Medicine X 2017 Keynote Presentation: Hooman Noorchashm in conversation with Gilles Frydman


Hooman we met a few years ago online after your wife was diagnosed with leiomyosarcoma and you join one of the online communities I was involved in that’s right yeah we after Amy’s diagnosis we joined a core which was probably one of the largest lms communities out there and it was pretty obvious from the beginning that there was something special about your story so can you give the audience some background about who Amy and you are we’re absolutely yeah Amy was a an anesthesiologist and intensive care physician she early on had been our high school valedictorian had graduated Phi Beta Kappa golden key from from college went to graduate school at the University of Pennsylvania got a PhD and an MD and then subsequently trained as an anesthesiologist and an intensive care physician and ultimately joined the Harvard Medical School faculty I sort of took a parallel trajectory I did a combined degree MD PhD at Penn did my general surgery residency at the hospital University of Pennsylvania Philadelphia went up to Boston for my fellowship and in 2013 I joined the faculty at the Brigham and Women’s Hospital and Harvard Medical School you were a successful couple you could say that we they’re a success we we were flying at 30,000 feet oh yeah it’s disaster-hit what were you thinking of patient activism at the time well you know I you know I thought I thought about this a lot because you know a lot of folks look at us and say you know you’re your patient at them you know activists now you’re a patient safety activist and I you know I would have liked to think of myself as an activist when I was a physician I think every physician should be a patient activist by as a safety activist ethics activist by definition but but I do think that that ends up getting lost and you know I think a vast majority of physicians are sort of schooled in an ego and and then call her cultured frankly to look at patients or angry or disgruntled as you know crackpots if you will for lack of a better term and I think that that is a pervasive culture and particularly procedural oriented specialties like surgery so I think you know my view of activism dramatically changed I mean I can tell you that a lot of folks have accused me and my wife of being activists so being emotional but I can tell you that yes this was a campaign of emotion but it was also a campaign of science and ethics and I think the results speak for themselves sure so much was covered in the video and audio presentation you have anything to add I think they pretty much captured the the picture you know I think fundamentally the message that I’d like this audience to capture is that is that things do go wrong it’s a complex system and when things go wrong it’s absolutely essential for the system to be able to capture these problems I think ultimately and as in any engineering system you test the system has at its extreme so it’s fine to put slogans with patient safety and claim that were ethical physicians but when their actual test comes you know if you fail that test then the system has failed and I can assure you that the Brigham and Women’s Hospital and Harvard Medical School failed this test pretty miserably can you remind us how many years the power morcellator had been used in gynecology yeah to remove fibroids prior to waiving surgery well well the practice of more solution has been in gynecology forever it actually remains in moreso in gynecology currently the power morcellator was simply a sort of a mechanization of that process and the first power morcellator came into being in the early nineties and in fact john camp from The Wall Street Journal did a quite a nice and extensive coverage of this in terms of the history and evolution of the power morcellator and how was approved through the FDA and how went into use but yes it was about 20 years that this device was in use by 2013 some were close to fifty to a hundred thousand women or you’re going oscillation operations and it turns out that one out of 350 of these women were at risk so it’s fifty two hundred thousand every year by 2013 and and it was actually on an upslope at that point so the projections were that you know the hope was that every woman would actually undergo such an operation so after 20 and some years of further use of this power morcellator how many cases of leiomyosarcoma had been reported to the FDA by surgeons prior to Amy’s diagnosis well I’m gonna rephrase your question so how many cases of leiomyosarcoma more slated leiomyosarcoma had been had been reported to the FDA is the real question and the answer to that is according to the FDA’s investigation internal investigation and the Government Accountability investigation zero Ami’s we can repeat this zero no no gynecologist no hospital had bothered to report the oncological complication associated with more solution to the FDA with the use of a power morcellator to the FDA no individual physician no individual manufacturer no individual hospital and I think everyone in this room hearing that I think should be infuriated by that that is a that is a catastrophic failure if you asked a doctor a surgeon what was the risk associated with the use of the power morcellator what kind of response would you get well you know to be clear most gynecologists