 Dear colleagues, I hope you can all hear me. I am delighted to welcome you to today's lecture as part of the 39th annual lecture series of the McLean Center. And as you know, this year's series is entitled, Ethics in the COVID-19 Pandemic, Medical, Social and Political Issues. We are so honored to invite our speaker today, George Anas. Professor Anas is a William Fairfield Warren distinguished professor at Boston University. Is the director of the Center for Health, Law, Ethics and Human Rights at Boston University School of Public Health and a professor in Boston University School of Medicine and in the School of Law. George Anas is the co-founder of Global Lawyers and Physicians, a transnational professional association of lawyers and physicians who work together to promote human rights and health. Professor Anas has degrees from Harvard College, he's an undergraduate, the Harvard Law School and the Harvard School of Public Health. He and I go back to knowing each other somewhere in the mid 1970s or possibly the early 1970s. Professor Anas is the author or editor of 20 books on health, law and ethics, including, I'll just mention a few genomic messages in 2015, worst case bioethics, death, disaster and public health in 2010, the rights of patients, the third edition of which came out in 2004 and this just goes on and on. Standards of care, the law of American bioethics from the 1990s. Professor Anas wrote regular features of law and bioethics for the Hastings Center Report, you know, the leading ethics journal in the world from 1976 to 1991 and a regular feature on public health and the law in the American Journal of Public Health from 1982 to 1992 and where do you hear this? From 1991 to 2016, Professor Anas wrote a regular feature for four separate editors of the New England Journal of Medicine, the feature was called Health Law, Ethics and Human Rights. I was so proud when I had my seventh or eighth New England Journal paper and Professor Anas has more than a hundred New England Journal papers, it's quite extraordinary. George Anas is a fellow of the American Association for the Advancement of Science, a member of the National Academy of Medicine and a former member of the National Academy's Human Rights Committee. He's held a variety of government regulatory posts, including Vice Chair of the Massachusetts Board of Registration in Medicine, Chair of the Massachusetts Health Facilities Appeals Board and Chair of the Massachusetts Organ Transplant Task Force. It is with the greatest pleasure that I invite a colleague of mine from many, many years before, Professor George Anas, George. Mark, thank you very much. That was much more than I needed or deserved, but I appreciate it a lot. It's great to see you and great to be with you and your colleagues today. I hope I say at least some things that we can disagree with that we can talk about. I'm never happy unless I offend at least one person in my audience. Today I'm gonna talk about something I've been thinking about on and off, not constantly, for at least the last 20 years. And you can help me figure out where this is going and why these issues keep recurring. Call this talk Misunderstanding Standard of Care in National Emergencies, but it's more than that. It's not just Misunderstanding Standard of Care, but it's Misunderstanding the Meaning of Care. I think. Next slide. And I wanna look at the question of how we define things and how our definition directly affects what we see as reasonable, ethical, medical care. You understand in this context of both usual care and research. And then finally, in the context of emergencies. Next slide. So I'll start probably the first thing that got me thinking about this a little bit was the very famous 076 trials in Africa in 1998. This has taken us back a ways. And Mark just reminded me this is the only time anyone is to my knowledge has ever resigned from the editorial board of the New England Journal of Medicine with two people resigned over even publishing an article about that criticize the 076 trials. And you'll recall, no, I don't know if some of you are too young to recall, but this was a placebo controlled trial of antiretrovirals in pregnant women to see if they could reduce or eliminate HIV transmission to their babies. The rationale for a placebo arm for this trial was that, and this is true, that the standard of care in Africa is no care, that these women weren't getting any care so that if I had to use a standard of care as a comparison in my trial, it would be ethically acceptable to use no care because that was the standard of care. Now, that argument is so ridiculous on its face that it's hard to argue with because as you know, the crazier arguments get, the harder they get to respond to. QAnon is a classic example of that, right? How do you respond to a group of pedophiles abusing children in the basement of a pizzeria in Washington, D.C.? It's just ridiculous on its face, but many, many people believe it. And many, many people believe, believe me, I was argued with a lot of them, that no care was standard of care in Africa. And the reason Paul Farmer is there is because his terrific new book, Donnie Bola, he does mention his, he doesn't mention its front page, New York Times argument with Metsan San Frontier or what care was in the Ebola epidemic that recently ended and looks like it came back again in Russia, in Africa. But what he writes is this, he says, West Africans, including frightened clinicians, disliked their fates being ordered by those advocating a standard of care that in many cases didn't resemble care at all. And he was exactly right about that. That next slide. That care anywhere in the world for dehydration would have been IVs, it's common, it treatable, it prevented death, yet this weren't used because these, and the argument was because they were Africans and they would put the staff at risk, okay. We'll argue, we'll see later whether you agree with that. But his, my point I wanna make is that it's not uncommon, at least in Africa for people from the West to argue that no care is standard of care. Next slide. The next study that we're gonna look at briefly is a support study. I've called it the most controversial study in the 21st century that may not live up to that hype. But it was again a randomized clinical trial this time using very premature newborns to compare two levels of oxygenation, a high level, so-called high level and a so-called low level to see if it could finally be determined which one was best for children. The research question