So I have a big question for you as dean of Harvard Medical School what would you say to patients and even some politicians who assert that everybody has a right to try experimental unproven therapies before they get FDA approval I'm Insoo Hyun, a bioethicist and philosopher and Director of Life Sciences at the Museum of Science today my guest is George Daly dean of Harvard Medical School and a renowned stem cell res researcher today we chat about patients right to try experimental therapies is it dangerous is it the right choice for patients well George it's wonderful to have you thank you for coming um we've known each other for quite a while but uh you've been deemed for the last few years and that's been a big change you know after having been a scientist and a clinician uh also involved in uh public policy to some extent where we've we've interacted extensively uh it's a it's a sea change it's a very very different set of of responsibilities you and I have done lots of work in the policy area for stem cell therapies and translating basic stem cell biology and discoveries into patient cures um so we all know about the hype around that there are ways that exciting new developments can get to the uh the the public so to speak the patient population in the right way and there are like bad ways where that happen happens there has been a phenomenon called stem cell tourism over the last several years and could you just explain to our audience kind of what from your point of view what that sort of encapsulate that phenomena what do you think is going on there stem cell tourism is uh something that uh really embodies this notion that um patients will travel any distance they will U pay any cost uh they will um really accept almost any risk if it carries with it um the possibility of the relief of suffering MH and that's something that's been uh played upon um for the for for Millennia I mean they're going way back to the snake oil salesman MH the idea that someone is offering you a miracle cure is incredibly engaging and it's unfortunately also uh subject to you know very very perverse distortions of the The Physician patient relationship or the the relationship that any vulnerable individual has with someone who's offering them hope for uh for for a better life uh and so what what has been a problem for stem cells in particular and I don't think stem cells are any different from any of the prior waves of supposed miracle cures whether you know we can go back to leat tril and all the treatments for cancer it's simply praying on the vulnerable this and and that's the sad reality and ins it's something I know that we've uh worked on together it's something that you've got tremendous expertise in as well and I've been deeply deeply profoundly influenced by paper that you wrote on the notion of spiritual distress the idea that patients are seeking something that we don't often have an answer for in modern medicine so you were the one who came up with spiritual distress I mean I I I where where did you think of that and when was that something that you had felt yourself that that's that was an interesting paper to write because uh first of all I got it into a scientific journal it had the word spiritual distress in the title and the editor said what is this cell it'sing Journal you're right and so I got the idea in the following way I was answering emails from Desperate patients even I got emails not let Al like clinicians and some socities I know you get emails all the time from Desperate patients I got emails and one person said you know this is a person in Italy he said my son has got a degenerative brain disorder Dr Ken I'm thinking of taking him to a clinic in Moscow and I'm thinking oh my gosh I hope it's not that clinic where that Israeli boy got tumors in his Central nerv system from fetal stemell transplants but anyway he said I'm thinking of taking him to Moscow what do you think about that idea and so I answer the way I normally answer those kinds of emails I gave information and I even attached the international Society uh handbook for patients that we helped develop and uh and I normally answered in the typical way of here's information and I thought you know what I'm going to do something different this time I'm going to do something i' hadn't done before I I typed at the very end of that email if you're asking me what I would do if if I were you I wouldn't go to Moscow with my son I would spend whatever time I have left doing what he wants to do hit send and that was the first time I ever got a response from somebody the next morning he emailed me back and he said Dr Ken I was afraid you you were going to say that but I think you're right and I was thinking about that for a while and then I ran into the chaplain at University Hospitals in Cleveland and on our way to an IRB meeting he asked me well how are things with you what's going on and I told him what happened with this email and he was the one that said oh yeah that family is in spiritual distress and I said well what is this that's an interesting notion he told me oh yeah oncologists and uh pediatricians people and nursing people have written about this phenomenon of people falling into a kind of spiritual distress where they lose meaning you know and like looking forward to the next day they start losing hope and the antidote for Spiritual dist distress is this kind of therapeutic hope pinning your Hope on kind of like the Hail Mary right and I was really fascinated by that Dynamic so I looked up you know that literature and I thought this is really a missing element to the stem cell tourism phenomenon everybody thinks that the way you have respond to this kind of desperation is give people more information but what if the people don't need more information they need emotional support or some other kind of social support and so I wrote the paper basically making that point and uh and I you know I think that's that's a pretty highly cited paper for that kind of bringing that new idea from other areas of medicine into kind of the stem cell discourse traditionally Physicians haven't been taught or it's thought not to be scientific to appeal to these Notions of spirituality or right to to to meet the needs of patients