up until 2013 when the Wall Street Journal started covering this were considering this a minor technical detail of the operation so just like a cardiac surgeon doesn’t inform the patient of what kind of suture they’re going to use the gynecologist most of them did not bother to inform women that the power more solution was happening so literally you know this this was a modern-day monster you know so you’re a woman you go and you get offered this operation and yeah you have an occult er missed contra more slated your cancers upstage the answer is well sorry ma’am you have a bad cancer now and that’s that so these women were falling through the cracks for 20 years and no one would hear their voices and it’s as simple as that it’s a modern-day monster can you explain how is that possible well I think that our system our healthcare system is on this what I call this utilitarian train you know we’re so much about creating efficient system service lines and I think the cost of that utilitarianism what we jut what we do is we justify utilitarianism these service lines that we create under this you know rubric of informed consent and we forget to step back and ask ourselves about medical ethics certainly in the case of oscillation there was a serious violation of surgical principle at work I mean you know it’s a fundamental surgical principle that if you have a tumor and it has malignant potential you cannot you should not disrupt it inside a patient’s body because if you do it spreads cancer it spreads this tissue and that’s just an incorrect practice and I think somehow this had entered into the garner gynecological silo and had been accepted as the standard of care I think it frankly speaks to the lack of the liberal surgical education on the part of gynecologists they trained in a silo and you know they’d missed it there is no definitive way to rule out an early stage malignancy in any woman with symptomatic uterine fibroid right I mean you know and therefore and therefore you know if you if you can’t tell if a tumor is cancerous or not and a procedure definitively has a risk of spreading that cancer then you should not do it period it’s it’s it’s a fundamental violation of the principles of non-maleficence and medical ethics and justice and if you do it and you justify it on the basis of informed consent or worse yet if you justified on the basis of majority benefit then you’ve become a utilitarian with unhinged ethics and I think that that’s fundamentally what the sort of mechanistic basis of this is is I think we’re looking at an example of medical utilitarianism dysregulated where with you know I opted in operation without medical ethics sort of regulating it yeah this brings the issue of the impossible informed consent yeah can you say something about yes I mean we’ve thought about this a lot and then you know you and I have talked had several conversations about it look informed consent goes as follows right if you’re and you’ve you’ve basically been told let’s say about the risk of morse elation that could spread cancer but oh you know don’t worry you don’t have the chances of you having cancer or anomic Lee small you don’t believe you have cancer if the doctor is offering – knowing that the more solution could spread the cancer the doctor doesn’t think you have cancer but if in fact you do have a cancer right that informed consent form does nothing to protect you it might protect the doctor in a courtroom but you know I’m not even sure at this point it would so I think it’s basically just sort of a device that we use to sort of rationalize and make ourselves comfortable accepting these utilitarian practices under the rubric of a majority benefit so you know when and when people talk about well this thing benefits the majority the question is but what about the minority are we exposing the minority subset of patients to an avoidable harm and in this case yes this was an avoidable mortality risk so we shouldn’t do it period we might even say that they seen from consent if the doctor strongly believes that there is no cancer and of course I don’t know if any natural normal person who without being diagnosed with cancer thinks that they are have died they have cancer so it may even give them a false sense of security in the air of legitimacy false sense of security absolutely you know yeah you’ve signed the informed consent form you know the patient knows everything and I’ve told them everything and in fact the Brigham’s first response to us to our campaign and to the wall street journal was that we’re gonna change our informed consent policy and the immediate answer to that suggestion was how in God’s hell is informed consent going to protect the next patient who’s going to come across this problem and that is a colossal leadership failure at Harvard Medical School at the Brigham and Women’s Hospital at our most prized and sort of respected medical institution yeah going back to the lack of reporting priors to Amy’s case is there any legal requirement for physicians to report adverse outcomes associated with medical devices so you know Amy and I did a lot of work with this and we were very fortunate to collaborate with several congressmen with senator Elizabeth Warren with Senator Casey with congressman Fitzpatrick and and you know i can tell you with the of certainty here individual practitioners expert