 I'm fortunate again to host and be enriched by Dr. J Jacobson. Dr. Jacobson actually left clinical practice in January of this year. So both congratulations and congratulations all at the same time. He has held dual appointments both in internal medicine and infectious disease and also in ethics. Oftentimes we've had collaborations between our chief residents and Dr. Jacobson. This is one however where it is this entire circus. So we won't be burdened by having to have a resident along for the ride. Just kidding residents. With that, again thank you, thank you for coming and sharing your expertise with us Dr. Jacobson. Thank you. I appreciate Jeff's comments. This is a very attractive venue for someone like myself. One of the reasons is that given his allusion to residents something you remember is that everybody comes to a presentation with different perspectives. And I think your program is especially interesting to talk about ethical issues in because you have people in training who haven't yet fully sort of felt the weight of responsibility on ethical issues, experience and perspective are terribly important. And I was mentioning that you have both people in training, people in academic practice, but you also have people from the community. And one of the things that's characteristic I think of ethical issues is they really change depending upon both your prior experience and your position. That is you see different things and you see them through a different lens if I can say that depending on your experience. The last thing I would say is that some of your faculty who I understand will be joining us in about 20 minutes or so often have a very strong interest in these issues. That seems to be more true of your department than some others. So for all of those reasons it's actually always a privilege and a challenge to come and talk to you. So today you saw the title of the lecture on your handouts. It's disclosure of conflicts and errors, which is harder and which is more effective. I'll just tell you at the beginning that because this will be kind of a partnership and interactive with your thoughts and things that I've put together, we may or may not get to the second of these conflicts today. And that would be fine. We can do that in another day. But my goal I think is to get us all thinking hard about conflicts and how we manage them. Because there are conflicts of all kinds that arise in the course of our careers. So the first word of that title is disclosure. So one of my questions for you is in the last six months have you been asked to disclose something in any environment, in work or anywhere else? Sure. Can you recall what it was? Just speak up nice and loud so everybody can hear you. I have the mic. So that's the first and I think excellent example of something that can happen in medicine. And you might even want to think about whether that's always been true. If I can repeat your comment, it was if I have a complication and I'm assuming you're talking about a medical complication, maybe in the course of a procedure, if you are the one who knows it but others don't already know it, then you feel this burden to disclose, right? If everybody knows it at the same time, that's not the same issue. Do you think that that's always been true? We're here in medicine and his comment actually is about the second area that we were going to talk about today. It isn't clear, is it, that because there was a complication there was an error. Can we agree with that? And if I heard you right, what you were asked to disclose was the complication. Fair enough. Another term for that sometimes is adverse event. And those of you who do surgery, I think think about complication. I'm more in medicine and I give drugs, right? But every now and then I see something that's really awful. You might call it a complication, right? They both share something. Neither one was intended. But a fair question and you might want to answer it. Do you think in my training as a resident I was required to report adverse events that I was responsible for? Not as frequently what? Finish the sentence? As reporting as frequently? Well, I think, first of all, I think that's right. And I would just tell you that I don't think I was expected to report it at all. One of the things that's really interesting about difference in medicine is, have you had a morbidity and mortality conference? How often is it? Quarterly. I will tell you that some of the internal medicine residents now have it monthly, but that's new. So again, just a difference. Surgical specialties have been committed to things like mortality conferences for a very long time. It didn't really sweep across all of the medical specialties and ours is kind of a late arrival. So let's just run that out a little bit further. So you're expected to disclose, right? What's the purpose of that? Why did that exist? Why would there be a place where, and we need to solve this, not solve it, but be sure that it's not just the residents that are required to disclose, but why would you have a conference or a place where you'd oblige physicians to disclose and I'm going to keep using your word for a while, complications. What would be the purpose? So the comment is if there's a systems-based issue, and I think the assumption is we might discover that and then if we discover it, maybe we could take steps to prevent it. So a couple of things that are just fascinating. The word systems is a very new word in understanding complications and errors. It starts maybe even around the 90s. Before that, you might even want to think about it. If the idea of a systems problem didn't exist, what would be the purpose? Let me just affirm what you said. I think you're absolutely right. But if you think about it, understanding a systems problem might actually take more than just the resident disclosing a complication, right? What else would you need to do? You really would need to go deep down. For example, figuring out a systems problem is actually very difficult. A much easier solution, actually, is just to blame the person that you think is responsible. I mean, that's really quite efficient, right? It's like we're done here. You disclose that it's a complication. Don't do it again. And that feels like you're finished. But that wasn't working very well. So your comment about systems, actually an acknowledgement that a system that was operating for a very long time, and again I want to give credit to the surgery colleagues, they've been doing morbidity and mortality for decades, but it wasn't fixing problems necessarily to just blame somebody. A further problem with that is every complication doesn't necessarily mean an error, does it? Can you think about the last complication you needed to disclose? Can you share what that was? Sometimes those are pretty unpleasant. If you don't want to, that's fine. But if somebody has an example, it would be great. You dropped a lens. So there are a lot of names for that, right? That could be called an accident. There are just many terms for that, but you felt obliged to disclose that. Sure. Do you think that could have been part of a systems problem? Yeah. Well, if you want to think about a horrible error, you could think about something that you don't do, but I'm sure this does happen to you. Let's just talk. Some of us work in fields where there's bilateral symmetry, right? My nephrology colleagues, pulmonary colleagues, not my cardiology colleagues, right? My ophthalmology colleagues and ENT colleagues, right? You have two sides of the body that look pretty similar. So there's something that now exists in medicine called wrong limb surgery. So you know exactly what I'm talking about. And I'm sure in ophthalmology, there must be wrong eye. So that might be an extreme example. And actually the hypothetical that's in one of the references we're going to talk about is not about dropping a lens, but maybe if I can stretch the language, it's dropping the lens into the wrong eye. Can you see that happening? So there again, there would be this question about you're obliged to disclose. Oh, by the way, who do you need to disclose to? I'm picking on you, so let me just see if there are some others. So other residents, since we're a little heavy with residents today, you can help me understand that. So he shared an obligation to disclose what I could call his words, complication, accident, adverse event. They're all kind of used somewhat interchangeably. Who do you disclose those to? By the way, this will go longer if you don't volunteer. So again, I don't mean to pick on you, but you can answer that question. You had to do the disclosure. Who did you disclose to and was that it? Was there anyone else you needed to disclose to? Tell us. Fair enough. So that had a lot of disclosure with a lot of different listeners and parties. Other people want to go just sort of think about his situation, think about it in your life, and maybe again, this is where perspective might help. If you trained some time ago, I'd like to hear whether you had the same obligation to disclose and particularly want to hear to whom were you obliged to disclose. I'll just take advantage of your story. Your story is partly situational and contextual. It's actually a very important one. There were a lot of people present. Were they present during the accident or after the fact you were talking to them? So again, these are very contemporary stories. Just think about this part. So his comment, this is a surgeon speaking to an internist, and he's saying the patient is awake. So if you take the long lens of history, surgical patients were always awake for most of surgery. That didn't change until late 19th century, early 20th century, where anesthesia became the norm. So that's actually pretty important, and I'll just underline that, that for most mistakes that occur during surgery, the patients don't know. Can anybody have a different take on that? So one of the things, and again, your field might be very interesting to talk about, because in ophthalmology, more of your patients are awake more of the time. So the idea that he's sharing about disclosure is a fascinating one. Does the patient know immediately that an error has occurred during surgery, an awake patient? What do you think? I don't think the patient knows. Why do you think that? So can you all hear? I have a microphone, but can you hear the comments or should I repeat them? Okay. So the comment was, and it's obvious, isn't it? If the patient is asleep, they don't know. I mean, that would be a given. His comment was, even your patients may not know because they may not see, right, what's happening. I mean, you could be at the part of an operation where they really don't have much vision at all, and you know what's going on, they don't. By the