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.
8 thoughts on “The Ethical Perils of Immunotherapy: Medical Care or Extortion? ”
Thank you for sharing this story Leah. This October will be 5 years since my mom Norma’s death in AZ. Reading this brings me to tears. I am saddened that she was so uninformed about her disease. She also had a subclavian port placed by CV surgeons for anticipated treatment (Keytruda) which was never used because I arrived & intervened in her care. She paid $500.00 co-pay for that procedure. UGH! Keep up your good work; people need nursing advocates!!!
Linda Kowalczuk, APRN, ANP-BC
So sorry that happened, Linda. She had a good outcome because of an awesome daughter.
Thank you for this article. I admit I read with increasing horror and a growing knot in my stomach, to the point where I almost had to stop. Then came the disgust, and the increasingly repetitive feeling of sheer incredulity I feel on a daily basis when looking to “the greatest country in the world” (self-described).
Two issues are snaking up through the words in this article. The first, most horrific, and obscene one is the lengths to which capitalism has destroyed the US. Harsh?
I live in Australia. I work for a Community Palliative Care Service. We generally accept patients who have roughly a 6 months prognosis (who can really say, right?). We accept pts and families who may only need psychosocial support, we regularly discharge patients and may admit them at a later date if required. We will visit daily if required. We have a team of general community nurses who will conduct stable palliative monitoring, and visit daily as needed. There is access to OTs, Speech pathology, Exercise physiology, breast care nurses, social work and counseling, Specialist Palliative care physicians and NPs for consultation. This service is offered regardless of whether a pt is receiving treatment – they often co-exist, and we even have a model that illustrates this blend of PC and “curative treatment”. And apart from some nominal fees for visiting nurses (eg $7/wk) this service is FREE. ALL FREE. No one has to bankrupt themselves. No-one has to rationalize their lives away or die in abject poverty. I simply cannot fathom the pervading existential distress that you must experience on a daily basis, living without health security. And now to read about the financial rorting and exploitation that inevitably exists when you try to privatize a basic human right.. well, it’s sickening.
My husband received effective, life-prolonging treatment at $17,000/month for 10 months, then 3 rounds of immunotherapy without paying a single cent. He even had his end of life medications paid for by the Pall care service.
I am sorry you have to go through that, but the worst thing is that, as I’m sure you know, it is totally unnecessary.
My heart goes out to you all.
The other issue raised is the increasing lack of health literacy within our general population. You have no monopoly on that I think. It seems to be all-pervasive. Not only health literacy but death literacy. I believe that for every person IN a bed in a hospital, there needs to be someone at the END of the bed, looking out for them, asking questions, advocating.. Patient advocacy has never been needed more, as treatments become more and more complex and confusing, coupled with the denial of death we see on a regular basis. I love your term “non-goal concordant care”.. it almost pokes fun at the medical gobbledy-gook, and shoots back with a polite but firm “no thank-you”!
Here is where the end of life/death doula/midwife role could be so well utilized. People who have a passion and commitment for “goal concordant care”, for ensuring quality over quantity and helping their clients to explore questions of mortality, legacy and what a good death really looks like for them.
Phew. That was a bit of a rant! Sorry!
Again, thank you for the article. I can’t imagine how difficult it is for all you practitioners operating in such an environment. All power, love, and respect to you.
My mother chose to do immunotherapy. No one in the family put pressure on her. She is already more than a year into immunotherapy treatment. I believe she was the first patient or one of the first on the treatment she was started on as that form of immunotherapy was approved last summer. I believe they even tested her tissue with it before she started. It showed she should have success with it as I remember correctly. Doctors should be forthcoming with how serious things are and what the likelihood is they will live 6 months, a year, or 2 plus years. I think she actually is doing better on this health-wise than she did with radiation and whatever else she was on, They wanted her to do chemo again, but she had such a hard time with that she said she would never do it again. It should be on option out there for those who want it.
Of course she should, I wouldn’t imply otherwise. I just don’t like the lack of teaching and assessment of patients goals, wishes, knowledge that leads to uninformed choices. Your mom looked good last I saw her, I pray she does well for as long as possible and is able to spend time on meaning activities such as visiting with you.
I understand what you are saying. She has had more energy that last two times I saw her. Doctors should be upfront with options and chances.
Thought provoking piece. It is a deep challenge to weigh the values of a patient often compounded by the fresh and pressing nature of decision making that often comes with a cancer diagnoses. I see patients in the inpatient setting. An added challenge I often encounter is the oncology note that reads, “will discuss treatment options in outpatient follow up.” I wish I could read or hear the language used to present the option of immunotherapy. I try not to be biased by the return admission of patients with complications of immunotherapy or progression of disease. At a minimum, treatment should not be initiated or offered if time to potential response exceeds apparent life expectancy. I fully acknowledge that prognostication is not an exact science. As I said, thought provoking.
This is so touching Leah thank u for such a amazing article, i totally am baffled by all this. years back i lost both my parents in the 80s from cancer then it was much different, treatments etc however it is very true that drs need to be honest and forward with information to their patients i know science has come along way since the 80s. but there are so many clients i have taken care of being a cna, that have been misdiagnosed & found out it is to late until patient is on hospice. What is the right thing to do… in my opinion its always honesty and drs should always let patients know sometimes the suffering is way worse… with treatments that are just making u more miserable with the disease, hard on families to watch also. thanks for all this wonderful knowledge & wisdom u truly are needed!!!! Kim T