practitioners have no legal requirement to report problems with medical devices to the FDA none class spittle will say this again yes individual practitioners me as a physician I have zero legal responsibility to report an adverse event associated with the use of the medical device to the FDA period that’s the law hospitals do manufacturers do yeah so there is no legal requirement what about ethical requirements so as a result of all this you know we ended up doing a lot of reading and in fact you will find it astonishing that if you look in the AMAs code of medical ethics opinion number 9.0 3 2 I would welcome all of you guys to get on your devices and search that now opinion 9.03 2 very explicitly states that if a physician a physician comes across an adverse outcome a mortality risk and morbidity risk associated with the use of a medical device it is that physicians ethical responsibility to report that problem to the FDA it says it quite explicitly in those terms so yes there was an ethical failure clearly and still not a single case was reported for over 20 years correct that’s what the GAO says and that’s what the FDA says that’s 20 years of 50,000 to 100,000 which means that it’s at least hundreds of women and almost certainly many thousands it’s almost certainly hundreds if not thousands of women in the United States it’s certainly a lot more across the world because this practice is being used across the world and so yeah I mean you know we are you know again some people some Gynaecologists have sort of accused me and my wife of sort of being shock jocks if you will yeah we’re trying to shock people right but we are looking at a modern-day monster here this is like a public health problem right so remember look monster was that a man-made mom right look you know if a plane crashes here right now right what you’ll see is like 200 people dead or maimed right but if you know one woman a day two women a day here there San Francisco California you know Philadelphia New York are getting harmed and at the end of the year you have 2,000 women placed at risk or harm you don’t see that very easily right and but if you see a plane crash in front of you you know geez you know we should shut down the whole fleet but when equations need a proxy either with the doctors or hospitals to be the one reporting problems so if nobody ever reports a problem you end up with this disaster right that’s right and in fact you know a lot of patients actually knew that there was something wrong but I think the system sort of said well sorry you have a bad cancer but what do you mean you know my perfectly healthy wife or her mother came in for benign symptomatic disease and two weeks later you’re telling us she has this catastrophic cancer and two months later she’s gone right so a lot of patients actually when we started this campaign a lot of patients who came out they said we knew there was something wrong we knew that this is it’s impossible for this to be the case but the response was well no you have a really bad cancer and you know we’re sorry so we talked about the responsibilities of the doctors what about hospitals and manufacturers oh look the hospitals and manufacturers they don’t have a car or they do 100% there’s a legal requirement for the hospital for example the Brigham and Women’s Hospital was given a letter of reprimand by the FDA saying look you should have reported this you knew this and in fact the Brigham itself there was a very high-profile case before Ami’s that had happened at the Brigham and they did nothing about it they had they published the largest series on this complication yes we’re gonna cover this like initially so so clearly there was a hot failure on the part of the hospitals and manufacturers and and you know and literally I mean I think this this will be proven in court because everyone sort of denies you know it’s like you know everyone’s in CMA mode everyone sort of trying to cover their tail and and run away from this problem but the reality is the court system you can’t lie in court and and that’s basically what’s gonna happen it’ll be demonstrated these manufacturers and the hospital had information that that was necessary for the the protection of women’s lives in this particular case and they chose to do nothing yeah so human a me and you I think are the only piece of people that I’ve ever met that have been able to force the FDA to reverse approval of devices yes we’ve been accused of n of one policymakers by the New England Journal what do you think are the personal characteristics that to help both of you make this campaign a success well okay so look it’s a it is a complex anatomically complex campaign it was a campaign it had several very important pieces to it you know number one is that we Amy and I both had the language to speak about this problem very sort of scientifically and and in clinically digestible ways to public health experts so you know and we were we were we know to physicians at Harvard Medical School with with credentials to speak about this that’s number one number two the Priory was I have to interrupt you you have to remind people how long did it take you to figure out that the use of MRSA later when you heard that Amy had been diagnosed with cancer how long did it take you to figure out that the morcellator was the the the tool responsible for it well her