way, you know the significance of what's going on. They don't. They just underline that. That is, this idea of complication adverse effect, unexpected outcome. Here's another term, poor outcome. So you just want to think now in your field, somebody has a poor outcome, but something happened during the procedure. His comment was they might not have even known what happened. I'm going to add they might not understand what happened. What's the clue to an awake patient that a mistake might happen? I think so. And I appreciate you're doing that. My prepared response was, oops, but they actually, and for a really bad mistake, you don't need to say that, right? It's another four-letter word. But that's actually a clue to a patient that something went wrong, fair enough, but they don't know what, and they actually don't know what the significance of that is. I mean, I know surgeons who might say that if the wrong OR tech came into the room, right? Somebody that they hadn't been used to working with. Maybe they had a relationship with the other OR tech. I don't know, but they could be, that's a mistake or something that bothered them, but has zero significance probably for the patient. So they don't know, but that's pretty alarming. The other one is, do you use Versed or anything that would make patients amnesic for the procedure? You're nodding. So you want to think about that. So for you in your field, not in mine, we don't anesthetize people. We give them any hypertensives. But in your field, even in a case where the patient might be aware that something amiss has happened, A, they might not understand what it meant, and B, they might not remember it. So that's actually a very important thing. I'm going to digress now. We're going to go away from this idea of disclosing medical errors because my real point was just getting the idea of disclosure and maybe obligatory disclosure. So other people, I wonder if you can help your colleague here who's been carrying a lot of weight. Have you been asked to disclose something in the last six months? And just to help you think about it, you mentioned filling out a form, right? So have you had to fill out a form that requires you to disclose some information or has somebody asked you a question that you felt obliged to disclose to? I need a little help. Nick? Yeah, tell us, Nick. So again, do I need to repeat that for this side or did you hear Nick pretty well? Okay. Have you ever been accused of speaking softly? Well, actually, that's a good reminder to me. I have a microphone and you don't. So both for me to hear you speaking up is good, but for your colleagues, it's really important. So please think about that. So Nick has made a couple of points. He's referred to a form which needs to be filled out. So sometimes we disclose to a form. Who reads the form? Sorry? Dr. Warner. Warner? Okay. So there's actually, we'll call it an institutional representation, a committee or a person that has responsibility. So ultimately, that disclosure is going to some different directions. And Nick's point is a fascinating one about the family. And I hear a couple of different things in that. One is just addressing the technical, the problem of a drug and loss of memory. But patience and loss of memory is actually much more important than just for said, right? Even a person who was awake during surgery that was painful, can you imagine? If you roll the calendar back, somebody that was having an amputation without anesthesia, at some point they may have passed out. And the last thing they were doing was listening to what people were saying, right? I mean, that's horrific. A minor version of that is just somebody who is terribly stressed by their surgery. They're upset. They're preoccupied. They're worried. They can't listen well. And they certainly don't remember well. So the idea of talking to the family or disclosing. Here's just a fascinating present conflict for you to think about. We have lots of new rules in the 20th, particularly 21st century about privacy. So here you are talking to somebody other than the patient about something really important that just happened. And it's only now that somebody would think, well, do you have permission to tell that person? I'm not taking a position on that. I'm so used to doing that that it doesn't occur to me. But just when you think about rules and regulations, there are new rules now about, for example, a family member who calls to ask about the results of the procedure. And they may have to go over several hurdles before they can hear the answer. So again, just to underline what Nick had to say, he thinks about the timing of disclosure. He's thinking about who and he has a reason. If I understood it, the reason to tell the family is actually very patient-centered. It's the patient may not remember, but the family member will. So you've actually advanced the idea of talking to the patient or disclosing, fair enough. Well, it's fascinating to me that we're talking so much about disclosing errors. And I'm also surprised that I didn't hear anybody talk about a requirement to disclose something else. So I'm kind of probing, and I just want to tell the residents this is one of those experiential things. Residents are less frequently obliged to disclose what we're going to talk about next than faculty. So I need the faculty to help me. So if you see me smiling, it's because that's what we're going to talk about. It would be not just disclosure. It's the second part of the title, right? It's disclosing conflicts of interest. And so new faculty members, again, that's a transitional zone. Going from residence here, fellowship. It's kind of new that you're asked about that. The residents want to comment on why we don't seem to care as much about your financial conflicts. Fascinatingly enough, they do have them. They know this, but we don't call them financial conflicts. I will just tell you as an internist in a field that's called a cognitive field, one that is poorly compensated compared to others, I actually worry a lot about residents and student loans. So it's financial, but it's in the opposite direction. When it's the faculty, we're asking about money coming in, right? That's really the issue is who's paying you we want to know. With the residents, we rarely ask you, how much do you know? But I just want to underline, it's a conflict. It's a conflict that you faced as a medical student when you were trying to decide on which field to go into, right? You had a passion for a particular field, your attendings told you to be great. If we like you, the way we tell you that is we say you should be in my field, right? You've heard that, but you couldn't just easily decide on any field. There were factors, there are many factors, but one of them may have been an enormous student debt. Are you with me? So that's actually, there is a conflict of interest for some people in a very junior position, but we focus as you discovered on faculty. So you had to fill out a form and talk about conflict of interest. What did you need to report on the form? So this is already really interesting. You're the same person that talked about systems and errors, right? That's very new. Do you think that physicians in faculty positions have been asked for a long time about the stocks they own or what their wives or spouses own? No. Nick, I don't think when you first came on the faculty you probably had to do that. Do you recall? No. Thank you. Keep going. So I think Nick's comment included daily. So I was trying to be careful and I asked you originally if in the last six months something like that. But if you're a busy faculty member and I think you ran a pretty good list, you're going to be asked to disclose. And what you're asked to disclose, just to remind you, this is different. As a resident, you were asked to disclose a complication. The faculty members are asked to disclose a lot about their finances. Is that fair? A lot about sources of income and payments. And the first comment even mentioned things like stock ownership. That's pretty interesting. And then the next one that you talked about was your family. So just if you don't know this and the faculty members do, isn't that fascinating that there's somebody who's asking you to disclose incredible amounts of detail. And I think Nick made the point. Not only things that seem immediately relevant to the paper that you're submitting or the abstract, but a little bit more global than that. I'm not sure he mentioned the span of time that they were inquiring about. Do you recall or anyone else? Is it lifetime? Nick says a year. Were you commenting? I said 12 months. So 12 months. There is a group called the sort of the committee of editors on medical journal publication. They actually have one of the very long forms that Nick may have alluded to. And many journals have agreed to use that standardized form. Their form is three years. So again, just for you to understand the magnitude of what's being disclosed, it's a financial interest, compensation or equity or ownership interest of you and your immediate family for the past three years. And the guiding kind of instruction is if you're not sure if it's relevant, you should disclose it. So there's even a leaning in that direction, which is if you don't think it's relevant, let us decide. So I think we're kind of ready to get underway. So Nick has made the point that other faculty members disagree. Any of you think that he's exaggerated? Okay. Any other faculty members that have encountered disclosure that want to add something? Okay. So it's a lot of disclosure. And the question is if disclosure is the solution, and let me just say it's thought to be. That's actually why the editors of all the medical journals got together and said we will require this amount, this level, these specific things to be disclosed, right? I mean, they thought there was a problem. Your revealing complication might be the solution to a problem. Your colleague actually said it might help identify a problem, a systems problem, right? It could identify a problem in your own training, by the way, right? You hadn't been trained up enough to do that properly. And by your telling us about it and our asking questions, we can figure that out. And we can work on your training. Fair enough. So what is the problem that disclosure, and we can focus now on the kind of disclosure Nick is talking about. By the way, just to underline that, see if Nick wants to correct me. I heard to the journals when you submit to a national meeting, if you're submitting an abstract, right? Or a presentation. Who else, Nick, did you find daily you needed to disclose to? There's more. Go ahead. Publications would be the journals. How about within your own institution? If you do a study, you have to fill out comparatives. So