when it can't be delivered in the form of a pill or a surgery or something like that there's a wonderful book written by uh Jerome grman Jerry grman who's a physician who who hematologist oncologist who was obviously cared for many many desperate patients he was one of the leading figures in the in the early AIDS era but he's written a book called the anatomy of Hope in it he describes the distinctions between false hope which is the problem that plays into patients vulnerabilities and and makes them subject to the the siren Call of these um these folks who are offering false hope and and contributes to Stem Cell tourism but what you what you really want to convey to your patient is true hope and and that doesn't always mean I have something in my treatment armamentarium which is going to cure you I can't necessarily give you the false hope of cure but I can give you true hope about things that address the spiritual needs the personal needs of comfort and and and interactions with loved ones right um you know as a hematologist oncologist myself I've had many conversations with patients where one had to talk about the tremendous relief of suffering that doesn't come through medicine but comes through spirituality yeah and just to be clear by spirituality we don't necessarily mean religion some people get spirituality through religion other people get it through the connection to Nature or to the Arts or music to one another to family to community so spirituality is a broader notion than just a religious Doctrine in fact the chaplain I I had mentioned he told me and see you know in my 20 plus years to being a chaplain in University Hospitals do you know how often religious Doctrine came up in a conversation with the patient he said maybe five times what they want is they want someone to sit down with them hold their hand say okay what do you need uh that's spiritual care um so I I'm really curious are there efforts at Harvard Medical School to kind of get a little bit more of that into the training of future doctors yeah uh there seems to be uh an uptick in interest in the nature of Medical Training there's a bit of a tiate underway by this organization called Do no harm that seems to think that somehow we've gotten away from The Core Curriculum of medicine which is biochemistry and P anatomy and pathology and all of that because medical schools have introduced Notions of the social context of disease the social determinance of Health the critical interface of spirituality the appreciation of structural racism as an element that contributes to disease and the like now of course medicine continues to accumulate information uh it becomes increasingly impossible for any single individual to absorb and and and be able able to even manage the huge onslaught of information I mean if we use the metaphor of drinking from a fire hose I it's like this is a waterfall you know and and yet it's absolutely essential that our students receive an education which isn't purely the sort of basic science of medicine and disease Physicians practicing today have to understand the social termines of Health think about co co brought out in Stark relief the interface of poverty overcrowding lack of access to medicine and the burdens of the uh of SARS K to so medicine uh as a I mean medical education has had to evolve and it's it's a challenge but we have to understand how we can prepare our students to be not just scientist but compassionate and and and [Music]█ █ empathetic so we're at Harvard Medical School and this place reminds me of Starfleet Academy George and you're like Captain peard ushering in the next generation of science Learners scientific explorers and doctors I'm wondering you went to medical school here and how much has the medical school changed since you were a student I would say the the change has been dramatic um it's still the same great fundamental education about anatomy and physiology and all but medicine has progressed at such a lightning pace so much more information now that the students have to integrate and especially all of the social context of medicine the social determinance of Health you know we saw in the co pandemic that that was every bit as important in understanding the ravages of the virus as the anatomy of the molecular Corona virus um so we now have uh education on the sort of cultural context of disease uh we think about issues of Health Equity and social justice those are equally as important is anatomy and physiology and biochemistry but it makes for a very crowded curriculum right well it must be amazing to see that change in the institution from your time here as a student and now as Dean but those are just such important topic areas I'm so glad that you're putting a light on those it's a deeper and a richer education another major difference between when I was in school and today is the use of educational Technologies for instance we now incorporate a lot of simulation I mean you know when air pelling Pilots are learning they're ideally not learning in the cockpit they're in a simulator and now we have our medical students doing important interventions in a simulated setting where they can be observed they can be critiqued given feedback without having a real patient put at risk so that's a major major Advance we've also Incorporated a lot of Technologies like um virtual reality augmented reality and we anticipate that that's going to become an even more minent in the future so this really is like Starfleet Academy this what you're saying well who knows where it's going to be 150 years from now I'm glad you brought up the co experience because in a lot of ways that also shined a light on um patients access to experimental therapies things that have not been yet approved by the FDA we saw that in sharp relief during the co pandemic now just so our viewers understand the FDA already has a process in place since the 1970s called expanded access that gives patients through the recommendation of their physici access to therapies or drugs that are in development they're in the pipeline they're in the sort of a FDA clinical trials process but have not yet been approved by FDA this is a a groundbreaking approach you know you you have to get permission obviously