gynecology I had a conversation with her gynecologist almost immediately after she called me and and you know I my response was well you know did you get it out in one piece because it’s sarcoma and that’s the only chance of a cure and she said no I’m won’t had to morcellator I said what do you mean Morse later so yeah we use the you use you know more slate things right and so and so then I knew we were in trouble and then on the way back to back home I was down at Duke at the time and on the way back home I just did a quick search it took me about maybe 45 minutes or so to figure out that there’s a device called the power morcellator the the largest you know manufacturer calls the device a guy Nick here morcellator which means it’s specifically used in gynecology so a general surgeon a thoracic surgeon myself would have never seen it and most of my colleagues had not heard about it and you know it took 45 minutes to figure it out it’s being widely used and a lot of women so I’m coming back constantly coming the information was out there the prior lack of reporting is just so unbelievably shocking once you understand what kind of data did you use to raise the FDA awareness of the risk associated with the use of the morcellator well there’s this very convenient government-sponsored database called pubmed govt you can type in any anything you like in there there’s a little search box there and it’ll pump give you you know results so they probably took you like months of work to find out it took me personally half an hour and then it took me about 10 more minutes to realize that the brigham itself had published the largest series on this internally and then again say again it took me about ten minutes no no the follow-up is the largest ever the largest study describing this very complication was done at the Brigham and Women’s Hospital where my wife and prior to her this is Erica Cates had been harmed and that time Eric occasion to study done by the the other by the very part Monteux gynecology that actually treated my wife what caused the risk in that study somewhere in the 1-1 and 400 to 500 range as well and when you talk with the same people when you talk to them they said well their response initially to me was was you know you guys are incredibly unlucky you know this was the gynecological oncologist who my wife had consulted to begin with and he said you know you guys are incredibly unlucky this is 1 in 10,000 is the risk unbelievable disconnect well I just you know I think that I think what was happening here is is there was a you know there was a cognitive error being made and that is that you know if you look in the general population the incidence of leiomyosarcoma is probably on the order of 1 in 10 to 20 thousands that’s correct but if you actually use the correct denominator which is the women who walk into the office with symptomatic fibroids the number there is probably about 50 to 60 times higher it’s one at one in 350 you know that’s that’s a number that the FDA has excavated many academic medical centers Columbia a Michigan Kaiser Permanente have have now excavated the risk of a woman having an occult malignancy with a symptomatic fibroid is somewhere in the range of one and two hundred to one and five hundred period now if you know the AGL and variety different gynecologists want to shed doubt on that as if it sort of ethically sort of absolves them they’re welcome to try that and they are trying that in courts all over the country but it’s not going to work yeah coming back to the data for the FDA you probably hired an army of specialists to do meta-analysis no I took it an army of one and armed well no it was it was clearly a couple of collaborators for sure yeah I took it to my good friend from medical school dr. Michael Pasha or low he is an expert in health literacy at BMC we were medical school classmates and I took it to him because I didn’t want to give it the air of you know sort of emotionalism if you will and as all academic study took through 2-3 years to do I took him about a week to review the literature and he didn’t really even do a meta-analysis he just reviewed the literature and put it in writing and he collaborated with a couple of doctors at dana-farber dr. Suzanne George and and they sent an article reviewing the literature with a number of one in 415 which was the initial number that they excavated to the England Journal Medicine so you send this data to the FDA and you got lucky a single senior person at the FDA decided to really listen to what you are saying well so yeah I mean it was our core is it was a combination of both doing our homework and and luck you know we you know I looked at the entire FDA leadership at the Center for Devices and radiologic Health Margaret Hamburg herself was the commissioner there and you know and I say certainly all got the information but the one person who actually got the information and immediately responded to me was was a dr. Peter Lorre dr. Lurie is comes from a patient advocacy background he was a leading member of the Public Citizen org and and Peter frankly listened about 45 minutes after I sent him the manuscript he shot an email to me I didn’t know Peter I you know he wouldn’t he didn’t know me from a fly on the wall and you know within 45 minutes the associate commissioner of policy and planning at the FDA shot me an