was absolutely fine. This is a big, this is an important clinical question that had not been answered in more than 50 years that oxygen had been given to very premature newborns sometimes causing blindness, sometimes resulted in death, depending on the dose. Okay, so the way it was questioned, the my only question about this study was informed consent part, right? How did you ever get mothers to consent to experimentation on their extremely premature infants right after birth? It's hard and to give the group credit there were a lot of refusals. So we know that they actually tried to get informed consent. The problem was not trying to get informed consent. The problem was how they described the risks. And this was seen by the researchers and by almost all of the IRBs that reviewed this as no risk research. And the argument was it's no risk because it compares two types of usual care. Not standard of care, same idea, but two types of usual care. And because the infants could have got either one of these levels of oxygen outside of the research trial that therefore this was no risk research. Even though the hypothesis was there was gonna be a difference in the death rate between these two arms, right? Not that the death rates caused by the intervention necessarily. But it could be. So the second argument, this became a big argument was well, they're not losing anything by having the trial randomized. Again, because either side is usual care, all right? And the only thing you could say, I was one of the people who made this argument that they were losing is the ability to ask their doctor and get the doctor what do you think is best for my child? And the argument was that that was a nothing thick because we didn't have the data to answer that question. And therefore the doctor's view was uninformed and meaningless. Okay, and you may agree with that. But we'll talk about that. The argument on the other side was just because doctors don't know everything, doesn't mean they don't know anything. And hopefully their medical school, their experience in residency and their experience as clinicians gives them at least some standing to have an opinion as to what may be the best arm for the child. And secondly, that this information could be valuable to the parents and so they should have it as part of informed consent. Okay, so next slide. And this is also a long-winded argument to highlight Jay Katz's position, which is I think clearly right, that this was all part of the therapeutic illusion. In this case, it was the doctors who had the therapeutic illusion, not the patients because they believe that research is treatment, that the researcher is your physician and that the subject here is actually a patient, none of which were true. This was clearly research. Everybody agreed with that. The physician did not act. The researcher did not act as your physician. He or she always followed the protocol and did not treat the patient as a patient but treated them as a subject in research, the application of which was to be guided exclusively by the protocol. Next slide. Crisis standards of care. I wish I could take a poll. I would like to know if you could figure out a way to figure out how many of you have ever heard of crisis standards of care. And then the other half, then I wanna know, we could do this in the questions and answers. What do you think crisis standards of care are? This is a relatively new concept and I'm gonna argue that it is almost a contentless concept that it's very similar in its own way to the argument that no care can be standard of care and doctors don't know anything if it hasn't been validated in a randomized clinical trial. So crisis standard of care in COVID. I guess one reason I wanna talk about this is because the National Academy of Medicine has made such a big deal about this. Not only since their 2009 report, which was the first time they used the phrase which was done for the Department of Health and Human Services, the Office of Preparedness. But this year, they've had like a half a dozen meetings on crisis standards of care directly related to COVID. Next slide. So in real life, the theory behind crisis standards of care is that in a crisis, the standard of care changes. That by the way is clearly wrong just as a matter of language. But it may be right in a different way and I'm gonna give people a lot of leeway here. The standard of care in medicine and law is except for informed consent is exactly the same and it never changes, right? The standard of care is what would a reasonably prudent physician do in the same or similar circumstances? If there is a resource limitation, the standard of care is what would a reasonably prudent physician do in the face of this resource compromise? It's a medical malpractice standard which obviously bothers some physicians and some physicians thought that we had to change the standard of care in a crisis so I don't get sued like an immunity argument, okay? But that's not true either, all right? Standard of care is set by the medical profession. It's always both in emergencies, in non-emergencies, in crises, in non-crisis, what would a reasonably prudent physician do in the same or similar circumstances? And one of the horrible things about all this is the people on the National Academy of Medicine panel know this, they absolutely understand that but they still don't wanna, they don't wanna acknowledge it in the document and you can tell me why. Now, one of the things they say is no, you can't trust, yes, that's true, that is the standard but you can't trust judges. The judges could change their mind and the case that they point to, can't be very versus spent, is a famous informed consent case and in that case, indeed, the doctors asked the judge to say whatever informed consent is, is whatever the doctors do, whatever doctors do because doctors should always set their own standard of care, all right? And the court said, yeah, that's almost, that's generally true but it can't be true when it comes to the rights of patients. You can't let doctors ignore the rights of patients. You can't let all doctors get together and say, we're not gonna get informed consent anymore. So informed consent goes away, all right? What the court said and what I think is right and what's hardcore medical ethics as well is that patients have a right as human beings with their own body, their own bodily integrity to decide whether or not to accept a medical or research intervention based on whatever they wanna do but based primarily on their own