immediately, she was referred to a non-profit hospice that would send her a weekly visit for free, which was not adequate for her rapidly declining condition and eventually the hospital took her for inpatient hospice even though she had no pay source. It had appeared as though so many decisions regarding end of life were financially motivated. She may have actually suffered less due to losing her insurance when the recommendation to forgo hospice care in lieu of immunotherapy had dissipated as quickly as her health coverage.
While few studies have examined the ethical implications of immunotherapy, a study by Ren et al. (2019) identified several ethical considerations (5). They note that with the promising results of certain types of cellular immunotherapy, clinical trials are increasing throughout the world. These clinical trials may cause the health care consumer to forgo standard treatments. Weak admission criteria and equipment that doesn’t meet technical requirements can compound ethical dilemmas. Safety is affected by weak admission criteria and limited competence in communication skills of the researchers that impact their ability to detect and explain risks to patients, such as cytokine storms. The authors point out that the moral access of the researchers must not only focus on the research results but also assess potential risks to patients to avoid violations of the four ethical principles. Patients are often unable to distinguish between clinical treatment and medical research, causing many misunderstandings (6). Nationwide phase I clinical trials result in favorable therapeutic outcomes only five percent of the time (7). I have yet to meet any patient who knew this or was explained this when consenting to a clinical trial.
Additionally, ethical issues arise from experimental design and evaluation criteria which cannot establish a standard of practice for evaluating safety and efficacy due to the complexity and diversity of cancer cellular immunotherapy. The patient’s right to know is not adhered to due to the secrecy of double-blind trials where the patient is not aware of which treatment they received, whether it be placebo or the study drug. Ren et al. (2019) advocate for strict safety standards, training and more standardization of practices to protect the patient and adhere to the principle of non-maleficence (5).
To be fair, many will benefit, at least for a time, from the use of immunotherapy. Roughly 15-25 percent will live from 6-18 months longer and a few will do even better living 2-5 years. For those who don’t, rarely was it explained to them that the treatment had limitations, is not a miracle drug, and can not work indefinitely. Because this was not explained or planned for, a disturbing trend perpetuates. Though suffering from pain, fatigue, a decline in appetite, and a decline in mobility many will refuse hospice services, not understanding that the treatment was always expected to fail eventually. Without a basic understanding of the limitations and the prognosis, they can not obtain a peaceful death with dignity that can be offered through end-of-life care from local hospices and palliative care practices and will head into crisis again and again due to progressing disease and a heavy symptom burden, often believing that if they can continue to crawl into the oncology clinic it will be OK. They are denied the benefits of hospice because hospices cannot afford to pay for the immunotherapy and therefore can not accept a patient who wishes to continue the treatment. Families often report that their loved ones died worse deaths than their animals, and that very little was explained to them. The disturbing trend is perpetuated by a medical culture that is death avoidant, sees hospice and palliative care as a form of “giving up”, “taking away hope”, and seeks to avoid topics that could upset the patient. Just as ethical choices are determined by cultural values, various medical specialties have different cultures and belief systems and may disagree on what is ethical. The oncologist may believe that providing hope is most ethical, while the palliativist will believe that informed choices after a detailed assessment of patient goals and values are most ethical. Who draws a line in the sand? Who compromises and meets in the middle? Close collaboration between specialists is ideal for promoting the most ethical anchoring points to which all parties can agree. Most certainly those anchoring points will align with the four ethical principles that we all learned in our programs of study and must embody on a daily basis.
1. Ventola CL. Cancer immunotherapy, part 2: efficacy, safety, and other clinical considerations. Pharmacy and Therapeutics. 2017;42(7):452.
2. Kirk K. The Development of Hospice and Palliative Care. In: Bruera E, Higginson IJ, von Gunten CF, Morita T, editors. The Textbook of Pallliative Medicine and Supportive Care. 3rd ed. Boca Raton: CRC Press; 2021. p. 1-6.
3. Kuhn E. Why Me?–The Concept of Physicians’ Spiritual Self-Care: A Contribution to Professional and Organisational Ethics. In: Seidlein AH, Salloch S, editors. Ethical Challenges for Healthcare Practices at the End of Life: Interdisciplinary Perspectives. Philosophy and Medicine. 141: Springer, Cham; 2022. p. 55-72.
4. Kyrtata N. Should the Family Be Allowed to Override a Patient’s Decision to Become an Organ Donor after Death? In: Anna-Henrikje S, Salloch S, editors. Ethical Challenges for Healthcare Practices at the End of Life: Interdisciplinary Perspectives. Philosophy and Medicine. 141 ed2022. p. 107-19.
5. Ren SS, Deng JW, Hong M, Ren YL, Fu HJ, Liu YN, et al. Ethical considerations of cellular immunotherapy for cancer. Journal of Zhejiang University-Science B. 2019;20(1):23-31.
6. Ethical and Religious Directives for Catholic Health
[press release]. 2009.
7. Jain N, Tulsky JA. Ethics in the Practice of Palliative Care. In: Bruera E, Higginson J, Von Gunten CF, Morita T, editors. Textbook of Palliative Medicine and Supportive Care. 3rd ed. Boca Raton: CRC Press; 2021. p. 39-46.