this is the IRB story. And again, for those of you that, you know, are interested in when this all started, there were no IRBs before about 1975. So that was not a part of what faculty had to do before that time. And in 1975, there were no requirements to disclose financial conflicts. Just so you know, all of that began pretty much in the 90s. And it was a response to a problem, but we haven't really talked about what the problem is yet. So help me out. Why do you think the people who make these rules make them, and what problem are they trying to solve? Sorry? Trying to eliminate bias. Bias. So that's actually a pretty important word in science, right? If you do research, aren't you trying to eliminate bias as well? So eliminating bias. Somebody want to say a little bit more about that. It's fascinating because this is financial conflicts of interest that we're focusing on. So what kind of bias are we worried about? What were they worried about? What would the bias do? By the way, would you admit or agree that all of us have some biases of various kinds, right? And the goal of eliminating them is really very challenging. You're saddled with an interesting term in research, right? The ophthalmologist I work with always want to correct me when I talk about double-blind studies. But double-blind studies are our effort. By the way, that came from science. Just so you know, that's not outside. But that's a really good example of scientists trying to solve the problem of bias. So we do that by masking people in a study, which is our control group, right? In fact, we want everybody to be unaware of what's under investigation. Whose bias are we trying to address by that? Sorry? Name them. Who is the everyone? So it's a lovely point because when we talk about problems and solutions, so there's a solution to a problem. Investigators recognize that if patients know they're, quote, on an active drug, we know this in the clinical world as well, right? I mean, this is not strange information. If you're given what you think is an active drug by a trusted professional, you're actually already biased to believe that you're doing well. And I'll just tell you there are a few reasons for that. One is you start that experience with hope, right? You want to do well. And if I told you that you were on a drug that didn't work at all, I mean, I pretty well crest your hope, right? So I don't, in a way, I don't even get the advantage of that bias, right? As a clinician, I wouldn't do that. I have very little inclination to say to a patient, I'm going to give you this drug that almost never works, which would be the truth for some drugs in some conditions, right? Some oncologists who are treating lung cancer could say, I'm going to give you a drug that saves lives about 5% of the time. But that's not what they say, is it? So they say, we have a drug for that, and patients feel better. So we have patients who, by the way, also want to please the investigator or the clinician. So I ask you after I gave you the drug and I spent seven minutes with you, which was two minutes more than your last doc, right? You owe me. And I say, how are you feeling? You say so much better. Thank you. So we're really, we're concerned about bias on the patient's side. What about on the investigator's side? Why would that be a problem? Sometimes there's findings, but research is a form of kind of work. Say a little more about that, because other people may not have thought about that before either. What led you to that? The results of the study. Let me just talk for a moment on the academic side. We'll talk about reputation and promotion, right? And then just an easy, quick question. For a study that shows no efficacy of a new device or a procedure, how likely is that to be published? Again, things may be changing, but I'll just say your first impression is pretty right. First of all, even locally, people are not very enthused about your study. I'm going to make you stand up at a faculty meeting. Congratulations, your new device doesn't work. So that's not going to happen. And the editors are not too... Why do I need to fill my pages with a story about something that somebody tried that doesn't work? I mean, where's the good for that? And then onward to your reputation. If you do publish, everything looks better if you have positive results. So that's actually the bias that we're worried about in double blind studies. Why do we call them double blind? Double mass, sorry. What's the double? So we got the patient. Who's the other party that's blinded? The investigator. So again, that just shows you there's a problem. You're absolutely right. There could be a lot of things going on, right? It's your idea. And when we have ideas, we want them to be right, whether there's financial reward or not. So we'll often see things that reinforce our ideas and reject things. If you ever know somebody who's had a big investment in the stock market and their stock is going down, have you heard them talk about that? Well, it's because it was a good idea at the time. It's a good company, and I'm sure it will get better. That's a really good example of just the psychological process of wanting to be right. Fair enough? So we found a solution to that. It's not perfect, but it's pretty good. Double-blind that blocks both of those. And what we're hoping is that we'll have a more objective, more bias-free result at the end of the day. And you mentioned financial conflicts. I'll just underline. There are many. We just talked about them. But financial ones have drawn some of the most attention. The other thing to remember is they're actually easier to identify, right? I mean, how would you know that I'm biased because I want to be right? What question would you ask me on a form? And what would my answer be, right? If you said straight out, would you falsify the results because you really invested in wanting to be right in this study? Would you answer that yes? I wouldn't. I mean, I think that would be very unlikely. And can someone prove that I really do care so much about being right? It's difficult. But if the question is, have you accepted a payment above a certain level, you know, in the last year, that's actually pretty easy, isn't it? Because if I suspect you might have paid you, if I'm the government, I can answer that question really easily, right? I can leverage the question and go to a manufacturer who requires a license. And I can say, I want you to tell me all the docs that you've paid in the last year. They will probably say yes. If that doesn't work, I can do record searches, right? But as a person wanting to find out, money is really easy. It's easy to track. Fair enough. Other things about disclosure. So now we're talking about financial, not financial. We reviewed the problem in research, which was bias. We talked about the solution. What's the problem that people are going after? Bias is the beginning of it. Yeah. Go ahead. You're a researcher. So take what Nick said and turn that into a problem. First of all, I was using a couple of words that are really important. We'll go back to those. The question is, it's an assertion. Real is important, but so is perceived. So one of our challenges is to talk about what is a conflict of interest? And is that the same as a perceived conflict of interest? And then he went on to talk about, in a way you could read that as different loyalties, working for one company, but having a different role, et cetera. What's the problem at the end of the day that people would really worry about? I'll try this. What's the harm? Because in your stories about research, the harm is actually a bad result, a false result, correct? We're pursuing truth. Truth is the goal and something gets in the way of truth. We call it problem and we try to fix it. So now we're talking about bias. So bias is real and we're trying to fix it, but what's the harm? What's the harm that we would think would happen when investigators, faculty, private practice physicians have money from another source? Someone else was waiting. Yeah. So again, just for the comment, when you're thinking about, first of all, in the research studies that are now double-massed, do you remember much conversation about the magnitude of the error if it was not a mass study? I mean, what we all accepted was it could be wrong. Fair enough. Do you remember any discussions about 5% wrong, 10, 50, 60? No. So a really interesting difference here is that in solving that problem, I'll call it research bias if you like, we developed a solution independent of anything about magnitude. And we actually have that for studies you might not think are too important, right? I don't know what that would be in your field, but say a new device that's not that big a deal and might not affect that many people. We still want the studies of that double-massed. Another study which is about saving lives from another terminal disease, right, that might be studies of thousands of people, we want that study double-massed. So my only point there is that magnitude is not an issue in trying to solve that problem. We just, we never, I can't remember ever hearing somebody saying, you should do a double-mass study because if you don't, your results will be off by 62%. I just never heard that. So your point, the point over here was her experience with financial disclosure is people are asking questions about the amount of money. We already mentioned to Nick that there's a thing about the length of time, right? Who knows that three years is the amount of time that financial bias is important? Why isn't it four or why isn't one or six months? But they pick three. So that's a magnitude number and your point was the amount. Somebody recall the amounts that you required to report since she brought that up. What is it that the institution is going to ask you about? Or maybe a journal. Yeah. So thank you. That's really eloquent. So the comment, if you can think of it as a very directed comment, I ask what's the harm? We're going to get back to your question because it's also very important. What's the amount, right? And there's a connection. It sounds like somebody is thinking that there's a particular amount that might be associated with the harm. And so they're planning their solution that way. Let's just talk a little bit about what was just said. So first of all, the harm, we're medical people, right? So the harm that you identify, if we were economists or accountants, right? Or maybe even the CFO of a corporation and you said it could cause financial harm. That would really get our attention. But you very carefully sort of said, well, harm, maybe not to the patient, but to somebody. So it's an abstraction that I'll just put it back in my hands. So I'm a drug prescriber. So every day I have choices that I