view of what is good for them, okay? And the doctor of informed consent which requires physicians to make certain disclosures before asking for consent is based on the fiduciary nature of the doctor-patient relationship because this is what patients expect and they deserve and that it's not something doctors can disagree with. They can disagree with it but they still have to get consent whether they disagree with it or not. So the more sophisticated view is the standard of care and medical standard of care is always what a reasonably prudent physician would do in the same or similar circumstances except for the informed consent doctor which is based on patients' rights not doctor's actions, okay? But you can see how people might get confused. Next slide. This is the front page of New York Times a couple of days ago. You may remember this. This was about a specific hospital in Martin Luther King Hospital in Los Angeles and how four times the death has four times the death rate from COVID that the quote white hospitals have and the rest of Los Angeles virtually all their patients are Hispanic virtually all of them are poor and the problem is not specific types of resources that aren't available. It's lots of resources that aren't available. Lots of staff's not available and the Latino population simply doesn't get the same quality of care as the white population in Los Angeles. And I think that this is an article by Dr. Fink and I think she nails it. Okay, next slide. So prior to COVID, there had been some work done on crisis standards of care all around the country. All funded directly or indirectly by the Office of Preparedness in the Department of Health and Human Services. And virtually all of that literature which I'm sure many of you are familiar with was about ventilator allocation. What are we gonna do when we run out of ventilators and we have to decide who gets the next ventilator? Let me say immediately, that's an interesting question. It's a very interesting question, all right? And it deserves the research it got. It's not a standard of care question. It has nothing to do with standard of care. It's a triage question. Sometimes you do have to decide where you use scarce resources, all right? Doesn't change the standard of care. Doesn't affect the standard of care. The standard of care remains what would a reasonable, the prudent physician with your qualifications do in the same or similar circumstances, all right? They may, and the point of a lot of these articles was to try to give doctors some guidance. Some of them went so far as to say, oh, you should set up separate committees that committee should make these decisions. And that the last person who should make this decision is the doctor, is the attending physician because it will cause him or her great harm because they're not used to making decisions like this, all right? And they shouldn't have to make them. Well, it depends what you mean by decisions like this. Obviously ventilator use is one of the most litigated medical, legal and ethical questions that there is from Karen Ann Quinlan through Nancy Cruzan through the assisted suicide cases. We've got more law on how you decide to terminate treatment, how you decide to give treatment and the bottom line is whatever the doctor and the patient decide together rules. Now, the reason this became an issue is because it was hinted at and even stated that maybe they're gonna be sometimes when you're not gonna get the patient and the family's permission. Yeah, let me just say for now, we can talk about this and that's never gonna happen in an American hospital. And Governor Cuomo basically said the same thing in the middle of the New York problem. And it didn't, as far as we know, never happened. They're in the first, I guess we're in the third phase now, the third surge of COVID. We can talk about that more. My only point here is even though it was far and away the most discussed under crisis standards of care didn't have anything to do with crisis standards of care or standard of care itself. Next slide. So this is the National Academy of Medicine. This drives me nuts because this is a good organization. I don't say that just because I'm a member of it, I am. But where did they get it to get carried away with this? December 18th, that's really, that's just a couple of months ago. They made an announcement. They joined several organizations called for action to implement crisis standards of care. Again, we have no idea, they have no idea what a crisis standards of care are. It's a made up term, all right? But they want you to implement it. And here's what they argued. This is right from their press release. And just not that usual for the National Academy to do press releases about health policy. So they said the crisis is now governors, health departments, hospitals, and other healthcare sector partners must take immediate action to save lives by implementing crisis standards of care. There's all kinds of things wrong with that statement. Not the least of trying to figure out who's responsible for whatever these things are. Is it really governors? Is it really health departments? Is it really hospitals? And we've seen it all across the country. A number of states has implemented what they call crisis standards of care. I'm sorry, it'll laugh because it's sad because I don't think it gives you any information. And in many states, like my own state, Massachusetts, in New York, hospitals have done it on their own level. Next slide. Okay, so here's the current definition of crisis standards of care. Crisis standards of care occur when a disaster epidemic results in sustained resource shortages that are severe enough to require a change in the usual manner of healthcare delivery that may increase the risk of poor outcomes. Okay, if you can understand what that says, then you can explain it to me or anybody else. Some of you may actually be operating under crisis standards of care, and I feel bad for you, but you can tell me if it's helpful in the questions that I asked. Next slide. So this is a really interesting article, which came out in May at the beginning of the pandemic. And it's from my very distinguished authors. It's argument for crisis standards of care. And it argues that explicit crisis standards grounded in ethical principles will help clinicians define and understand when strict adherence to established resuscitation protocols may no longer be appropriate. So there's a lot of double talk in that, but basically what it says is maybe we have to change