 As the founder and president of Fox Ethics Consulting and the founding director of the Center for Ethics in Healthcare at the Altarum Institute, Dr. Fox has worked to improve ethics programs and practices worldwide. As many of you know, Ellen served for 15 years as the director of the National Center for Ethics in Healthcare for the U.S. Department of Veterans Affairs. In this role, she directed ethical programs throughout this both inpatient and outpatient programs throughout the Veterans Affairs Health System. Dr. Fox will be moderating today's panel on informed consent. Please join me in giving another warm welcome to Ellen Fox. Good afternoon. Morning. Good morning. I'm on East Coast time. Our first speaker is Eric Kodish. Rick. Eric Kodish is a pediatric hematologist and a professor of pediatrics at the Lerner College of Medicine of Case Western Reserve University. Previously, Dr. Kodish served as the FJ O'Neill, professor and chairman of the Department of Bioethics at the Cleveland Clinic Foundation and as the founding executive director of the Cleveland Fellowship in Advanced Bioethics. Dr. Kodish served as the chair of the Bioethics Committee of the Children's Oncology Group and as an appointed member of the American Academy of Pediatrics Committee on Bioethics. Today, Dr. Kodish will give a talk titled Parental Refusal of Pediatric Cancer Therapy, Ethical Dilemmas. Please join me in giving a warm welcome to Rick. Good morning, good afternoon. A few words before I launch into the substance mark. They say that ontogeny recapitulates phylogeny and I would say that's been disproved as a biological theory, but during the 12 years that I chaired ethics at the clinic, the model that you set really helped me and I just want to say that publicly. I think I've said that to you privately before, but you really, you know, were the imprint for how I learned. I also, thank you, thank you, Mark. I want to thank Steve Miles for a wonderful talk. I want to say about Bill Meadow, may his memory be for a blessing. And I also wanted to invoke the memory of another Steve back 30 years ago when I was a fellow in 1989, Steve Tullman was with us. And I'm going to do a little amateur casuistry today in his memory. I know Steve Tullman never would be, but I think about him in this topic as well. So thank you. I want to talk about refusal of cancer therapy. We see, I think in medical ethics fairly often an insistence on continued treatment when patients are desperately ill and we see that especially in childhood cancer. Quite understandably, we have empathy and I think we have a set playbook for sort of how to deal with that very difficult dilemma. We're seeing more and more cases, however, of refusal of cancer treatment and I'm not sure we know how to deal with that quite yet. So I want to talk about it and maybe get your help. I want to always, I always go back to Pediatric Ethics as a framework to start out with. I want to think a little bit about whether reasons matter if parents are refusing treatment. What does it matter what their reasons for refusal are or should it? And just to appreciate the complexity and decide which variables are most important when we try to do the right thing which I think is the goal of ethics. Rabbi Jonathan Sacks has a very nice definition of an ethical dilemma. It's a situation in which there is no right answer. It arises in cases of conflict between right and right or between wrong and wrong. Whatever we do, we're doing something that in other circumstances we ought not to do. In such a conflict, there may be a proper way to act and you see his deontological thinking here but this does not cancel out the emotional pain. And I see my colleagues in pediatric oncology having great emotional pain when a parent refuses treatment of a child when the cure rate is quite high. So I think this is a nice definition. This is my picture of pediatric ethics with the child at the top and I think it should help us remember that parents are important, that you as a clinician have an important stake but that the child's best interests or some conceptual model for how to make decisions on behalf of children should really be at the top of the pyramid. So I'm gonna show you a little video now. This is a film by Jeff Weitzman. Fasten your seat belts. And do I just, is it a touch screen? The doctors instill this fear in you. They tell you, you know, if you don't do this, your kid's gonna die and they look you right in your eye and they're serious about it. They said it multiple times. They tell us. So if our child will die, if she stops chemotherapy. His side effects were so extreme. I feared I'll say goodnight to him and he won't wake up again. Raul has been able to bear it but it has been unbearable for me and she shouldn't have to because she doesn't have cancer. Nobody knows that kids are being forced into chemotherapy, that they're being taken away from their parents in certain situations and forced into chemotherapy. 