 Our next speaker will be Dr. Paul Helft. Paul is the director of the Charles Warren Fairbank Center for Medical Ethics and an associate professor of medicine at Indiana University. Paul is a member of the ethics committee there and co-chairs the ethics consultation subcommittee. Paul completed, you did your bachelor's here too. Oh, yes, I thought so. His bachelor's degree, his medical degree, his residency in internal medicine, his fellowships in hematology and oncology, and his fellowship in clinical medical ethics at the University of Chicago. Paul, welcome. Welcome back. Thank you very much. It's really fun to be back. So thanks to Mark and to the whole center. And congratulations on all the obvious accomplishments. I'd notice that just in my own session here, session two, Lynn Janssen was a classmate of mine from fellowship. Alexia is one of my closest colleagues. David Rubin was one year ahead of me in both medical school and in residency. And Ellen was either a senior fellow or a junior faculty member when I was in medical school here, so the connections go deep. This is on the subject of random topics. This talk is a set of opinions I've come to over the course of the past one or two years watching a number of mostly regulatory efforts, including in my own state of Indiana, to impose the use of opiate care contracts for patients receiving opiates for mostly for non-malignant pain, although there have been many discussions about populations to involve. And so just briefly, in terms of background, what I'm going to call written behavioral agreements were actually first used in the late 1960s in the context of no suicide contracts, as they were called at the time. And then since that time, they've developed a utility in psychiatry and in pain medicine and in addiction medicine. And the recent, what has been called an epidemic, which I think probably could be described truly as an epidemic of harms from prescription medications, mainly opiates have made them more popular. And as I mentioned, many state regulations have begun to require them. So just to convince you how serious the problem is, the number of deaths from unintentional drug overdoses has been rising steadily for two straight decades. It's now the second leading cause of accidental deaths in the US. And overdoses of opiates now outnumber those of heroin and cocaine combined. And I think very importantly, the toll that this takes not just on patients and families, but on providers who interact with what I think can only be described as this extraordinarily challenging and difficult group of patients leads to a great deal of frustration. So ask any primary care internist or resident in a resident internal medicine clinic. And this becomes a real major issue. So I just want to acknowledge that I recognize that. So here's the argument that I'm going to try to make to you over the next 10 minutes. I'm going to argue that opiate written behavioral agreements should be abandoned. The argument flows from three contentions that, again, I'll try to convince you of. The first, that there's no compelling evidence that they achieve their desired outcomes. That is, they're ineffective. Number two, that they're analogous to adhesion contracts in the law. That is, that they're unfair, lopsided, and might be described legally as if they were legal documents as unconscionable. And that finally, they fundamentally alter the doctor-patient relationship in harmful ways. So again, these written behavioral agreements started life as contracts. And when people became uncomfortable with the term contract, recognizing that they were, in no way, actual legal contracts, came up with the term agreements. And I'm just going to use the term written behavioral agreements, which is not in the literature, but which is a term that I've invented because I think they best describe what they actually are. So let's talk about the effectiveness of opioid written behavioral agreements. So the goal of these agreements purportedly is to increase adherence to the medications. And I'll just review the literature with you about what the outcome studies show. The Cochrane Collaboration did a review published in 2009 looking at 30 randomized controlled trials in the areas that you could read there, and concluded that there was not enough evidence available to recommend the routine use of contracts and health services to improve patients adherence. And Starles did a review, the largest review that I know of, looking at this issue in pain management, looking at 11 studies, they were all of sort of fair to poor quality and found only relatively weak evidence supporting their effectiveness in reducing opioid misuse. These are two smaller studies. From 1995, a small retrospective observational study found a small positive effect on adherence. But actually, when you look carefully at the study, there were no explicit outcome criteria defined in the study, so it's very hard to know what they actually meant. And finally, in 1996, this case series of 20 cases of patients with non-mulligan pain and actually a history of substance abuse and found no correlation between assigned agreement and subsequent abuse. So difficult to draw conclusions from such small studies. But again, I haven't been able to review all the many studies that have now been reviewed in the Cochrane review, but I would