our CPR and DNR protocols for the pandemic to meet crisis standards of care. And I mean, people have been around this field as long as I have, have been dealing with CPR and DNR for almost 50 years. It's the one thing that, well, maybe more than one, but it's really one thing, ethicists have never been able to figure out and the clinicians have never been able to figure out, which is why CPR is the only thing in medicine, the only thing in medicine. Maybe you get something else from me. Taking a pulse, maybe. The doctors do routinely without consent that you just do it, right? That's ridiculous, by the way, but we've kind of lived with it. And these authors argue that it's become standard of care to resuscitate, to temporary resuscitation, even when you know it's gonna be futile. And so if we're gonna not do futile resuscitations during the pandemic, we need a whole new set of rules. We need crisis standards of care. Next slide. And here are the words they use for standard CPR, standard practice, typical practice, usual practice, ordinary practice, fair practice, established practice. Trust me, these six adjectives are used in the same article for the same thing, which is an indication that they're not quite sure what they're talking about. For me, it's an indication, CPR is just the wrong model to use. Number one, again, it's the only thing that we do without consent. And number two, a guess shows that ethicists aren't as influential as they think they are. We still haven't figured out how to do DNR, DNAR properly in the hospital. Next slide. Now, you may recognize Sherry Fink again. She was the woman who did the New York Times article. She wrote this terrific book, which if you haven't read, I recommend it, Five Days at Memorial, following the Katrina here, Hurricane Disaster in New Orleans and the Disaster at Memorial. Well, one of the things she pointed out in this book is that the doctors, all the doctors at Memorial, none of them had any idea what DNR meant. In fact, they believe that DNR meant, don't treat anymore, that this person's gonna die. And so these persons were put at the end of the line to evacuate Memorial hospitals, just because they had DNR orders on them. Next slide, and that was wrong. And Sherry argues, of course, that was wrong. And one of the doctors, I forgot to tell you, actually, can you go back to that one? One of the doctors was charged with murder in this case. As soon as the doctor actually injected, I think it was eight, it could have been 12 patients because she didn't think they could be evacuated at the time, to say, okay. The National Academy of Medicine points to that case. And that's the only case they could find, where doctors might have to worry about liability when they're using crisis, in a crisis, when they changed medical practice in a crisis. So we can talk about that. First of all, none of their liability issues deal with crimes. This was a criminal issue, not a civil issue. And secondly, even in her extreme case, the case was dismissed. And I, you know, for reasonable, for reasonable reasons, which again, we can discuss a lot later. But this reignited the notion that we need preparedness and we need plans and we need for horrible disasters like this. And again, that's not a problem. We can use plans, we do need plans. And no matter what we prepare for, it's always seems to be the wrong thing. But it is not an argument for crisis standards of care. And for those of you who read the American Journal of Bioethics, you'll know that Sherry Fink wrote a lead article about six months ago on crisis standard of care for the bioethics literature. And she concluded, I almost wish I had made this conclusion myself, that would probably be better off without them than with them. Okay, next slide. And of course, if you're dealing with rationing, which I think this is all about under different words, so out rationing and triage, where we're dealing with rationing and triage and where we really, really, really needed better rules and better guidance was distributing the vaccine, the coronavirus vaccine. We are, and I have tremendous sympathy for everybody involved in this. But nonetheless, could we do a worse job when we had more than a year to think about this? We knew what the crisis was gonna be. We knew what we were gonna do. We knew it was gonna involve rationing. And yeah, we know, no, we didn't do it, we didn't do it. Next slide, I'm wrapping it up, all right? Here's my conclusion, which I wanna discuss. The crisis standard of care failed to improve emergency response and should be abandoned. The standard of care, as I've said many times, I'll say it again, is always the same. And using this term instead of standard is at best confusing. The institutional level that each hospital should have their own standards of care is simply wrong, all right, as is the state level. If we're gonna have standard of care, a different standard of care, it should be at least national. I'd argue it should be international. The way medicine is, that makes no sense that a patient's resuscitation category is decided by which hospital they came to, or which state they live in, all right? These should be uniform. Informed consent cannot be waived by a group of physicians doing triage. They may be very distinguished physicians, they may do a nice job at triage. The law requires that you get the patient's consent to intubate them and to extubate them if it's not medically indicated that they stay on. We didn't talk about these two things, but I'm happy to. Every time we get crisis standard of care, it's followed by the sentence, we have to do it now, shift from doing what's best for the patient to doing what's best for the greatest number. You gotta do the greatest good for the greatest number, which only begs the question, how do you do that? First, is it true? Who said that? Certainly no legislature, no governor, or no president said that. Did doctors just get to make it up? Did we get this change in practice of medicine when there's a crisis, all right? And finally, legal immunity is unnecessary and dangerous. And I'm happy to say it, firstly, every physician I've talked to agrees with this. But nonetheless, that's the reason this whole notion of crisis standard of care started. That physicians were worried about legal immunity, some physicians were worried about legal immunity with no data, by the way, if you want data, there's no data on this. And therefore thought that to get rid of that problem, we just change the standard of care because you can always sue