99% of the population has no idea this is happening. There is no cancer for which I would be willing to undergo chemotherapy myself. No cancer at all. You can't say, well, what about this exception? What about that exception? Nope, no exceptions. The substances they use are extremely toxic. You can't just tear down, tear down, tear down and then expect health to flourish from that and damage the immune system. The immune system is what you need to heal. And this lady walks in 100 pounds overweight holding her McDonald's soda from downstairs from her lunch break and wants to tell me how I should be feeding my child. The average editor took from a drug company about $470,000 per editor. And there's 35 of them. It's like, oh, these are the editors who decide what article does publish, they determine who writes the guidelines, they put out the guidelines and they're almost taking half a million dollars each every single year. So then all the evidence that you rely on for evidence-based medicine is corrupt. For a little while longer, but this is a trailer for a film that is apparently available on Amazon. And this is out there. So I just thought that that would set the stage. I've been doing a little bit of pilot work on this and I'm not gonna do the audience poll here because we don't have that much time. But the template is a five year old girl newly diagnosed cancer, 25% chance of cure. And you've done your best to talk to parents to get them to agree to treatment. And if they say no, would you seek a court order at a 25% cure rate? And the exact same scenario at a 50% cure rate. And then finally, if there was a 75% cure rate. And this is a question that I've been asking pediatric oncologists in an informal pilot way. We hope to get some more data about it. I'll show you in general that the response, as you can imagine, is that if there's a 75% cure rate, quite a large number of pediatric oncologists would seek a court order, almost 100%. And it goes down with lower cure rates. And one way to think about that are these three interesting ideas in pediatric ethics for how we should have standards for decision-making. Many of you have heard these concepts at this meeting or other places over the years, best interests, basic interests, or harm principle. And one way to think about this question of what point would you report for medical neglect if you have a best interest standards, which I take to be sort of the highest standard, even a 25% chance of cure might trigger an oncologist to make a report for medical neglect. Rich Miller's work on basic interests, I think, is very informative, more of a middle ground, and if it's a 50% chance, that may map on. And I think, again, this is one of these things where Bill Meadows' memory comes in. It's like taking some data, putting some conceptual work and blending those together. And then the harm principle, if your threshold is there, it might take a 75% cure rate, but most pediatric oncologists would certainly get a court order for that. And here is the data at the pediatric hemonch meeting last year. It was 36% yes and 64% no. If it was 25% chance, and if it was 75% chance, 100% would say yes. In the COG Bioethics Committee, very similar findings, a little bit of a smaller sample size. I'm gonna briefly talk about three papers that I think are important in laying the foundation and have influenced me in how I think about these issues. The first is Jeff Hoard, published a case report of a seven-year-old with favorable prognosis, ALL. The family agreed to treatment for the first three months, the child was in remission. We know that remission is not cure, especially with ALL, which requires two years of treatment, at least. But they opted for an alternative medicine approach. They found a licensed physician in the state of Ohio who was not an oncologist, but did have a license to practice from the state medical board. And that doctor administered alternative medicine supplements. The oncologist reported this as neglect. The state medical board was also notified, decided not to take action. The judge decided that from his or her perspective, two licensed physicians were involved in the parents, should get to choose between two licensed physicians. So a little culpability on our ability to please ourselves, I think, in medicine. But Jeff and his colleagues said an oncologist must act as an advocate fighting to ensure the child is given the best chance of cure while trying to balance the harms that may occur. A second paper that our friend Lainey was on and led by Aaron Talati-Paquette looked at adolescence refusal. And just for the sake of time, I'm gonna get to the punchline, which is when the prognosis is good, the best interest framework dominated. When the prognosis was poor, parental authority dominated when younger and minor autonomy mattered with older patients. So you can see the richness and nuance of this issue, the age of the child, the parental reasons, the prognosis, the toxicity of the therapy, so many variables to think about. And finally, and I think a paper that really got me into this recently, my colleague Amy Cruzo Brown, actually identified 73 unique cases in the literature, published this in Pediatrics, found that 70% of the cases involved legal action. And she constructed a nice taxonomy of four groups of the sorts of reasons why parents refused. She carefully articulated the limitations and said that more research was necessary. And here's the four categories, preference for complementary alternative medicine, faith-based