can make about drug A or drug B for the particular infection that I'm seeing, correct? And some of the drugs are more expensive than the others. And your colleague just said it's not always the case that the more expensive is the better drug, right? It doesn't follow. I never said it never happens. It absolutely could. But we're also obliged to be evidence seekers, correct? So it's within my power. We'll talk about that. It's possible that I could discover the relationship between the cost and efficacy, right? And if I prescribe the drug that costs more and does less or no more than a less expensive drug, it could be said that I'm doing financial harm. Who are the people who would feel harmed by that? I'll make it really easy for you. If my patient is 72 years old, who feels harmed by that? Yes. So let me just stop you. So if you're looking for where these solutions came from to this problem, you want to think about what you're hearing. So the problem is conflict of interest, but it's more serious than that. It's what can happen with conflict of interest, right? It's not about conflict of interest per se, but it's about the possibility. The possibility, and your colleague used it, she said if the drug company wants to sway, was that your word? Sway the opinion or persuade the physician. They have many ways of doing that, right? One of which would be giving gifts or money, right? Because we know that that works, that helps. And at the end of the day, what they've persuaded you to do, you want to look at not only harms but benefits. So if the harm, and you're right, it may not be directly to the patient, but let's make it to Medicare. Who is harmed by that? Everybody. I mean, pretty much everybody. And at the end of the day, if there's enough of that, it actually rolls back to the patient, right? And I'll just tell you where it rolls first. It rolls first to the uninsured. Because billers need to recover what they're not collecting. And if in fact, you know, drugs are more expensive or the choices are more expensive, somebody really does have to pay for that. So the uninsured patient pays cash. The Medicare patient pays a deductible. But next year, even the Medicare premium, for those of you that know about this, Medicare is not free to everybody. There are co-pays and there are costs that people of higher incomes pay when the cost of Medicare goes up. So it's not free, but it's a little unequally distributed. But isn't it clear in the case of Medicare, it's that entity which I'll call for the moment, the government that's impacted. And by the way, they cover a lot of lives, right? Well, add the VA. They're heavily covered or affected by that, too. So now we see the harm. Where is the benefit? Let's go back to if the company sways or persuades people to use the more expensive, but maybe equally or less effective drug. Who benefits? Sorry? The stockholders. The stockholders, which is a very big group. I mean, you want to think about the people who own any one company, Lily, Merck, Pfizer, or people who own ETFs that only own drug companies and lots of them. There are people who are very advantaged by my practice. I'll go back to me, right, of writing a prescription for a drug that works. Let's remember I'm not hurting the patient. It just may not work as well. Or maybe it's just equal. But it costs, it could be five times, 10 times, 100 times as much. So now we've thought a little bit about the problem. So the harm is largely financial harm. That's what we've talked about so far. Is there any other harm that would be linked back to this idea of financial involvement? And by the way, it's pretty straightforward. This is now financial conflict of interest, one kind among many. And it's a particular kind. It's about the pharmaceutical industry as a payer and physicians as a recipient. So we're just, we're kind of bringing it down. And we've heard one harm which is financial. Yeah. You were thinking about something. So you realize we're not advancing slides, right? But it's because you're teaching me and each other the critical points. You're actually deeper in this already than a lot of people. A lot of people are just annoyed by all the forms they need to fill out. They haven't had this conversation about what's the problem and what's the solution, right? But now we have two themes, right? One is financial harm largely experienced either by private big insurance companies, by hospitals, right? And by third parties like Medicare or the VA. That's pretty big. That's a very big deal. So that's important. But now we have another theme. And I think I heard correctly, harm to the reputation of medicine, a lack of trust. I really want to underline that because I think if you think about conflict of interest and bias, the problem in all of them is the inability to trust an outcome or a result. In research it means I'm dubious about the meaning and the validity of your study. In prescribing, right, I'm dubious now about the appropriateness of your choice. Here's the deepest part of that. If I'm a patient, I believe and I've been told that you've put my interest at the top of your list. When you take oaths, when you talk to people about what you do, you're a physician, everybody understands that being a professional physician, being a professional, means that you're putting the interest, some people would say client, doctors would say patient, above your own. That's the standard. It's a very peculiar standard. We're expected to put the interest of someone else above our own. It's one of the reasons that I see surgeons flying back from their vacation to operate on people that have had an unexpectedly bad outcome or a complication. I can't tell you how many times I've seen that. I mean, that's because what was more, they're on vacation with their family. I mean, that's an interest. But they're flying home. When they do that, I can only tell you they're appreciated. But in some ways, that sets the bar. That's not a random event. That's actually not all that unusual in your field. Given that, that's the expectation that we're threatening with this idea that you said is very prevalent on the internet and in media. And the impression is... Say again? In the exam room. In the exam room. Say more. Well, it's medication, but I think that they did that because the complexity with which the patient is reviewing the situation is much greater than I think we give credit. I think that there's a level of suspicion for bias that permeates right now. So that's a really critical point. And I think it's actually the driver. If you look at who made these regulations, they're now coming from very different places. I think I mentioned in the beginning, you might expect to see them from people that were harmed financially. And you did. That is, insurers really don't want you doing things that will cost them more money than they need to pay. The government very early was sensitive to something your colleague just said. Some physicians own facilities that do diagnostic procedures, right? A perfectly good example. A neurologist might own an MRI facility. A doctor might have an X-ray machine in their office. So one of the things that happened years ago and got a lot of attention was called the STARK regulations. Not because they were STARK. It was the name of the legislator who drafted the bill. The idea was, and that's pretty clear, isn't it, that if I own an X-ray machine and I can charge you, you pick a number, make me my cognitive underpaid specialist, right? I can have an X-ray done and charge you 100 bucks, or I could spend 30 minutes with you and charge you $40. Why would I not spend 30 minutes and recommend an X-ray? Right? It's pretty straightforward, and that's a perfectly good... Some X-rays were appropriate. So let's not say they were all unnecessary, but that's an acknowledgement that with that kind of interest, and I gave a monetary example. I haven't forgotten your example. So for me, it's an extra $100 for writing with a pen, right? And so the STARK amendment said, you must disclose to the patient that the X-ray machine or the MRI is your machine. So that was a good example of thinking about a problem and proposing a solution, and the solution was disclosure. So we've talked about that. This other notion that you talked about, doctors are the shills, use a lot of great words. Did you say patsy? Shills, patsies. Another one is puppets, right? Spokesmen, spokespeople. An area that we didn't talk about was continuing medical education. We've actually talked about publication, presentation, faculty hiring, right? Research, but not yet about education. So one of the things that they've read about is that people who are speakers at national meetings, how about this? People who are writing guidelines. Are you with me? I mean, I'm gonna feel very simple to write guidelines. First, if you have malaria, what's the drug of choice? Even more interesting would be pneumonia, a really common problem for which there are dozens of different drugs. So the public is upset if it finds out the chair of the committee that wrote the guideline for pneumonia that recommended drug X is actually on the payroll of the company that makes drug X. You with me? Now, that's not proof positive that that person made an incorrect recommendation. But Nick mentioned perception. You think about that. How would you feel if something that was recommended for you, an automobile, somebody doing the safety standards for the automobile, was working for the manufacturer? I mean, it would be disturbing, yeah. So this is really a very important issue for your faculty and for residents to think about. If I came to you as a resident and I said, you know, I think you could be a thought leader in retinal surgery. You know, you're a fellow in retina and I think you could be a thought leader. I'd like to bring you to a conference to meet some other thought leaders. It's in Bermuda. It's going to be great. That sounds good, doesn't it? I mean, first of all, it's flattery. You appreciate that. This is a great word. And the new term is K-O-L. So it's key opinion leaders. And thought leaders is sort of intellectual. But what the manufacturer really wants is somebody who's a leader. The key is leader. It could be because of their position, reputation, connections, institution they work for. It doesn't always mean they're the most thoughtful person, but it does mean they're key. That is, if you hear their name, and that was a lovely example, if I come, someone comes to me, Jay, you know, I think that this is what you should be doing for cellulitis, right? I see that every week. Why should I do that? Well, Dr. Jay at the Brigham has done a study that says this is the best drug. That's actually my world. That's how I think about things. I trust people of reputation. I trust