from the company developing the drug or the product of course so with their permission FDA can allow the release of this investigational product just for you know a few patients or a small group of patients um who have a very serious medical condition now apparently there are groups of people who are unhappy with that policy they don't think it goes far enough and so now what you've seen since 2018 we've have the uh Federal right to try act so they call it the right to try and um patients have driven this but actually mainly politicians have driven this at the state level but now there's the federal policy and so what this policy says we're going to sidestep entirely the fga and in some ways okay that's more liberal but in a lot of ways it's more strict than the original expanded access policy because it's for people who are about to die so it's not just seriously ill but like on death's door so it's more stringent that way and it's only for individual patients one at a time you can bypass the FDA and get direct access access of course with the company's approval so the company he stole the gatekeeper um so there's been great interest in this idea of getting your hands on the latest greatest if it's at Harvard Medical School or being developed by people in spin-off companies from Harvard Medical School they must have the greatest newest thing I have a big question and that is as dean of Harvard Medical School what do you say to patients and even some politicians who say individuals have a right to try meaning they get access to um a whole host of investigational unproven therapies without any FDA input do you think there's such a right to█ █ try this is such a complicated question and I wish there were easy sound bites right to try is itself a very seductive easy sound bite I just want to give it a shot I want to have a I want to have a chance I want hope and the problem is is that so much of what d right to try is the false hope it's not true hope you talked extensively about the FDA and the FDA is it's a punching bag it's easy to criticize the FDA I happen to have worked closely with many people within the FDA I can tell you they are just as eager as as anybody to approve um breakthrough medicines to make sure that they pushing the envelope and doing it as fast as possible but they also understand how difficult it is to find a new medicine that really works it's hard work Harvard Medical School knows that our whole Community is devoted to the idea that we need to discover new elements of biology we need to translate it into the development of new medications and we need to be able to introduce it into patients safely and effectively and that often takes years if not decades but the problem is people are desperate people are vulnerable people are sick and they want a chance at something and the problem is it's it takes longer to explain why there are risks inherent in trying something I've seen patients who have been desperate they've been at a terminal stage of their disease and they've tried something which has accelerated their demise and exacerbated their suffering it doesn't come for free it comes at a cost and a risk and I'm particularly concerned because I'm at Children's Hospital the number of times parents will take that risk for their kid that is particularly Troublesome because when it's when it's a condition that I know really cannot realistically be helped by whatever stem cell intervention or or snake oil might be being offered I know that the risk of pain and suffering is worse and and it's it's a desperate situation well I'm glad you brought up the point about pediatric cases because often that libertarian argument about this is the patient's body this is their money let them do what they want with it works best if it works at all it works best when the person assuming the risk and making other decisions is the same person right but what if and is capable of making thoughtful and informed decision that's right right but in in other cases in many cases is parents that are desperate and they're seeking a cure for their very young child which is troubling because it could actually make their condition worse or or but there's another element even even for well-educated uh sophisticated patients uh it's very difficult to be certain that they understand the risk and benefit there is this tendency you've taught me about the therapeutic misconception which can undermine the the Integrity of clinical interventions attempts to test whether a a a drug or a treatment really works and we say to the patient you know you have to know that you know this could be risky and it may not help but often times that patient carries the false hope and it leads to a therapeutic misconception and they're willing to accept risk maybe they're not perfectly well informed you know you had mentioned false hope and and real hope there are other really fascinating dimensions of hope that I think are at play here so some of the literature that I read in preparation for the article that I I wrote on spiritual distress and and Hope hope is very active in for patience so it's not like a Wishful passive like thinking you know I I hope someday I'll get better but it's very active so in that case Hope Has a a certain structure number one you have some goal in mind right I want to cure I want to amarate my condition or I don't want to be a burden on the family so you have some goal and then you identify a pathway to that goal that's step number two and then number three is I am empowered to follow that pathway is within my range of power to do so and so you get those three elements if you knock away one of them you better replace it with something else otherwise you might fall into despair or they they'll seek another Avenue so if the doctor just says to their patient oh don't go to Moscow it's not going to work you know so they they close the pathway you better open up another one you better say well what really is your goal if you don't want to be a burden let's explore other ways that you can be empowered to follow that especially parents they don't want to feel like they're just giving up on their child like they feel like I have to do something so it's that kind of like self-activation part of