a doctor who doesn't follow the standard of care successfully and we'll get rid of it. All right, so I talked longer than I thought I was going to, I'm sorry. But we still have plenty of time for questions and answers. Oh, please don't apologize. The, that was a wonderful talk. I'm going to take the privilege of asking the first question, which is I'm fascinated and agree with you that we all don't have to become utilitarians just because we're in a pandemic, meaning that we don't have to only focus on the greatest good for the greatest number. And that- I wouldn't even know how to do that, as I said. And nor would any of us as healthcare providers because it really takes away the whole issue of equity. And what's been fascinating though is the more recent shift in many of the writers and speakers about thinking about the whole issue of rationing, as you call it, or triaging, and that there has been now a great push towards issues of looking at health equity and how to achieve that. So for example, just to give you an example, here at our hospital, as we came to 1B, which was to allow for people over 65 after the healthcare providers got their vaccines, the decision was, since we didn't have enough for everybody over 65 in the city of Chicago, to actually focus on some of the areas hardest hit by COVID, meaning some of those from the lower socio-economic or the poverty index. What are your thoughts about that? Well, my thoughts about that are, we're not, as a group, we're not taking the rationing levels all that seriously. We made the first mistake, I think, again, this is me, saying that we're gonna let each state set its own rules. Now that makes no sense. This is a national problem, the vaccines are produced nationally, they're purchased nationally. Now all of a sudden we're gonna distribute them to the states and say, you make up the ethical issue? Really, it doesn't work. So it's not surprising, we've got people going from state to state, we've got all kinds of rumors going on, different things happening. Now, does it make sense to give out vaccines to people who need the most? Yeah, of course it does. First, but we have to decide, we really never did decide whether we mean the people most at risk of dying if they can track the disease or people most at risk of contracting the disease because of their occupation. I mean, in a prominent hospital that I won't name, although I don't know why not, a Boston Medical Center, makes the argument that their physicians aren't at risk at all because they take proper precautions. So they're safer than anybody else. So then they shouldn't get the vaccine first, they should get it last. If we're doing it for people who are most at risk of death, because that group is not, all right? But that's not your question. Your question was, can we take equity into account here and should we take equity into account? And that was the slide I showed you, Sherry Fink's article about Martin Luther King Hospital, which is a disaster. And the people dying at a much higher rate than anywhere else, basically because they're Latino and they live in a poor area. And should they have, should get some priority in vaccination? I think the answer is yes. On the other hand, you can make an argument for lots of people. I would make the equity argument, but if you wanted to stick with the question of just the survivability argument, they win there too. They're probably more at risk than anybody else of dying of the disease if they get COVID, if they get it. So I think you can justify giving it to them for a number of reasons, but certainly equity is a good one. The frustrating thing about, to bring it back to crisis standard of care. When these guys are writing about crisis standard of care now, they say, oh, well, we have to add that you can't discriminate against people with handicaps. You can't discriminate against the poor. You can't discriminate about on the basis of race. That's brand new. When they wrote about crisis standards of care 10 years ago or even a year ago, equity wasn't an issue. Equity has become like a popular hot issue just in the last year or two, I think. So now we have to do equity too. Well, I would say that that's improved. I wanna read a comment from Gretchen Schwarzian and then we'll have Mark ask his question, but Gretchen wrote this and she's gonna be quoting from Alta Charo. I completely agree with nearly everything you said. Alta Charo is the only person who's given me some insight on why the legal protections might be necessary. So she's looking at the whole issue of the legal immunity. She says it's not just winning the lawsuit. It's the bringing of the lawsuit, but this is costly for so many. So if there is a way to head that off, for example, by saying it was crisis standard of care, and so it's okay to keep people in the hallway because we didn't have a room for them, not letting people sue for their loved one being in the hallway. Alta's example saves a ton of time and money and angst and all that other stuff. How would you like to respond? Yeah, I, you know, that's kind of a made up thing. I don't know, I mean, unless there are lawsuits for that, I don't know. But yeah, normally it's hard, I don't hire for physicians to believe this, but people don't sue doctors. And when they sue, they lose. There's no set, it's literally true what I told you. Dr. Poe, the New Orleans physician who lethally injected a series of patients during Katrina is literally the only physician who's been sued for emergency response. And the only one, you know, do we want, do I want to see doctors get sued for, you know, behaving what I even sometimes even I would call heroically? Of course not. I don't think they will. You know, doctors worried, you know, during my whole career and it's a pretty long career, 50 years about getting sued for stopping by the side of the road to rendering assistance. And they insisted that every state and every state did basically pass a good Samaritan law which held them, you know, not responsible, not legally responsible, fracking in good faith, which is something less than, you know, extreme negligence. There never was a case. There never was a case. It was a made up problem. There never was a case of a doc, except on Dr. Kildare. Some of you are old enough to remember that TV show. There never was a case of the reality of a doctor being sued for acting as a good Samaritan. That means not billing someone and helping somebody because Americans want doctors to help. It's just, it's a made up thing. All right. If you, you