reasons, concern about adverse effects, and parents who had no insight. Those of you who are familiar with the Passover Seder, this is the fourth son, the one that doesn't know how to ask. So, or what questions to ask. But importantly, Amy and her colleague pointed out that there was often overlap. These aren't single reason categories, and this was a nice little figure from their paper that looked at the sorts of reasons. So, a couple ethics points here. One is a point about uncertainty. There's empirical uncertainty, which I think is categorically different from ethical uncertainty. With empirical uncertainty, more research can change it. We can get evidence, and we can decrease the amount of uncertainty we have. I don't think ethical uncertainty ever goes away, and I think it's gonna be an enduring moral question, but the ethics analysis certainly can sharpen the focus, and this is where the casual history is gonna come in pretty soon. I think there's a rebuttable presumption in ethics that reasons matter, but it's not always the case that reasons matter. In my hierarchy way of thinking, actions are what matter most. The reasons people do something is subsidiary to that. And importantly, the way that somebody does something I think is important and often overlooked, the grace, the manner with which somebody does something. So, reasons matter. If the action is killing somebody in self-defense versus killing somebody in the act of robbing a bank, I think we would all say the action is the same, but the ethics are different, and there's moral culpability for doing a bank robbery, maybe not for self-defense. In cases of very curable cancer with young children who can't participate in decision-making, to me it seems like we should say reasons don't matter because it's a five-year-old who can't express his or her own reasons. But I'm eager to talk about it and hear your perspective on whether parental reasons matter. I think a pediatric oncologist who reports a family who's refusing treatment with medical neglect is making an unethical decision, but I think sometimes my colleagues delude themselves and they think that they're making the ethical decision when in fact it's a judge, is a representative of our society who is making the ethical decision about whether to remove custody or not. And the courts are expected to hear arguments from both sides and to act in parents' patriotic. The courts we know are a blunt instrument, however, and parents who refuse treatment, even when the prognosis is excellent, I think we all would agree you're doing something other than child abuse. Child abuse is not a good way to think about this, but it's sort of the only tool that we have. There have been cases where parents leave a child, God forbid, in a car with 100 degrees and the child dies and they're prosecuted. There are lots of kinds of shaken baby syndrome, sexual abuse, physical abuse. This isn't that. I don't wanna contend that, but I think we need to have humility when it comes to our decision-making as pediatric oncologists. Causation is an important feature in moral psychology and we need to remind ourselves that it's not the parents or the physician who gave the child cancer. We know that bad stuff happens in life and childhood cancer is certainly one of those bad things. But we do expect good parents to make reasonable decisions in a zone of decision-making authority that's protected, that's their parental prerogative and to select a controversial comparison where maybe two of them. I don't think there's a groundswell of support for pediatricians to report medical neglect when they refuse immunization for measles. Certainly some pediatricians feel that way and they feel that way quite strongly, but I think the consensus is we don't report that as medical neglect. That's one case. If it's a five-year-old who's having a GI bleed and the parents are Jehovah's Witnesses and the child's gonna die if we don't give a transfusion, I think there's almost unanimity that pediatricians should report that. So how do we think about this refusal of childhood cancer treatment in the context of those two bookend cases? I wish Professor Tullman was here to help us think through that one. So back to the dilemma. In my mind, there are some things that should influence a decision to report. Child's prognosis, the ascent or dissent of the child if it's an older child, including the need sometimes to ask parents diplomatically to leave the room so that we can talk to the older child himself or herself. The burden toxicity length of treatment should not go unthought of. It's extremely important. We had a patient last weekend have a four-hour seizure from a new chemotherapy in a drug that was intended to help the cure rate get from 90 to 95%. So it's tricky, the toxicity is real and we don't wanna discount that. Is it a new diagnosis versus refractory disease versus relapse disease? And parents sometimes disagree with one another, believe it or not. So is there a parental disagreement going on? What factors should not influence the decision to report? I've stated in my case that I don't think parental reasons should matter. I certainly don't think race, gender, SES, nationality, religion should matter and I think that we need to be aware of