it it's not wishful thinking it's it's it's it's goal-seeking and pursuit super intentional right yeah um and so that in some ways it's almost like an indictment against some traditional medicine or even doctor's relationships with patients that they're not getting that kind of they're not getting fed that um that desire for like being actively participating in control of what's happening to them and that's that's that's that's the fear of losing control I think I think we have to remind ourselves that medicine has had its Heyday in the last century or so um life expectancy is more than doubled since 1900 and it's in large measure because of Public Health um interventions clean water vaccines um antibiotics certainly uh we we don't have uh the the burden of um infant mortality that we used to have and all of that is wonderful and medicine is progressing at an enormously rapid pace and yet it feels like it's it's almost getting more and more difficult to get the breakthroughs because we really have a rich and mature medical system so it's really important for patients to understand how difficult it is and how unlikely it is that somebody can simply say oh I know this works let me give it to you and it's that kind of anecdotal oh I've seen it work I've you know trust me it's going to work that we saw at you know happened in the early days of the pandemic I mean people were desperate for some intervention that would that would cure the patient patients were dying and and they were willing to listen to things like oh chloroquin must work Ivermectin must work x y z and the reality is when we when we subject these anecdotal sort of observations to really rigorous blinded randomized types of analysis icin doesn't work chloroquin doesn't work we have to be humble as Physicians and we have to be receptive as as patients to realizing how difficult it is to prove that something█ █ s so when the general public thinks about medical professionalism their thoughts immediately go to the Hippocratic Oath but you and I know that the Hippocratic Oath is so outdated right because it says thousand you're not supposed to teach women the Medical Arts you're not supposed to charge tuition you're not supposed to use a knife we know there are knives all over the place here HMS well they cut out Stones right that's I i' never seen a bladder stone but you know so so people this idea that people doctors at graduation give an oath to society it's not the hypocracy here at Harvard Medical School do the students have their own oath that they offer at graduation they do they do in fact there's a whole committee that works on uh the construction and the uh sources ideas from lots of other students and they read it collectively with us sort of leading the the uh the oration uh at their graduation ceremonies yeah so it's an oath that uh much more modern than the Hippocratic Oath we aren't swearing to any healing gods or anything like that but it it really espouses the standards of professionalism the the Deep commitment to selfless service um the critical importance of Health Equity treating everyone without regard to their status and deep deep principles of medical beneficence and non maleficence patient integrity and confidentiality I the principles are the core ones that should drive the professionalism of all Physicians right well what the two elements we do so key from the hypocritic of is to do no harm and to protect patient confidentiality but I think most of the rest of it we could do away with and adopt more modern standards that's absolutely right uh I think this issue of Health Equity it dovetails with the changes in our medical curriculum as well the students understand and appreciate that they are ad Advocates and agents of change to achieve one of the highest goals of medicine which is to deliver expert Compassionate Care to all can you give us an example maybe from the stem cell field of of how challenging it was for a success story to be a success story um you can even get a little bit into the weed shirt because I because some people might just say oh look they're just being way too negative here there you know but but no there are some great technical details about why we have to be so careful yeah well in my own field of uh htic transplantation bone marrow transplantation that takes us back to the 1950s to some very pioneering studies done by Don Thomas he had the notion that patients with leukemias and lymphomas were it was a death sentence and we knew that uh at the time because of tremendous interest in the impact of radiation and the aftermath of the of the nuclear bombs in hosim and Nagasaki we knew that radiation and certain kinds of chemotherapy could Wipe Out the bone marrow and it could Wipe Out the lukemia what Don Thomas discovered was if you have leukemia I could potentially cure your leukemia but I have to I I would give you radiation and chemotherapy I could eradicate your leukemia but eradicate your normal blood forming system as well but I could transplant the blood forming system from a sibling into you and it might grow and take and we could have you survive well the the first 10 or 12 patients that he treated all died a terrible and painful death and it was actually Don Thomas himself who realized I don't know enough about the biology to make this work I've got to go back to the laboratory and he did he went back to the laboratory started doing experiments in dogs and then discovered this idea that we actually had to have tissue matching you know randomly occasionally your sibling would work because they have about a 25% chance that they match your tissue but then he could do the extensive tissue matching started to do human clinical bone marrow transplantation and became successful and won the Nobel Prize MH now it's 70 years later mhm 65 70 years later and this is among the most successful stem cell therapies we can treat and cure not in all instances we're still doing research but we can treat and cure leukemias lymphomas genetic diseases of the blood and bone marrow but it took Decades of painstaking effort lots of failure lots of death but it's now in place we hope that modern medicine is quicker than decades but in many cases we have to do the hard work you know I