know, I know Governor Cuomo said, you should, you're not going to get sued in New York, et cetera, et cetera. Maybe, maybe not. All right. Anyway, yeah, I just don't buy it. Not buy it's a problem. I think it's a made up. Most of these things are made up problems. It's remarkable how well the healthcare system, which is dysfunctional as can be, how well it's functioned for the last year. I mean, you do, you actually do it. I just, I watch it to comment on it, but yeah, I think I really think the last thing you have to worry about is malpractice litigation. And I know you don't want to be sued. I know you believe you're going to win. You will win. And I don't blame you for not wanting to be sued, but I often think of my colleague, Don Danner, he's deceased now, but he used to, he was a defense lawyer. And he said, he always says to his physician, to his physician clients, he's defending, think of me as your physician. I'll take care of you. Don't, don't worry about it. And I think that's sometimes not the physician you want, but nonetheless, that's certainly how physicians deal with their patients. And I think that's how good malpractice lawyers deal with their medical clients too. And then properly so. Mark, your turn. With your permission, I'm going to go back to 2013. Okay, that's not too far back. But when you were working at the New England Journal of Medicine, and you talked about the support study in West Africa, and how it helped bring Paul Farmer from Haiti to Rwanda, where my son was very close to him, working, my son's a non-physician, but great admirer of Paul Farmer. But I want to say that the support study went on in the US and England and Australia, New Zealand, Canada, all over the world. A little trove, yep. In the US, in the US, I want to bring your attention to the fact that I'm sure you know it, that the OHRP, the Office for Human Research Protection determined that the consent process for the study violated federal regulations by failing to inform parents of quote, reasonably foreseeable risks of death and blindness of their premature, usually 26 to 29 week old infants in those days, 26 to 29. The New York Times strongly agreed with the OHRP calling these failures startling and deplorable. However, the New England Journal of Medicine strongly disagreed and they found that the consent forms were adequate and that the OHRP was quote, casting a Paul over the conduct of clinical research. I want to know where you came down on this. Journal at that time. I mean, I thought it was just horrible, but I made a decision which I think was wrong now in retrospect, not to write about this because Jeff got so involved, the editor got so involved in it, I think wrongly involved. It's not the reason I stopped writing for the New England Journal, but it came about at about the same place. I was horrified at the position the journal took there. And Ruth Macklin, as you may know, put together a group of ethicists taking the position, the OHRP's position, and rightfully so I think. But, and the New England Journal published their letter, but not in the printed version, they only published an electronic version. So if you weren't paying attention, you still didn't know that there was any dispute about what happened, but I think it's fair to say that Jeff Draes and the editor was not happy with me because I publicly spoke out about the study and even though I didn't write about it in the Journal because I thought, I don't know why, I thought it would be inappropriate, I mean, I'm not that important a person there, but yeah, that was bad, that was bad stuff. But yes, but unusual, unusual for the Journal. The Journal usually is a lot better than that. Right, thank you so much. Thank you. Oh, thank you for that. So, well, let me push you a little bit on the support study and distinguishing between the risks of being a pre-made 24 to 25 weeks who, if isn't in the study, is also at the risk of blindness and death. And so, at what point do we start saying that some of the risks that we're talking about in the research setting are actually the risks of clinical care as well and how do we not blur the lines? Well, the lines aren't blurred. I wouldn't just say, I mean, I used, a long time ago, I used to this research and this treatment and Judy Swayze convinced me, yeah, there is, and then at some point they converge. You know, at some point you're in the gray area. I didn't know, and absolutely, she's definitely right. The real question for me is how do you convey that to the patients, patient research subjects? To these mostly young women, very young women having their first child and horrified that it's premature and very fragile, you know? And I think that's very difficult to do, but it doesn't mean it's not a research subject, it's clearly a research subject, research study and clearly it's got risks, but you're right. Being a newborn, it's got risks of its own. So you're asking really, I mean, put words in your mouth, but really what you're, the point you're making and whether you want to make it or not is that it's a virtually impossible, and I made this point too, for anybody to win a lawsuit based on the death, blindness or other disability of those children because you can't prove causation. It just can't be proved. You have to prove causation to win a lawsuit. And indeed these suits were dismissed, the few that were brought to court were dismissed on the causation issue because you couldn't find a physician who was willing to testify under oath. Is that being in this study is what caused this child's blindness or this child's death? Because that's not true. It was being extremely premature that caused it. Well, so that gets back then to... And that's kind of... How do we give in a sense then two consents to these families? One is you have a newborn. We're gonna take care of your newborn and your newborn has a chance of dying or being blind. We wanna put them in a research study. We're gonna change the level of oxygen randomly and your child still has a risk of dying or being blind. I mean, I guess one of the reasons I wrote the letter on the other side of Ruth Macklin were signed on to the other letter. Oh, did you? Yeah. Sorry, did you remember that? No, that's okay. And I've been torn. So there are days that I'm willing to switch sides, but I just wanna push on how do we... How much of our clinical risks do we really have to incorporate into a research risk consent? I mean, it gets to your point that there's no such thing as crisis standard of care. There's standard of