studies. You tell me that that might be a shortcut for me. I might not need to read the study or the seven other studies, but I'm very influenced. That's why they're not just called thought leaders. They're key opinion leaders. They're changing the way I think. It's very important. And again, it could be very positive. Those are very highly rewarded people. And we'll talk about that in a minute. But they're making a difference. By the way, they're often speakers at national meetings. We should have remembered that. So the public has been reading about this, and I would just support what you've said. The reputation of physicians in the level of trust has actually been declining. Currently, the public trusts pharmacists more than it trusts physicians. And it's fascinating to think about they're in the drug industry, but they're not so important as opinion leaders. I'll just tell you, I'm probably more likely to be influenced by you telling me that the chairman of IB at Harvard likes this drug than some pharmacist. So we got it. Other quick thoughts about that. We've heard about some problems. The problems were financial harm and harm to reputation and loss of trust. And now actually, you're hearing a proposal for a solution, right? Better communication. We'd have to think a lot about what that would take because the forces in the other direction are actually very powerful. If you look at physicians in the drug industry on the internet, you will be amazed at what you find and even some of the titles of some of the books about that. There's a lot of damage there. So one of the things to ask yourself is what can I do about that and what my profession do? I will tell you, again, we'll make it short. You're such a good group because you don't see me flashing slides. It's because you're developing the information. One of the things that doesn't work, do you remember this phrase? It'll be the faculty, not the residents. Who said, I'm not a crook? They're laughing. Do any of you know? Ask them, who am I talking about? Richard Nixon. And what happened to him? And at the end of the day, he resigned but under threat of impeachment. So I mean, that's about as bad as it gets for a leader who was distrusted, whose reputation was damaged, but who then tried communicating and said, it's not true. I'm not a crook. I want to let you remember that as an example of how ineffective it is to say things like, I'm not one of those. That is, if they're reading, and I will tell you, they're reading things like 84% of physicians take money from the drug industry. And you say, I'm not one of those. That could be true, but the odds are only 16% that it's true. They read the papers. And so if you're saying, I'm not a crook, I'm now talking from the psychology literature, not medical. I'm not a crook. Remember this other phrase, the lady does protest too much? If you say, I'm not a crook, the way the public reads that is you wouldn't be telling me that if it weren't true. So part of communication, you might think of saying, well, no, no, I'm not like that. I would never let a nurse do that. I would never even do that. You're part of the profession that they're distrusting. They're distrusting solutions. Yeah. So you've just addressed another huge question, right? Which is, how far can we take our relationship with patients one at a time to address the problem, which is actually much bigger and what you've acknowledged is even trying to get it straight with the patient understanding their problem, maybe not about conflict of interest, right? It's now about communication, about, and one of the first ones is listening. You remember that we've learned that we interrupt people about every 14 to 18 seconds? So that's actually a hard way because we have an agenda. We're interrupting because we're trying to keep them on track, right? When do you see double, right? If you cover the other eye, what do you see? And they're trying to tell you something about a weird sensation from that. I don't mean that personally. I do the same thing, right? I ask people weird questions, like, do you have turtles? And I'd rather know that with somebody with diarrhea, right? Then, well, my uncle, you know, came to visit last. They think something is important and they're trying to tell me that and I'm editing that as we go. So one of the fascinating things is if you let people finish their sentence, right? You actually learn a lot. You learn a lot of things, but you learn the other one is, and back to your point about trust, they actually believe you're listening. And that actually means the likelihood that when you ask them a question that might be a hard question, that they'll answer it truthfully because they trust you. So a lot of dynamics. Okay, I'm going to run some slides here mostly now to reinforce some of the points that you've made. Let's see. And we may not have time today to compare one kind of disclosure with another. So the question of which is harder may need to wait for another time. I think we will talk about effectiveness. Remember, we set this up. We understand the problem, bias, conflict of interest, the harm, financial and reputation. So the question of effectiveness is does this solution that we're going to talk about, disclosure is the solution? Or does it harm and does it improve reputation? Those are the questions you should be asking while we're doing this. So what are my objectives? Well, first do some more defining. I think we've already heard a couple of things about that, but I'll show you a couple of slides that I hope will make it really, really clear to you that conflict of interest is a state. It's a status. It's something like saying you're 72 I mean, those of you that do retina or cataracts, are you ready interested? Or macula? The fact that you're 72 and have two eyes is true. It also means you're at risk. Each of your eyes is at risk of something happening. Age is a risk factor, but so is genetics, so is occupation. There's a lot of stuff going on. So what I tell you, you're 72 and have two eyes, you're not thinking I'm attacking, if you're a patient I'm insulting you. But when I say you have a conflict of interest can you be honest, how many of you think that, does that make you uncomfortable? How about if I say publicly, is Randy here? If I say Randy, you have a conflict of interest, you can speculate. How does that make him feel, how would you feel if you were in the chair? It's like an accusation, isn't it? It's very much read that way and I think that's partly a problem of language. If I just said you have a lot of interest, if I said that to you at a cocktail party it would be like you're ready to talk to me, right? Hunting, fishing, fixing eyes, traveling. I mean that's just great, having interest is good. Conflict of interest not so good. So just so you know it's not an accusation, it's a state. It's a fact, it's just there. It can be there or it can be perceived to be there. What you're really worried about is the perception that your conflict of interest is not just a state, it's a state that you'll respond to by making bad decisions. Is that clear enough? What people worry about is not necessarily that you're a bad guy but now they're worried that you might be. So the word may is going to be very important here. So in part of the definition we're going to talk about an interest in one hand and an interest in the other that may cause you to make a decision that doesn't equally balance those. And for physicians the interest in one hand is what's best for your patient. That's actually one of our interests. We've said that. The other interest is what's best for me. And by the way finance is not the only place where that happens but that's where the public's attention is and when you acknowledge a conflict of interest I have a lot of finance from here for me and I have your interest over here what you're worried about is the perception that the public thinks you will be vulnerable to making a decision that will be adverse to them and good to you. And I will just tell you they're right. I mean you are vulnerable. It doesn't mean per se that every physician that has any amount of money back to your question will make an adverse decision. It doesn't even mean who earns a lot of money will make a bad decision. Let me give you the extreme example. You want to imagine a physician who works for a drug company. He works for the drug company. I mean that's everything. It's not part of his income. It's all of it right. Do you think that there's not a physician in that job who would make a good decision about a drug for the public. I have to tell you it's possible. It happens every day right. People in their company I don't think we should market this drug. It doesn't look right to me that the therapeutic profile the therapeutic index is not what we're looking for. I know there's a big market we could have a market share but a responsible physician would say we shouldn't do that. And there are people who do that every day. There are also people who look at the potential revenue from that drug and who say well you know it's not that great but it's not that bad why would we not want 5% of a $2 billion market right. And next year I could be the head of medical research instead of the assistant. The point being just having the conflict of interest doesn't define what you're going to do but it puts you at risk. And the public believes that. And they're not wrong that is if their belief is it could persuade you or sway you they're just right. By the way just if we don't get to it the comment about money you've actually heard the answer. Do you believe that answer? Do you see how far down the scale she went? She says it's not about the money even a pen could make a difference. Do you believe her? Right. So some things are more important than money a nice word to remember for that in your practice in your experience is relationship right. My wife she gave me a lot of money I didn't have student debt this a long time ago but I would have had without my hand. So I'm pretty indebted to her for that but on any given day she doesn't give me a lot of stuff certainly not a lot of money but I'm in a relationship right and it means a lot to me and I will do things that favor that relationship sometimes that are in conflict with my own personal interest fair enough so relationships are important and pens may actually be part of a relationship right it's called the gift relationship and if you don't think it's important think about how you feel when somebody invites you to dinner you have dinner at their house you hate them and you hate the meal but what do you feel obliged to do. One if you're you know usual you want to thank them right we usually do that you don't mean it but you'll do it. The other one is on the ride home you're already