should point out to the audience that there are actually two big roads to the clinic uh for new new Innovations one is through the clinical trial system FDA oversight and all that so you got Tri you know phase one 2 three Etc then there's also medical Innovation outside of a clinical trials context so a lot of like off label prescribing of medications have developed that way um Surgical ation have developed that way so it's not through a clinical trial system but um trying to do the little tweaks on patient care and over time you get clinical experience and it's it becomes proven what do you think should be a responsible way to do that second route right the the medical Innovation route so Harvard Medical School is a massive medical innovator are there people there that kind of take that other route and what do that other route looks like medicine has had a you know a history going back thousands of years and and uh a huge part of medical history is really about diagnosis and prognosis it's only been rather recent that we've been able to have a real impact in Therapeutics in actual interventions that change the natural history of disease so what you're positing is you know we haven't gotten there just by all clinical trials there's been a lot of medical intuition there's been a lot of observation you know people chewed on the bark of a tree and they figured out that my God their fever went down and their pain was relieved well we later knew that was aspirin right and there were uh it was a deep history of herbal and and um natural products that were drugs the Chinese pharmacopia is is thousands and thousands of of um natural chemicals and herbs and things you know so much of medicine has actually evolved through careful observation of disease um trial and error uh approaches to uh treatments um and not all has emerged through this very rigorous clinical trials pathway and yet we've also been we've learned through many mistakes that anecdote and trial and error is error prone uh there are many examples whether it's uh you know hormone replacement therapy for postmenopausal women thinking it would reduce cardiovascular disease and and the like anecdote and observation while it can lead to Medical Innovation is also fraught with error and so as much as possible when we do medical Innovation it should be done with um informed consent for the patient it should be done on a small number of patients and only after there's a reasonable clinical hypothesis that my intervention and my observation suggests that there's a a positive outcom that we should move from this purely medical Innovation Pathway to something that would be aiming at creating a more generalizable knowledge that can be evidence-based and can be promulgated to the masses that's why the clinical trial program is is sort of been█ █ estad you know the word profession and professional has so much weight but you can't just use it willy-nilly right there are people who might want to say I'm a professional carpet cleaner and they'll put professional on the side of their truck but the real professions the original four were law medicine Divinity and Academia and when you think about those four original professions it was really meant to be in service to a very important societal need the legal needs of a society the spiritual needs the medical the knowledge needs so you can't just call yourself a profession and just be a profession just because you want to so this idea of you know a profession being a service to society is still one that I hope we can we can remind people of and I think as you would agree medicine continues to be that calling it's it's a service to society it's not just a way to make money in fact you know Plato very famously once wrote that as soon as a doctor trains his or her mind on making money he functions as a money maker and no longer functions as a doctor I think in its highest aspirations medic is a calling and indeed um nowadays there are a lot of other ways that uh the top college graduates can go on and and make a lot more money Physicians still do extraordinarily well but they're no longer at the top of the economic food chain but the core Drive of the best physicians is still the desire to help others and they do feel it's a calling I think it's it's it's a deep and and respected aspect of the profession you're there for the service of your patients now we know that medicine has many faults and many um foibles and those ideals are sometimes not met but the physician should be treating the patient without regard to patient's ability to pay we know that that can be corrupted it should be in the best interest of the patients at all time free of the conflict of interest of the physician's own needs that means that you know in Tradition Physicians have been on call sometimes 247 if they get called out in the middle of the night or um interrupted from a family event they're there for the service and we saw during the co pandemic that not only Physicians but nurses and other Hospital staff were putting their own well-being at risk of going in and meeting that call for service and I think back in the day when medicine was first starting out there was much greater risk of dying from Catching diseases from your own patient so this idea of it being a calling can be a little bit easy to forget over time because we normally are not in these pandemic like situations but it really came out in the in the past few years absolutely many of the Health Professions Beyond uh Beyond medicine uh you know as you mentioned nursing the respiratory therapists the folks who were really on the front lines during the pandemic they showed their medal because they were there for the greater good of the community and the patients in front of them the patients they cared for patients whose lives they saved that really I think reminded us all of the importance of this as a calling I think that some of the people who provide these fraudulent stem cell therapies and cin cells doctors in these clinics providing fraudulent stem cell-based medicine to the patients are actually turning their backs on the oath of the profession and on the commitments that all doctor should make toward the best interest of their own patients I think if you