care. And what we do in a crisis is we have to deal with the limitations. In a sense, what we do in the research has to do with the limitations of what we can do clinically as well. Yeah, no, no, I don't think the research study and how you set it up is problematic. It's not that problematic. The problematic thing was just not explaining to patients the risks. Now, what you say is true. It'd have to be out of their mind not to know the risks. They're not paying attention. No, no, I actually don't think they have to be out of their mind. They just think what they have to realize though is that those same risks hold whether they're in the research or not. No, no, I understand. I get that, I get that. But they obviously know that their newborn is in trouble. Or ought to know that, yes. Unless they're very, very medicated, but they know exactly. No, it's a very stressful time. And really stressful time. I wrote a longer piece about this in the legal literature with my daughter who also gave birth to a preemie. Thankfully not in as bad a shape as these research subjects. But I think, I thought she had some insights as to how you make a decision as a patient, as a mother of a newborn to volunteer for research. Volunteers even the right word there, right? Yeah, yeah. Very complicated. So- Very complicated, I agree with that. Ultimately, I come down to the side that the informed consent was poorly done. And it was the people I blame most for this by the way are the IRBs. I mean, what, what I mean is why do we even have IRBs? Can they take a study like this seriously? While I'm waiting to see if other comments come in, I just want to share that the rest of the individuals are not able to talk out loud. So they have to write their questions. But you have a fan here, Peter Anglos, who's one of the associate directors of the McLean Center who just wants to say thank you that he's been enjoying hearing from you since he was a first year medical student. Well, isn't that sweet, thank you. And that's it. We really don't have a lot of questions, Mark. Did he just win us all over or was he- That's hard to believe because I said a lot of controversial things. Okay, well, so since we have some more time and no one else is taking questions, I'm just going to monopolize because I have questions. So I want to go back to the 076 study. I agree with you that they were not offered standard of care. They might have been offered the standard of practice in the country where they were, but that's not adequate. But I want to push you if the standard of care is something that will never be offered, does it make sense? I think you're frozen. So the other question is, what if the standard of care is never going to be offered? I mean, what patients were getting in the United States, for example, which was a three to four doses of medicine before and during childbirth and that was just too expensive. Well, two things to say about that. One, my colleague Leonard Glanson, I wrote a piece together on what we call economic experiments. And our argument here was, if you believe it's just too expensive to do that, this is not a study about medical interventions. You know what medical interventions work. It's, you just can't afford it. So the study is really a study of economics. It's how much can we afford? What can we give? And I was willing, probably too willing to say, no, you don't have to do 076 as the comparison, but you have to do something active as a comparison, all right? Doesn't have to be the most expensive thing in the world. I agree with that. But it can't be nothing. You can't go to these women and say, we're gonna put you to research trial and you're gonna be randomized. And you may get one treatment or another treatment. No, you're not gonna get, you may get one treatment or nothing. And that's not what they were told by the way. Even if they, I mean, I don't think that trial should have been done if that was the real thing. But at least the women who were, New York Times went over and interviewed a bunch of women and wrote about it on the front page. And at least the ones they wrote about said, they assumed they were getting medical treatment. The person coming to them, getting consent, had a white coat on and that's all. They weren't used to getting medical treatment at all. So that was their assumption. So whatever else again, my primary concern in most of these studies is with the informed consent protocol that people know what they're getting into and I'd be just taking advantage of it. Just being used literally as guinea pigs. And I think we should have stopped doing that a long time ago. Well, you have your muted. Bob Shung, who's a, I started with, I agree. Bob Shung, who is a psychiatrist here in Chicago, previously at the university here, writes, why are doctors so anxious paranoid about being sued? Is medical education slash training so unforgiving? What are your hypotheses? I don't know. It's a great question. Someone at the school is collecting a reject and trying to teach the younger faculty that everybody gets rejected and shouldn't let it kill you. And I decided to write something for that. I didn't know this. The first article I ever wrote for the New England Journal of Medicine was rejected by a eagle finger, Franz Eagle finger, very famous fellow. And he did just reject my article. He wrote a two page single space response to it. Say that. So even though he said that the reviewers liked your article, but I didn't and I'm not going to publish it. And let me tell you what. And he went, boom, boom, boom, boom, boom, beam, beam. And it was an article about medical malpractice, which is why I bring this up. And I realized from that day on that physicians look at medical malpractice a lot differently than lawyers do. Lawyers look at it as just part of life, you know, it's not a big deal and you're going to get through it and we'll defend you and all this stuff. And, but I changed two things I did because of that because of the eagle fingers letter. Number one, I never wrote about medical malpractice in the New England Journal. You know, I've written lots of articles and they've never wrote it just said, not worth it. Let somebody else write it with that. And number two, and I taught medical school for about 40 years. And in my, what was usually a eight to 10 session health loss course, I began, always began with malpractice. And I told him not because I thought it was the most important thing, but because they would think it was the most important thing and I wanted to get it out of their