argue that the conclusion that we can draw from a broad level are that no high quality data exists to support such widespread use and endorsement by practicing clinicians by professional societies now or regulatory bodies. So some have tried to argue that these documents are not actually contracts or agreements. What they actually are is informed consent documents or educational documents. That is, they serve those functions instead. And I won't belabor with this audience the four elements of informed consent, but this is the largest review that I know of looking at pain documents from 39 major academic centers in which the authors analyzed every statement that was contained within the documents and grouped them into 12 major categories based on their frequency. And if you just read through the list, what you find is that 90% of the documents contained the terms of treatment, prohibited behaviors, points of termination, and so on and so forth. Again, I won't read the list, but I think it's fair to say that hardly any of these pertain directly to either education or to informed consent. Now I want to turn to, as many of you know, I'm not a lawyer, but I think it's important because these documents started life as contracts to conceive of them for a moment as contracts and see what that outcome would be if you used a legal analysis as a lens. So these are clearly not legally binding contracts, nor is it likely that they were ever actually managed to function at such. However, I would contend that proponents of these documents believe that they must serve at least several of one pseudo-legal functions. They might be serving to make patients' obligations of the patient explicit to specify the consequences of non-inherence to allow a pre-specified means of exiting the relationship or to provide some protection from legal risk. These documents may actually, in that respect, more closely resemble adhesion contracts rather than legitimate contracts, and I won't read to you the Black's Law Dictionary, but definition of this. But I think the important parts of it are that the party signing it is in a weaker position, usually a consumer has little choice about the terms which is generally universally true about signing opiate pain contracts. So if they were contracts, they would probably be unenforceable because they would meet the legal definition of unconscionable, that is leading to an absence of meaningful choice on the part of one of the parties together with contract terms which are unreasonably favorable to the other party. And so I conclude from this that they are both unconscionable and unfair, analogous to illegitimate adhesion contracts because they force patients to sign them under duress with a lopsided set of expectations and requirements, and they may or may not provide any legal protection by virtue of their role in documenting attempts to control patients' behaviors. This latter issue has not been well studied at all. So turning to the third point that I tried to make, I'm trying to make, the ethical risks of written behavioral agreements. The pain wrote in 2010 that the main function of these documents appears to be to control or modify a patient's behavior. And in fact, in Fishman's review article that I just cited to you, nine of the top 10 most frequently identified statements in the contracts analyzed were statements requiring specific behaviors of patients. So what effect do these have on the doctor-patient relationship? Well, with their legalistic and sometimes punitive language, they're likely, I would argue, to undermine trusting doctor-patient relationships. And in fact, may indeed transmogrify core elements of the relationship which contribute to trusting relationships. Think of William May's idea of the relationship as a covenant, and you'll see that a document that tries to outline this part of it doesn't fit into that well at all. So you might ask, what is the real purpose of these documents then? And so I've come to the conclusion that the real unstated purpose of these documents is actually to provide a defensible exit strategy for from the relationships, which again, I don't want you to think I don't understand, represents some of the most challenging and difficult patients in any medical setting. So patients with chronic non-malignant pain, patients with addiction and severe behavioral issues, et cetera. And so reliance on these documents represents an abdication of our deepest ethical commitments. It may be easier to use these documents as a grounds for dismissal than it is to provide long-term seemingly ineffective, frustrating, challenging, interminable care to difficult patients. But again, I would argue that they do the kind of damage that does not justify their use in existence. So in conclusion, you might ask, what are the alternatives then if I'm arguing for abandonment of the documents themselves? Well, I think we go back to the core fundamentals of the doctor-patient relationship to include caring, open, and I'm not saying this is easy, by the way, caring, open, honest, and compassionate communication, detailed informed consent processes, which are then carefully and extensively documented in discussions, good luck with all that, right? Setting limits, even including refusals to provide certain requested treatments without, that don't rely on a contractual basis. And