talking about what are we going to do about inviting them to our house right and who can we put at the table that will make it bearable right. So what you're looking at the neuroscientists now are incredibly informed about what that's about there's actually a center in your brain that lights up when you're given a gift or even praise it lights up that's connected to a cognitive part of your brain that remembers that sensation it feels good and there are hormonal equivalents here I mean runners understand running makes them feel good receiving a gift even a small gift signals that somebody loves you. I don't not suggesting the drug company rep is in that category I'm just telling you that's the way the signal is at a subconscious level it feels good and it's then connected to the cognitive part of your brain which when it's trying to think about what's good for you is interrogating all kinds of things information but also sensation and emotion well we talked about the word bias now we can use a word that may be redundant but we call it unconscious bias so the thing to remember about a gift relationship and by the way lobbyists understand this tremendously is once I do something for you you feel indebted to me at a minimum you will let me come and talk to you that's actually the lobbying solution they don't tell candidates to vote X on this bill they just say we want to help you win your election we know you're a great congressman and da da da but when you get elected and the phone rings and it's from your donor you wouldn't say I'm sorry I'm too busy to see you so it's a great way to think about it it's a foot in the door and it opens the door to persuasion argument information selective information it's very powerful and the point about a gift by the way I'll just tell you because we may not see the slides that have been shown to influence physicians prescribing practices pens stationary right and meals you want to know the cost of the meal 12 to 20 dollars so you know asking questions like have you received 5000 dollars by the way it's now 5 it used to be 10 so people have been thinking about well where is disclosure important and they've been thinking about it in terms of magnitude and money and what I've just told you and what you observe is that the amount of money is actually irrelevant it is about the gift relationship and the two words are important gift and relationship so when I take money think about the dinner invitation I feel obliged to ask you back you did something for me I don't really like you I don't think you're the best cook but I'm going to ask you back to give me a thousand dollars to speak at a meeting or you pay my travel and hotel and a fee to speak at a meeting in UPIC I don't know where ophthalmologists like to go maybe Hawaii or maybe something more exotic right well I feel indebted to you remember some of this is unconscious so the next time I speak when somebody asks me a question about different drugs or devices the process is going on in my brain I've read a lot of literature about this but I'm a little bit more likely to spin that in the most positive way because I feel indebted I sort of owe that it's not conscious it's not like I'm going to stand up here and lie to you because they took me to Hawaii there are very few physicians I think that would be in that category but we're just all human so there's this pleasure center and there's cognition it's really surprising that that works let's rush through a couple of other things here are some objectives look at how many you've already talked about I'm going to actually show you in a minute the definition but you've done a very good job of thinking about what conflict of interest is I just want to emphasize what I said that it's not it's not an accusation about your character it's a comment about the status that you're in but it is like being 72 and having two eyes it says there's something at risk here but we need to know more before we can decide that you're one of these people that has the risk right for you it's vision impairment for conflict of interest it's making a decision that could be harmful oh let me just go back to the objectives so we've already talked I think about most of these context we emphasize the places where you're required to disclose but I think I want to be clear that this is important in many different ways we've talked about research we've talked about teaching we've talked about publication it's actually very important right in the clinic I mean it's actually important in your interactions with patients again for me every time I write a prescription it's a relevant issue and it's a fair question if I'm getting rewarded for certain drugs and I happen to write that drug now it's actually a question of why if I wrote a script for a drug that I'm not rewarded for frankly it's the same question am I sure that it's good but it's not as complicated this adds one complication to every decision we make if it ties to financial gain as far as how we've gotten here I'm going to try to race through that and just tell you ahead this is new it started with scandals it started with very highly regarded medical professionals at big institutions that were found to be cheating it also started when they were found to be lying about their results medicine was one of the most esteemed professions it really was people trusted implicitly their doctor and doctors in general but when academic thought leaders were found to be falsifying data and taking lots of money from industry and making recommendations and policy recommendations about their products the public was enraged I'll just tell you that's a very good story those were headline stories in the New York Times that's actually something a reporter would be very excited to discover so he had a bunch of those in the 70's and 80's and that's actually where these regulations came from it got so important that there were congressional hearings so there were hearings about this and then there were policies and regulations generally through the public health service now through CMS and everything that you've said is a reflection of that the institution wants to know about your conflicts because the government is going to ask them if you're accepting a grant the NIH who's funding that grant wants to know by the way the NIH was part of this scandal did you know any colleagues who lost their jobs at the NIH it became clear that many people at the NIH maybe the most influential place for policy in the United States were being highly paid by industry so the NIH got very busy and has stricter disclosure rules now than you have at the University of Utah but so scandal is kind of what drove this and I'll just tell you scandal meaning a few people that did really egregious things but that's what the public focuses on anyway it's often what legislation focuses on and benefits, risks and difficulty of disclosure the two context were to be financial conflicts and error disclosure we won't have time to talk about error but I'll just tell you that the benefits are just they're kind of hard to find one of them is you can get hired you mentioned that you had to fill out a disclosure form to be on the faculty so if you don't fill it out you can't be hired so there's some very personal benefits to you it's not clear yet who else benefits from the form that you filled out risks of disclosure you might think about that we haven't talked about that but you might worry that if you said publicly how much money you get from a drug company or more specifically that you were forced to reveal that to a patient think about me I'm going to prescribe a drug for you for pneumonia I have to tell all of my patients that I've had two research grants from Merck one from Lily and that I was a principal investigator on the group that studied the drug I'm writing in you might think that by telling them that you would decrease their regard for you what do you think risk benefit what is that do you have an opinion so the first answer is I mean that's such a safe thing because we're diverse people right so the answer was some patients might be impressed that's absolutely right some patients might be impressed what about most patients right well the risk would be if they would stop seeing you it's like Dr. Jacobson I'm shocked shocked you know how could you write that for me you're too close I'm sure you're biased I'm leaving that never happens so I can tell you it's not about most that's just about never so that never happens most people when they're asked about the opinion they say they trust them more I'm going to underline that for you so that's a good one for you to think about in terms of disclosure right this is disclosure financial you told me where you're getting your money from wow the car dealer doesn't tell me that right and I know that they're distrustful or untrusted but you just told me something that could seem to be dangerous to you it sounds like you were putting my interest above yours thank you oh you were a principal investigator on the study you're an expert right you're one of the speakers for the drug company you obviously know what you're talking about so that's a paradox so it's a really good one to remember about risk benefit in this particular case physicians thought it was a risk because we thought it was something about our character I'm going to tell you that I'm a crook right that's what they read I have to disclose this I'm telling you I'm a crook that's not how patients hear it and the person who asks about communication in the back here's another gift don't interrupt people or tell them where you're paid from both of them tend to move in the positive direction odd okay so definition so this is from the Institute of Medicine when professional judgment concerning a primary interest they spell that out our primary interest is two and particularly for the faculty patient welfare and the validity of research and we talked about both of those today so here you go so a conflict is when a primary interest primary meaning most important that should be on the top of our list may and I underlined it for you and this is my evidence that it's not an accusation it's just a situation it's a state which could lead to trouble but doesn't necessarily may be influenced by a secondary interest and again the example is financial gain it could be other secondary interest but this is the definition there's another one that says a conflict of interest is a conflict between an individual's professional role and his or her personal interest so the key thing there is role because role defines primary interest so that's the simplest way to do it my professional role and personal interest how would you know and this goes to next point about perception how would you know when this might be