mind, right? And one of the things we talked about was good Samaritan. I said, you know, you may be walking home today and see someone passed out, you know, on the street and you may wonder, you will wonder, gee, am I going to get sued if I stop and help this person? And I try to teach him, they should always want to stop and help, all right? That's part of what being a doctor is, all right? And if they're worried about being sued, not only is there the good Samaritan, but forget the good Samaritan. Their standard of care is what would a reasonably prudent first year medical student do in the same or similar circumstances? And I tell them that is the lowest standard of care there is and they all meet it already. And mostly they seem to understand that, but it's also true. If you ever heard of a medical student being sued for trying to help somebody, even if they hurt them, which they probably would like, I don't want to say they're going to do that. No, it's just, you know, I mean, I don't get sued, but I get the thing, it's bad to be sued, it's a miserable goddamn experience and it's hard for doctors not to take it personal. I also spent like six years on the licensee board here in Massachusetts and got to understand that doctors take practicing medicine, very personal and they take criticism personal. It's not, we're not, even though the lawyer said, they're not criticism, it could be anybody. It's not you, we're not after you. It happens to be you, but the language we use applies to everybody. The horrible things we say about people, just as final lawsuit, what you did, what horrible thing, how negligent you were, how you didn't care about your patient, et cetera. I want, yeah, I have to say that knowing colleagues who have been sued, it's not just that. It's also the, I think, and this gets to part of Bob's question as well, the fact that our colleagues are very unforgiving. When people hear that a colleague has been sued, there's this sort of, I don't want to go near them, it might be contagious type thing. So there's a lot of social- There is some of that, I'm just saying that's so hard to believe, but I believe- There is a lot of social peer pressure, really negatives that happens when somebody gets sued, even if they did the right thing and you're going to get them off and everything else. And that's, which is why his question has that double layer of is it- Which is remarkable in that they have no respect for lawyers. I mean, lawyers who sue doctors, they hate lawyers who sue doctors. And so that they would let the lawyer take out one of their colleagues like that. I mean, I certainly see it, if you're sued multiple times, there's something there, you don't get sued multiple times. Most doctors never get sued, so they can be whole year than now and say, oh yeah, you got sued, so you're not as good as me. I don't get, anyway, it's a problem. Medical malpractice is a problem. I think anything we can do to make the experience better because that's supposed to be, we're not supposed to punish you. It's not a criminal thing. It's not to punish you. It's to compensate the person who you injure. It's to pay for their injury. That's what it's for. Only secondarily, is it any kind of a quality? So this conversation led to a lot of comments. One of them was asking, wasn't Dr. Poo personally sued in civil court? And do you know the status of those cases? She was, but only after the criminal case was dismissed. And I don't know the status of that case. It should be easy. I should have looked it up before today, but I'm sure it's on the internet. And then an anonymous attendee said, I believe the contingency payment model for barristers in America contributes to the huge volume and high insurance premium for medical practice. This commission-based barrister compensation model is something America takes for granted, but it's illegal in many other jurisdictions. Do you think that has something to do with it? It does. The reason we have, I don't have to tell you this. The reason we have the contingency fee system is to protect patients. That patients can't afford to bring the lawsuits. Injured parties can't afford to bring lawsuits. Is it problematic? It can definitely be problematic. I mean, I don't think you have to get a third of a million dollar verdict. I think there should be limits on how much that attorney can take from the final settlement. On the other hand, we had so many poor people in this country who simply couldn't even think about bringing a lawsuit. No matter how horribly they were injured, that you need some mechanism that permits them to get their day in court. And this is the best one that we have, but yeah, does it have problems? Yeah, it does have problems. Great, Mark, do you have any last questions or words of advice? Because otherwise we've gone through our chat session. Oh, the other big problem with malpractice, and you know this, is that you have to be really badly injured to get a lawyer to take your case. You've got to be in the million dollar range, or it's just not worth it. Mark, you're on mute. Mark, you're talking to yourself. Sorry, sorry. Can you hear me now? Yes. Thanks. I love the talk, and the talk went so beautifully with the title of the talk, which I forgot to say when I introduced you, George, but correct me if I've got it wrong. The title that we had was Double, Double, Toil and Trouble, Misunderstanding Standard of Care. That's it, you got it. And there's been a long time since I read Macbeth and heard the witches say double, double, toil and trouble warning Macbeth that as he continued to kill people in order to become king, he was going to get into trouble. And the issue here is that that's not what doctors ought to do to make their success, that is to kill people on their way to success. And the witches knew that it would not work out well for Macbeth, and I think that applies also to doctors. All right, very nice. All right, on that note, I want to say thank you on behalf of all of us here at McLean Center, and those from around the world, we actually had comments from people from Pakistan, as well as other parts of the globe. That's great. The beauty of doing this on Zoom is that we can have a much more international audience than if we were all in an auditorium. So thank you very much. I know the fellows will be resuming at 1.30 with Professor Anas. Anything else I'm supposed to say, Mark? No, no, that's good. All right, thank you very much and we'll see you all next week. Thank you. Thank you. Thank you, George. Bye-bye. Thank you.