 It's a real pleasure for me to give the final talk of this session and I know some of you are worried that I might be singing, but I would never want to follow David and it would be unethical for me to sing so I won't do that. When Mark asked me a number of months ago to give him a title for this talk I said sure surgical informed consent I'll talk about that but in fact I'm going to talk about surgery on the cancer pre-vibr and changing the dynamic of surgical consent and I'll try to this is some thoughts that I don't have a lot of data on but I have a lot of fat thoughts about it and so I'm interested in other people's perceptions I have a disclosure but it's irrelevant to this presentation. So by way of outline I want to talk a little bit about what the cancer pre-vibr is and what prophylactic surgery is I want to talk about informed consent for surgery and then how we might need to change the way we talk about informed consent for prophylactic surgery compared to regular old operations. So what's the goal for cancer surgery if you think about it it is to remove the cancer and so in contrast to people like Juliano Testa who does transplants or Gretchen who does vascular surgery they fix things I don't ever fix anything I only take it out I have a very limited repertoire and so my kids no longer ask me about medical issues. So when we have a cancer patient and they the goal for surgery is to remove the cancer hopefully cure the patient do it with the lowest risk and so let me ask you to consider a case so a 30-year-old woman who's diagnosed with papillary thyroid cancer she consults with me I recommend surgery in this case she needs a total thyroidectomy the risks are low the benefits are high we can talk about that it's unlikely it's going to affect her long-term outcome in terms of quality of life and the patient wants the cancer out and that's what I can offer her and so we plan surgery and that's generally sort of how it goes when patients need surgery and even if there's a complication most patients say but you were treating cancer and in fact if the patient has a potentially high-risk operation but it's to remove a cancer many patients are willing to accept that because it is so good to get the cancer out or at least that's the perception so we heard a little bit of yesterday from Jonathan Marin a great talk about precision medicine and genetic testing and I want to just ask us to look at that in a slightly different way so the goal I would say a precision medicine and genetic testing is to predict in many ways who will get cancer and treat them before they ever get that cancer and so those people who have a genetic predisposition for cancer are known as cancer pre-vibers and so the question then is is pro-phylactic surgery on cancer pre-vibers any different from other operations now what's a cancer pre-viver well this is someone who has a predisposition to cancer but has not had the disease and so it derived from initially BRCA1 carriers who were at high risk for breast cancer and the thought was you couldn't really call them cancer survivors if they never had cancer and for those who have had cancer it was somewhat offending to consider this group of people who never got had cancer as part of that group and so it was an effort to create a different label and that's where pre-vibers came from so in the BRCA1 group many of these patients had pro-phylactic mastectomies so they might never get breast cancer and in fact over recent years we've had increasingly numbers of hereditary cancer syndromes we know about BRCA and breast cancer linse syndrome, cowden syndrome, I won't go into all of these leaf romani syndrome, CDH1 mutations that increase the risk for breast cancer, multiple endocrine aplasia type 2 now that's one that I really want to spend a lot of time talking about because as an endocrine surgeon you know that's what it's all about preventing medullary thyroid cancer I would argue that this is just the tip of the iceberg and that in future years there will be even more syndromes defined such that we can identify who will have a high likelihood of getting a cancer in the future so the ultimate treatment for the cancer pre-viver is pro-phylactic surgery and that is to remove the potentially diseased organ before the patient ever gets cancer so in MEN multiple endocrine aplasia types 2a and 2b carriers so these are people who can be identified based on genetic testing and these patients if they have the gene mutation they have a virtually 100% chance of developing medullary thyroid cancer in their lifetime and so this is a group of patients where if we make a diagnosis early and we take out their thyroid they won't ever get medullary thyroid cancer and so pro-phylactic total thyroidectomy prior to the development of medullary thyroid cancer means that patients are cured of a disease that they will never get so that's really the holy grail of all of precision medicine as far as I can tell so to prevent a cancer by removing an organ that will ultimately likely get cancer and frequently these patients are operated on in childhood and depending on the mutation sometimes in the first year of life even so there are I believe ethical issues in surgery on the pre-viver and so all surgery on pre-vivors is by definition pro-phylactic so it is to prevent the development of cancer it is not therapeutic so they don't yet have cancer so we're not treating a cancer but we're trying to prevent the development of a cancer so the question that I believe is important for us to address is are there differences in operating on a patient with cancer when compared to operating on a patient who has a risk of cancer and I would ask that you spend a couple minutes with me thinking about informed consent for pro-phylactic surgery so we all know about surgical informed consent we've heard some great talks about it much more thoughtful than mine we know that patients in order to give informed consent have to have the capacity to make a decision they need to understand something about the risk of the operation the benefits of the operation if there are alternatives they need to hear about the alternatives to the proposed surgery and I would argue that most surgeons that I talked to in the US really focus on risks when they're obtaining informed consent and even you know it's true that we have to explain why the surgery is recommended and I think as Gretchen pointed out the indication for surgery