and actually to study our own biases in this regard and that part of the empirical work I hope to do going forward is gonna look to detect potential bias in which cases pediatric oncologist report and don't report. And I think the resources of particular child welfare system shouldn't affect our decision. Sometimes we hear the county is overburden, they have so many more difficult cases to deal with, they're not gonna waste their time with this one. I don't think that's a reason to not report. That's up to the county once you make the report but I don't think we can tell ourselves that and say okay, so we're not gonna do it. This is a busy slide. I hope that Steve Miles would not say don't show it. I mean, Bill Meadows, sorry, right? There is a lot here but I think it's a good conceptual model that shows some of the things we should be thinking about it. The medical team is influenced by these things, the family is influenced by these things and how do we manage the refusal and at what point do we get the court state involved with these underlying questions of ethical considerations on the bottom. And this is an area that I'm excited to do more work in, to do some empirical work. It's been awhile since I've done empirical research and I'm looking forward to your answers to maybe some of these questions. This is the last slide, I won't read it, I'll give you a second to glance at it. And I wanna give special thanks to some colleagues, Amy Cruza-Brown, Aaron Paquette, Yoram Ungeru and a medical student I work with, Matt Nagy, who have helped me a lot with this. I'll put these questions back up for the question and answer. Thank you for your attention. Do we have questions? Come to the microphones please. Oh, okay, we can show them. I'm Matt, yeah, I put some medicals in and so the, I understand the hierarchy of, you know, the action is greater than the movement, but I think the thing that you can run into is if you support shouldn't matter because it's off from the, one of the talks yesterday about how different countries are ethical values are so different. So to what extent is choosing to report without regard for reasons and in position of your own cultural values on this situation? Great question and I agree, it was a wonderful talk yesterday and it got me thinking about this talk as John was talking about that. You know, I think it's not an imposition. I think the idea that it's an imposition of our cultural values sort of minimizes the fact that there is heterogeneity. If this was a case in India, I wouldn't be, you know, banging on the table and saying we must report or at least that we must make guidelines. I appreciate that culture, I respect it, but we operate in this culture and I've given up on a universal ethic. I just, I don't think it exists and I think we need to be thoughtful about our own standards and certainly learn from other countries, but not allow that to throw up our hands and say let this child die. Hi Naomi Laventhal, University of Michigan. I'm thinking about your fourth bullet point here about consensus among oncologists. And I guess I would say the answer to that question is yes, but I'm curious about, from your perspective as a pediatric oncologist, so it seems like the principle is clear, but the process is elusive and I wonder if you could say a little more about that idea. Thank you for asking that. This, we've mapped out a process to develop consensus guidelines that involves parent stakeholder input and I think my conversations with leadership of the Children's Oncology Group and ASFO, the pediatric Heman Group, that our colleagues would welcome some sort of consensus guideline. We've done this before when it comes to assent and I think that's been a helpful thing. So I'm hoping that we'll get on the same page and that it'll help to at least mitigate, not eliminate, but maybe mitigate the risk for bias in those decision making processes. Yeah, thanks. Let's take one more short question, please. Thank you for this important topic. You mentioned that one of the factors is religiosity for parental refusal. One of the factors is parents' religious belief. From my experience, it's mainly misinformation that the parents get, especially when they come to cancer or autism. From the Islamic Park specific, I always tell the people when I'm getting involved with the community that Islam teaches that when there is a proven cure, you must see the cure. If you refuse the cure, you are committing a sin because there is a proven cure. So as far as Islam is concerned, parents shouldn't refuse treatment when there is a proven cure for that treatment. Thank you. That's a really great comment and I think you find that certainly in Judaism, you find that. But in some of the cases that I've been consulted about and asked about, the parents have a particular religious authority that they're turning to. And the trick, as a clinical ethics matter, is to get them to listen to other religious authorities and then that moves on a little bit to maybe an imposition of cultural value. So you do have to be careful, but I think showing respect for that parental religion and that faith view is a really important first step in trying to get to some compromise, potentially. Thank you. Thank you again, Rick.