if you focus on what are the core principles the ethical principles that guide The Physician a lot of these uh stem cell clinics these practitioners who are pushing snake oil and unproven interventions they fail they fail necessarily on acting in the patients best interest if they're offering unproven and often times faulty kinds of interventions especially if they're if they're charging for them and they know they're unproven the money maker bit of that's exactly right this is this idea that their their own Financial conflict of interest is not in the best interest of the patient I think it's one of the core principles of of medicine today that you practice evidence-based interventions and if there is no evidence then of course in the realm of innovative care or experimental medicine there are principles that guide the use of that as well the patient who's receiving that should be well informed and they should know the risks and whether there is any potential for benefit oftentimes there it's unknown and they should be able to give their informed consent and in many instances these unproven interventions really take advantage of the patient's vulnerability they may say they're giving their consent but they're fundamentally under operating under a therapeutic misconception we've talked about this before well when you think about the original professions there was always a need and you had a vulnerable population that was being served people who couldn't defend their own legal interests people who didn't have the knowledge to advance you know medicine or Advance other fields so it was on the responsibility of the expert to look after the other person's best interest that's why you can't just simply call yourself a profession just because you feel like and want to make money it actually has to have that power IM balance and a responsibility that comes with that power and balance absolutely there is an asymmetry of knowledge there is an asymmetry of power if you say and so it's up to the physician to take the personal responsibility to act in the best interest of the patient and when that happens it really does elevate medicine to the to the highest ideas to a calling I want to conclude with some thoughts on medical professional ISM and just to get back to the right to try terminology I don't even think it's well named it's not right to try it's right to ask you have a right to ask your doctor for help you have a right to ask the company for access to their investigational product by which by the way apparently very few companies will allow access outside of any kind of FDA involvement I mean they're trying to get FDA approval do you really think that these companies are gonna tell the FDA well this time we're going to go around you and help these patients so to speak and then we'll come right back to you and seek approval that's not a very good relationship you want to build with the FDA but in any case there's a right to ask and I think typically the answer to demand maybe is another way to think about it right but but rights come in different flavors in philosophy we call them positive rights and negative rights the negative right is the right with to pursue something without other people interfering so minimally it might be that kind of right I have a right to like try to do something for myself without you interfering but what we're talking about here is medical therapies that's a positive right that's a right to something to somebody's help to have somebody provide you with something you want those are very different types of rights in the positive right realm I mean that involves medical professionalism medical Judgment of the doct treating physician they have to agree with you it has to be a shared decision between you and the doctor that this is really in your best interest and given the track history of how very few people have actually use the right to try why whether it's the federal version or the state version I think a lot of doctors are saying hold on a minute maybe this isn't a great idea or the companies will say we're not going to give you access to this stuff before FDA approval we want to get FDA approval we don't want to get in trouble down the road so um medical professionalism I think could be kind of a protective right a little bit right to to to Tamp down ideally some over enthusiasm by the patients or demands by them unrealistic expectations how in the medical school context do you think you teach the students to become professionals when they leave how does that transition happen I take great pride in our educational system we are really fortunate that we recruit and attract outstanding Earnest students who want to be committed to a life of service service of the patient and what we do is we Empower them with this enormous fund of knowledge but they have the responsibility to use that knowledge in the service of their patient and the patient physician patient relationship is one of trust um and it's one of protection yes because there's an asymmetry of knowledge here and as we've talked about with the right to try or the therapeutic misconception um often time a patient who's in a vulnerable state may not be as discriminating in their thought process they may not be able to judge the risks and the benefits they may out way one or the other and it's a physician who's charged with being a steward of that process MH now when it comes into the realm of an actual clinical trial then you have an even more elaborate oversight mechanism you have an Institutional review board which sits and reviews the protocol and determines the risk benefit kind of analysis and then when it gets to the federal level we actually have a Food and Drug Administration which is charged with protecting the patients and making sure that we have safe and effective medicines on the market I think it's a system that works but it does all come back to the fundamental trust that the physician and the patient have together well I think you have some really unique insights here given your track history of just being an outstanding researcher but also a compassionate physician and now a leader in medical education so thank you so much for joining us today privilege into you thank you█ █ [Mu]