email back and said is this published yet I remember when he was nominated many health professionals and organization complained about it yeah well he’s gone now so yeah in parallel to your efforts to report the extent of the problem to the FDA you also launched a campaign and try to find journalists and politicians and use of social media I suppose that all the journalists you talked to jumped on the story well not not quite in fact the first outlet that I took this to us was the Boston Globe and you know they they sort of they thought I was just you know making this stuff up how could this be right and and so they ignored us and then when the Wall Street Journal covered the article the the issue the Boston Globe came crashing through the door begging for statements so no it was not a walk in the park and we did get lucky we did have the correct language to use we did have some connectivity to folks at the Wall Street Journal so they just listened I mean they took it to their senior editors at the New York and they put some very experienced reporters Jennifer Levitz and John camp on this and they did a very serious investigative series that led to a nomination for a Pulitzer Prize to them so I think their their colleagues understood what this was and then there was a small but highly respected publication professional publication called the cancer letter yeah I decided to really cover this yeah well I look the cancer letter is a very unique breed of the media of the press and their investigative journalists to cover things with an extreme level of granularity so yes Paul Goldberg the chief editor of that outlet among the the reporter they covered this story with extreme granularity and in fact you know in some case some some industry advocates and some physicians really you know tried to accuse them of being biased you know it wasn’t that they were biased it was that they’re covering the story in an extreme level of detail and a very balanced way and I think anyone I would challenge anyone to read their writings and you’ll see that they they initially start covering this story in a balanced way and then when it becomes clear to them that there’s something seriously wrong here well they say there’s something seriously wrong here you know so yeah the consumer cancer letter covered the some other of very famous stories right yeah they think Paul took down annealed Poti Duke so they’re they’re serious reporters that’s for sure and you know I think their colleagues recognize that they and Martha Stewart okay yeah I didn’t know about that but you know the Matt um was awarded the National Press Club award for his work on the morsel a horse elation so I think good journalists are critical to any public health campaign so the three stilts of this thing where you know we were we knew what we were saying the FDA listened the press listened and I’ve heard you say that at some point good reporters with an ethical compass will invariably become activists what do you mean by that well look you know despite the fact that we live in a world where everyone’s opinion counts there are clearly at the at the boundaries there these places where they’re clear rights and wrongs and when a reporter starts reporting and reporting and reporting in fact after fact after fact lines up then they’ll states say state the fact and if and if there are people who are opponents of those facts right they don’t want to believe it they accuse them of bias right and so and so no it’s not it’s not bias it’s that a journalist at a certain point a good journalist at the end of the day is capable of putting the facts together and saying oh here’s it clear wrong right and so we’re gonna report it as such right you know but we do live in the in the world of alternate realities in fact so is that what you would say about the article that was published in the New England Journal of Medicine well so the New England Journal of Medicine just for background for those who don’t know published an article about my wife and I in a matter of campaign called n of one policymaking it’s a famous paper now it was published by dr. Lisa Rosenbaum was the Nedim you know correspondent the title of it was n of one policymaking and in that they you know as a predominant fact they essentially accused the FDA of n of one policymaking now you know I don’t know how the New England Journal of Medicine could call itself a self-respecting you know clinical journal and say that a 1 in 350 incidents of cancer upstaging and women represents n of 1 policymaking in there dr. Rosenbaum also felt comfortable calling my wife and I availability entrepreneurs which is code for charlatans so we fought that I mean we you know we argued against it we wrote a rebuttal and I think you know we sent some lawyers you know to knock on their doors and and then you did something else we wrote a rebuttal which the New England Journal of Medicine editors published and you complain about some HIPAA violation right well you know that was part of the larger story I think you know the details that are in the press and anyone interested to look at that yeah with all that was a fight for sure with all of this what have you succeeded to achieve well I mean look there’s some major milestones that we achieved as a result of all this to major actually a few major insurer insurance covered in insurance and insurance