the ongoing provision and promise of care, clinical encounters, and even alternative therapies, that is an ongoing relationship, which may or may not include the prescription of opiates in that relationship. Thank you. Great, there's time for questions for Paul. Yes, please, oh, wait, oh, I see a lot of hands up. There's one over here for us, Mark. Elizabeth and then over there, go ahead. Those are really good questions. Briefly, I mean, I think this paper actually started life as an argument about all written behavioral agreements, including no suicide contracts. There are even better data to suggest that those are not effective. So it's very true, and I think two things are at work in the first part of your question. One is that we have an inadequately trained, as a primary care group, as those specialists who deal with patients with respect to difficult psychiatric and behavioral issues. And the second is we come to it with a great set of biases actually against both addiction behaviors and the difficult patient behaviors, et cetera. So those, I mean, those two, I think both have a profound effect on the problem. We're gonna take three short questions. I see three people standing up, and then give Paul the chance to answer all three, Dan. Yeah, Dan Bronner. Nice talk, Paul, I agree with you. You were my attending, remember? Yeah, I remember. So I think you bring up a great point, and it seems, you know, we don't have those contracts here, but we have other ways in which the government is trying to make it more and more difficult to prescribe opiates. You know, you have to have a handwritten thing. Oh no, I don't. I haven't yet. Yeah, but anyway, so may I will in the future. But it seems that these things are not really directed at sort of improving the patient's lot in life, that it's just ways of getting in the way of prescribing the drugs, and that they're really a subterfuge to the government's plan, which I think it's important. I think people are using pain medicines at this point in ways that are, you know, they're way over prescribed now, especially in emergency rooms. For some patients, obviously, who use, that people are using sort of a hospice model with patients with chronic care. But I think part of the issue here is that they don't really care that much that they're effective at patient care. They're just roadblocks to getting a prescription to the patient. Yeah. Thank you. Ellen, a brief question. Hi, Ellen. My question relates to your recommendation about informed consent. We actually have been dealing with this for years, and I think finally may have solved it, although the new policy hasn't come out, but, you know, what I'm advocating for is we're actually gonna ban pain care agreements and require written informed consent, very similar to your recommendation. But I wanted to ask about, you know, you suggest that it relates to an exit strategy. And actually, in our system, there is no exit strategy. Right? It's not, that's depth, and it's clearly not the intent, because we can't fire patients. And so it's much more about a belief, I think, that it improves safety, which there is no evidence for. And so I was wondering, you know, I was thinking of a variety of questions, but my main question is, you know, what we ended up with in informed consent was language about the limits. And patients have to say, the language is, I have read this patient education brochure about safety, and I intend to do what it says in there. And that is as far as we go. And I was wondering what you would think about that. Well, I would just ask you a simple question. Who is that document for? It's clearly an education document. Yes, it's very patient-friendly education document. No, it's clearly for the institution and the practitioners to protect them. I disagree. I disagree. We have written informed consent for many, many, many things that you probably don't, and we use it clearly as education. But your written informed consent documents don't set a limit. Yeah, they do. I would say they do, because they clarify what you're expected to do and the consequences if you don't do those things. It's an educational piece, right? So if you, we could get in a whole debate about this, but if you, if it's unsafe, if it's unsafe, I think you need to inform people. I have no problem with providing educational documents. But turning them into, you know, so-called sort of enforceable agreements is where, that's where I've got to go. I would argue that ours isn't, but I don't, I think you might think it is. Yeah, I think it is, certainly. Well, I would agree that the relationship is, what I'm arguing is that the relationship and the standard practices within the relationship are sufficient. That this is actually a net harm on the relationship. That kind of goes with what I was gonna say in that briefly, pushing back against Ellen a little bit. There is a time, therapeutic doctor-patient relationships are relationships, and there may come a time when that relationship is no longer therapeutic or functional, when certain lines have been crossed, whether deception or mutual or unilateral deception. So certainly those lines can be crossed. Perhaps these documents, I would agree with you, are not a way to measure whether or not that line has been crossed. Thanks, Dennis. Thank you very much both. Thank you. Thank you so much.