a big enough problem to influence judgment we said that it's just a state it may influence it how would you know when it's up to that level where it goes from may to it is influencing so here's a standard that most people use and I use the word diagnosis how can you know it's kind of like how can you have enough impaired vision to require surgery well it's a professional that decides that right not every patient who says I don't see as well as I used to is a candidate for a retinal repair or a cataract you need more information but you make the diagnosis well here it is financial the F is for financial exists when a reasonable person would interpret the financial circumstances pertaining to a situation as potentially sufficient to influence the judgment of the physician in question so just back to your point about money now it's about a reasonable person there are many reasonable people who don't think a pen or stationary or a meal or 20 or 50 or 100 or a thousand dollars to a very highly paid professional would make a difference so for that person it wouldn't rise to the standard there are other people including social scientists who think that remuneration of any kind is enough so you could be thinking about your audience right what audience is this and at the level of federal regulation that's an audience so you had members of congress and expert witnesses and scientists etc trying to set rules that reflect their view and in 1995 they required you to report gifts of 10,000 sorry money of 10,000 dollars in 2011 they changed it to 5 so that just tells you how they're diagnosing it it's not necessarily the truth or the way patients feel about it frankly it's not the way economists feel about it or behavioral economists but it's what the regulators thought so that's the diagnosis so this just reiterates what I've said and Nick talked about perceived but I wanted to talk about this one some people say oh what I have is a potential conflict of interest that's not right the conflict of interest is a state you either have it or you don't it's not like I have a potential pregnancy I mean it's that clear I mean it's a state to say that you have a pregnancy doesn't mean you're gonna have a badly affected child or a wonderful child you actually don't know but you are pregnant so there's no potential if you are taking money and it's from a source or an interest other than the patient's best interest that's a conflict what's potential is being dishonest or inappropriate right so just that's a really good one to think about and that's a burden for everybody for the regulators just because they know you've taken money doesn't mean that you've been deceptive dishonest but it's actually true for you too and you look at it or you should think about it differently they'll know you are dishonest by measuring things I'll show you a little data in other words if I've taken money and I'm not prescribing the drug of the source of the money any more often than my colleagues who haven't taken money I'm probably within the norm right if I'm prescribing it two times more likely and they ask me why and I can't give them a good reason that's a good example of my behavior being inappropriate I'm really doing the wrong thing as judged by my peers et cetera and there's a record of that by the way the pharmaceutical companies you must know this know the drugs that you prescribe so when they call on you and they talk to you they're doing that with the information that you either never prescribed their drug you're a mid range or you're a high prescriber so they're gonna work with you at whatever level is appropriate right by the way you get gifts any way at all if you're a high prescriber they will comment to you on your sagacity in choosing that drug and reward you for that if you're a low prescriber they're gonna gift you so that they can be confident you will see them over and over so they can continue to tell you about the good studies that support their product so again you wanna think about this differently than the regulators what you wanna think about is the word may are my decisions influenced by my conflict of interest or not if you ask physicians if a gift of $50 will influence their judgment what will they say no overwhelmingly I mean that's in the 90% range would you be influenced by a gift get ready for this if we ask the same question and say would your colleagues be influenced by a gift of $50 what do they say it's almost the same it's high it's about 80% so what you're seeing there is very human right I'm honest I'm good I'm right but you know human beings are not so reliable so either I'm not a human being or I'm exceptional but that's a problem so that's actually why you're not asked questions like are you influenced by your gift they're just asking you is there a gift or compensation I'm gonna skip that and just say what could we do about this problem we've named the problem financial reputational trust by the way it can harm we didn't even talk about that I'm embarrassed this can really hurt people I mean your example about stem cells and eyes I mean we've done some really horrible things that actually link to financial interest right I can give people a drug which is more expensive and maybe less efficacious and it may be in a life-saving situation I'll just pick pneumonia I mean there are big guidelines that are written to tell people what to do if in a particular case I make the wrong choice and I choose something that comes unconsciously to my mind because of this gift relationship and bias and that patient dies my inappropriate decision is big time really big for you maybe thinking about devices other things that you do new therapies which have been highly promoted I mean there can be real consequences to patients so what can we do we could ignore them we could do what we did for most of history is just let docs worry about that at a time when docs were highly trusted the public was not asking for this government was not insisting on it it was happening it wasn't happening at the rate at which it's happening now but it was happening and we just ignored it we could prohibit it and I want you to think about that I'll show you some examples of where that's oh I'll give you one that may be relevant to your medical school it turns out that drug company lunches for residents and maybe the residents want to comment I had lots of drug company lunches when I went to medical school did you have them at your medical school you did do you remember anything about that do you remember what drug companies do you remember the food you got pizza yeah pizza is usually from the faculty it can be from the drug company on a budget I will just tell you that drug companies have been in the habit now of bringing lunches to doctors offices maybe the people in the community can comment on that they bring very good lunches now again that may be a difference between residents and faculty think about thought leaders they're pretty sure the faculty are writing more prescriptions and will influence more people so you get better lunches and that may be a comment about magnitude but it is about getting entrance right it's a gift a good lunch so it turns out that that's changing and the change from the bottom the American Medical Students Association decided to score academic medical centers on their policies about gifts and visits from drug representatives and it turns out I can't tell you about the University of Utah but universities in the west and we're in a group score very well and what they've done is prohibited drug company sponsored lunches at their institution they're gone many of them have prohibited drug representatives from coming on their campus without an appointment some have forbidden them from coming at all some have forbidden drug company sponsored CME programs some have forbidden their faculty from being a drug company sponsored speaker those are all prohibitions so you just you want to see there's some of that around if you want to see prohibitions go to the NIH and the VA these are two government organizations who have very strict prohibitions on what their faculty can do I'm running out of time so let me just hasten you don't need to read that other than the dates and the agencies so congress the public health service the American Association of Medical Colleges all of these have been busy reacting to those scandals and writing regulations about disclosure and I just thought you'd want to see this this is a recent study doctors treated to one meal I misquoted the amount it wasn't 12 to 20 it's 12 to 18 18% more likely by the way this is one meal one meal 18% more likely to prescribe this branded drug 70% more likely to prescribe another branded drug and 52% more likely to prescribe the third all of those are agents that are either equal to or inferior to the generics last point that's one meal more than one meal increase the rates for all of these okay I think I want to stop because of the time and just tell you about our objectives and see if we're there you've seen conflict of interest to find you understand the problem you've heard that the solution has been disclosure we haven't had time to tell you everything about disclosure what I did tell you is if you disclose to your patients they actually trust you more so it actually gives you more room to do things that might be inappropriate okay so that that's not a good thing if you put your conflict of interest with your publication your peers read that they make judgments about you but some of them are thinking cheapers if he can get funding from X maybe I could too so it's actually set a norm and a huge percentage of academic physicians now have to report on those disclosures so when you see them on every article you come to believe that it's actually normal to have them and you're supposed to discount the point of disclosure is you trust the right or less that isn't true that is it's never been shown that when you read an article and it has conclusion and it tells you the conflicts of interest that you say oh that must be wrong they say it's the best drug for this at the best maybe the best effect would be say well it's not the absolute best it's pretty close right they might be a little biased so I'm going to just end with that you understand the problem that disclosure was designed to solve disclosure is probably the least effective way of dealing with the possible consequences of conflict of interest a much better way is what you did today thinking really carefully about it and taking a personal stake in that and asking yourself every time whether the decision you're making could be a biased one and frankly the thing that works is prohibition I will just tell you the studies at the academic medical centers that have done that people have compared them