providers you know stopped paying for these operations UnitedHealth actually as a result of this campaign looked in their database at optimal optimal abs and they discovered that they are staring at this monster that for years they’ve been funding a procedure that’s risking that’s spreading cancers in women and so they stopped funding the procedure the reimbursements went down to zero from UnitedHealth which is how many million some of you in the audience were probably able to tell me how many million people are covered by you know Aetna followed suit you know so so I think the insurance industry’s response was was impressive and important the FDA did not ban the device which i think is a manifestation of the corruption at the FDA look the FDA’s job FDA is not a marketing agency FDA is a public health agency FDA is supposed to protect the only stakeholder of relevance to the FDA is the patient it should be the patient but what they have is this misconception that the stakeholders are somehow industry and and you know market marketeers and and and patients and and most the patients who show up at the FDA frankly are harmed so they’re frothing at the mouth they can’t even intelligently describe what went wrong to them with them so there’s this misconception that the FDA has multiple stakeholders the FDA stakeholders the only stakeholder at the FDA should be the patient so you everything about medical utility utilitarian is yes you know very hard for as the cost okay you did well this is the cause of this whole disaster what do you mean by that well look utilitarianism as a concept is a fantastic thing right benefit of the majority we want to do things that benefit the majority of the people right but the question is when you do things that benefit the majority the question always has to be what about the minority subset that don’t benefit and if they don’t benefit do they get harmed and is that harm avoidable right if you can’t ask those questions and if you can’t subject your utilitarianism to ethics then medical utilitarianism will become business will become a money-making business and with our healthcare system having a massive conduit into our insurance investments what happens with utilitarianism is our insurance investments will get sucked dry and with it the minority subsets of people here and there who fall to our service line mentalities you know will lose their shirt so what’s next well I think my challenge to this audience and to medicine X you know I mean this is Stanford and you know folks come up with new technologies you know I think that you know it’s nice to talk about diplomacy and collaboration and kindness and empathy all those are very very important ok but but you know look patients need an army you know I mean the reality is the vast majority doctors have beneficent intent right but the vast majority of doctors are also subservient to a system that’s becoming increasingly utilitarian the system the health care system needs feedback from the market the health care system needs feedback from individual patients ok the the labor unions of the 30s and 40s accomplished that the models are out there you know so I you know I think I think yes the challenge is to have empathy the challenges to have these beautiful shiny hospitals and and talk about how we’re going to create systems that are increasingly efficient and safe but unless the market provides feedback which is what our campaign was our campaign was one giant signal delivered to the healthcare establishment okay that needs to be codified patients need some sort of a for lack of a better term and you know jill has critiqued me on this the word Union is is something that’s synonymous with corruption these days right like labor unions are corrupt right but but you know that that at its inception labor unions actually you know defended and protected takes people’s lives and livelihoods you know I think patients need something like that not to become adversarial to the medical establishment you don’t want to be a you know it’s not that it’s not that you want to be adversarial to your doctor the doctor you know has been doesn’t intent but but when on the flip side you have utilitarianism driving these business models right where the purpose is to make money and the patients are essentially for the most part not the vast majority of patients aren’t doctors they can’t articulate what the problem is you know you put someone in that maze who’s gonna defend them who you know who speaks for the patient the assumption is that the doctor would but I think that’s an incorrect assumption and just because the folks sitting in this room think about it I mean what a minority subset of physicians are sitting in this room you know the vast majority of doctors okay don’t think in those terms especially in procedure oriented specialties I’ll be quite honest you know our specialties in surgery and then you know most procedure oriented you know specialties that works based on our views your paycheck your promotions have to do with how many procedures you do per month okay when you have that pressure on you medical ethics is going to come in second and so you know I think that the challenge to this audience is to to wonder and to ask can we actually create what the labor unions created for American workers for patients thank you our Tamizh [Applause] [Music]