with academic medical centers where they're not and if you look at the prescription rate of branded drugs associated with gifts and visits they're 20 to 30 percent lower in the academic medical center that has prohibited that's never been shown with anything around disclosure like if you say to people at lunch this lunch was brought to you by Pfizer what happens is they remember Pfizer and they have a gift relationship when they see Pfizer as the sponsor of a study that has to do with a new drug in their field they're more likely to believe it so end of the day what's the solution a policy solution would be paying you differently for what you do up to 80 percent of research in medical centers now is drug industry sponsored and we may even see a decline in federally funded research so the way of eliminating at least this conflict of interest would be to reward people for doing the right thing that is for doing not just basic science research but pay you for doing the clinical research that shows whether it works or not right and then managing the other conflicts prohibiting what you can and I'll just tell you for example at a medical journal you're asked to disclose a lot the editors sometimes have conflicts of interest so one of the things they do is if I send in a paper about I don't know a new antiviral drug but it's to a journal where the editor has an interest in a company that makes that drug or maybe a competitor they recuse the editor from reviewing that manuscript and that's kind of prohibition it's not enough that the editor puts a note says you know I rejected this paper and I work for Pfizer I accepted it no they prohibit it so prohibit when possible manage when necessary and that's it disclosure thank you so very much we look at this every single day I'm so glad you know usually Jeff tells me a lot to talk about you know it's a hot issue and the time just got ahead of him and he said you go decide so I just looked at the literature for ophthalmology and there is one paper I didn't reference it's about how often ophthalmologists disclose their interest in the journals and it's staggering it's almost never do they do it completely so they pretty much either ignore it or they shortlist them whether that's important or not I don't know but it did remind me and Nick said it it's every day so thanks are you in a nice talk? you made me think of something that's kind of ironic that it sounds like the government institutions now have the strictest rules that is exactly right and yet we don't hold the government to the same standard as far as lobbyists and where they take money and the politicians it's almost like they're the ones that are able to get away with clearly being influenced I know we take care of patients but they're just running the country it's not ironic there's a lot of irony and this is also a very important time because I'll just say this we have a president who has flouted the rules that are there and they actually are often there for staff and hired employees not for elected officials so your insight is terribly important and actually the argument for some political activism which is guys you're the ones who are writing these rules that affect all these other people right and yet you're not subject to them there are scandals occasionally but the rules for them are amazing the scandal was a congressman who was found to have a lot of cash in his refrigerator if you google that you'll see what I'm talking about so that was just so embarrassing to everybody so he's gone there are no rules that limit the amount of money that contributors can give you corporate contributors and no rules about the lobbyists are generally not giving you money directly they're spending a lot of money that's relationship and they're giving you indirects they're saying well you're gonna write a bill about oil in Alaska let's fly you to Alaska and you know we'll show you the sea but we'll also take really good care of you there and you'll see that we're good people and we're the experts so what they buy is access and all I can say is that you're just so right there's a huge irony and the way to think about it is it is about power and control what you're asking them to do is to control themselves what they've done is control people below them and that's why the NIH scandal was so disturbing right because in some ways they were at the top right but they're not the policymaker even there these are physicians that were fired but they're physician decision makers they were the ones that helped write the rules et cetera et cetera so that's really close to what you're saying right I mean that that's being hypocritical it's awful at the next level I think part of the success is what we did today is helping the public recognize how biased or unconsciously biased their legislators are they're not all crooks right but they they don't know this a lot of them are their business people I mean they're not psychologists they feel like we do when asked would this influence me oh no and yet it does and a lot of people would look at our sort of difficult national situation and roll it all the way back to what you're saying they're saying that there's so much influence here we'll call it conflict of interest they are the legislators your point is they have a primary interest which is supposed to be doing what's best for the people right and they have another interest their biggest interest is in re-election and so the people that are helping them get re-elected that's not the same as doing what's best for people and they're confused I you know I wish you well I think that that's part of my point here it thrills me when you say you know you made me think about something that's the whole goal and doctors can be very influential you've got all this healthcare stuff boiling around almost none of it is about me if you're an ophthalmologist and you look at these new proposals you're saying is this going to be better for anybody's eyesight you could ask the question will it be better for me that doctors ask that when Medicare was introduced they say no no no I don't like it because of lower reimbursement but again that was a mistake what mistake it was a conflict of interest which was mismanaged they forgot to put patient interest first but you should be the person who looks at that writing letters to the editor and say holy cow this thing about you know for young people silly insurance plans they don't really cover anything you must have seen them in your training in the ER I mean or occupational problems where people 26 years old have lost sight I mean it's horrible and if it's a chronic problem and they were afraid to go to the doctor because they didn't have the money it got worse and worse and worse right glaucoma would be a good example right so I mean you should that's a great perspective is to just keep talking from your expertise but realizing that a lot of their influence is just what we talked about today a lot of parallels I think it's a wonderful way that you kind of cashed it out keep thinking about that even at the local level or the state level where you have more access that's terrific thank you thanks for being here is there any coffee left oh that's great everybody had coffee I'll take a treat so you know we even talked about filling out forms so I appreciate that we had a new faculty member here so it really is a pervasive problem it's everywhere every single thing every single time it's just a new question you could be asking is what's the point of this what are we gaining what are we accomplishing and it's like a lot of policy it's really why I like research I think in research you always ask a question does this work and you know what you're asking does this work to restore sight or not and what are the side effects right we don't do that with policy all this disclosure has I didn't even share the double AMC has done a study at how much it costs a medical center to comply with the 2011 rules so they just thinking about you and your job they added on an average of three FTEs just to do this and their average investment is around $300,000 so what they do is they have everybody report everything called SFI significant financial interest which is everything over 5,000 now and then the next question is they have to tell the NIH whether they think that constitutes the first one is significant financial interest that's just about do you get money the next one is is it a financial conflict of interest so of about 70,000 reports of financial interest they file about maybe 900 70,900 are called conflict of interest alright so they're pretty much collecting the data and then not regarding it and then of the 900 what they're supposed to do is manage it and their management plan is usually to ask the investigators to come in periodically and ask the investigators to say has this you know have you done your study too long or are you stopping too soon it's a silly management plan but that's the plan it is well three people and very expensive and no one has shown for example and I didn't share with your colleagues you can let them know and you can Google this you might have fun with this it's called open payments and it's sponsored by a group called ProPublica so because the rule requires physicians to report income this group the CMS went in a different direction they went to the drug companies and said we need you to tell us everything that you give to doctors and they have a $10 rule so if it's less than 10 you don't need to report it anything more than 10 or if it's less than 10 but at the end of the year it's more than 100 so if you have 11 $9 gifts you have to report it so it's actually billions now the total is about $8 billion a year so if you take it down what they call general which is like lunches and gifts and travel the next one is research which is about $4.7 billion so you can Google and the public can Google any doc on that site and see how much they make actually yeah that's right you can see what each doc has made and no one has shown that that's made any difference that is if you look at like the doctors and let's say someone who's taken a million dollars and you would think well maybe people will run away from them no they don't have smaller practices I mean they're usually very important people with very good reputation so disclosing to the public doesn't do anything so I mean that's where we are with disclosure and I agree with you the forms seem endless and they seem worse when you think I sometimes have to fill out endless medical histories but at least I believe that if it's a smart doc that maybe they'll figure out what's wrong with me or what isn't because of what I've said I hate it when I have to repeat them but they serve a purpose the disclosure doesn't seem to it's grim thank you so much