sort of what is going to be the benefit for surgery for the patient is important but risks are thought by many surgeons to be the patient's primary concern and that's what I see most preoperative information brochures that's what it really focuses on is the are the risks of surgery and I think many surgeons believe that by focusing on these risks we will actually reduce the likelihood for malpractice lawsuits if a complication occurs now whether that's true or not remains to be seen but I and that's not what I'm going to talk about but let me ask is there a difference when performing prophylactic surgery versus cancer surgery so from the surgeon's point of view I would suggest to you that it feels like a very different situation and I do believe that in prophylactic surgery there has to be a much greater emphasis on the benefits of the operation rather than just focusing on the risks of the surgery and it's really that risk-benefit ratio that becomes most important so I want you to consider two cases so case one five-year-old girl she has medullary thyroid cancer she's been diagnosed with it she has a total thyroidectomy in a central node dissection trust me it's appropriate surgery for this disease and she suffers a permanent recurrent laryngeal nerve injury causing permanent hoarseness so this is an unfortunate complication we know that this happens in thyroid surgery somewhere in the range of one to three percent of the time most surgeons say one percent many databases suggest it's a little higher but nevertheless it's not a common thing but it can happen even in the best hands consider a second case five-year-old girl has any end to a she has a genetic predisposition to medullary thyroid cancer she has a prophylactic total thyroidectomy and she suffers a permanent recurrent laryngeal nerve injury causing permanent hoarseness so think about the differences between these two cases so no one especially a surgeon wants a complication but I would argue that it's much easier for both surgeons and patients and their families to accept a complication when it occurs in the course of treating a cancer than in the course of treating what might become a cancer someday in the future and with the second case I would argue that many parents will always secretly wonder will our daughter ever have really gotten cancer we know what the genetic test shows we know what the statistics say but with probabilities it's not exactly a hundred percent of people that will get medullary thyroid cancer and so again I think that we need to start thinking about how to conceptualize informed consent in this patient population differently because in the future I think surgeons are going to be doing many many more of these operations so although the risks of surgery in these two groups may be completely unchanged so prophylactic surgery the risks of the thyroidectomy were the same as for the therapeutic thyroidectomy but the benefits are different if it is not to treat a known cancer so the question then is do the benefits of avoiding cancer outweigh the risks and there in that situation it really depends on how high is the chance of getting cancer and so it really shifts the focus of the conversation I think a little bit away from the actual risks of the cancer and so graphically because you know it's nice to have a graphic representation I'm not sure if this is a particularly good one or not but if you see when when it comes to cancer surgery I don't know if this I don't really have something that points but anyway on the on the left hand side here for cancer surgery if you look at benefits in blue and risks in the risk of getting an operation in red there's a large difference if you look at the risk of cancer well there's a tremendous if you already know you have cancer then that's clear if you look at a pre-viver surgery in the middle if the risk of getting cancer is low then the benefit is relatively low so even if the risks are exactly the same in those last two columns it's going to be much more likely that a patient is going to want the operation that's prophylactic when the risk of cancer is very high so so I think that we are going to have to shift our conversation to make this work so I do think that there are a lot of future issues that we're going to have to address are the complications of cancer pre-vivors more difficult to live with than the complications from treatment of cancer from a patient's perspective if you have the same disability is it more problematic if you know that you didn't actually have cancer our stresses on parents who choose surgery for their children who are cancer pre-vivors significantly different from stresses on parents of thyroid cancer survivors are there levels of cancer risk below which surgeons will be unwilling to offer prophylactic surgery because the benefits are too low and should it be the patient or the surgeon who decides what that benefit difference is that's great enough to warrant having the risks of the surgery so these are again more questions than answers which I think is okay in an ethics talk I do think that genetic testing for cancers will increase the number of cancers cancer pre-vivors in the years to come I do think that there are a lot of unanswered questions that remain regarding the long-term outcomes of cancer pre-vivors because this is a patient group that has really not been well identified or studied and I do think that as the genetic causes of cancer increase in the years to come there will be more and more patients who have this potential for prophylactic surgery and I do think that surgeons may need to change their approach to informed consent and focus much more on what the benefits are relative to the risks so with that I'm very happy to have had the chance to share these thoughts and I'm happy to answer any questions thank you very much yes no I absolutely agree and I think that you know it's it's a little it's a little bit hard to fault a surgeon for not wanting to take out an organ that is healthy based on a statistical probability that it may become diseased in the future so but yeah yeah hi Peter thank you so much I enjoyed that and as I mentioned I do breast cancer surgery so the pre-vivor thing is definitely with you and I think maybe if you had a third category when you gave your five year old young girls with cancer or risk of cancer because so much of this from my experience has to do with feelings and and how do you feel and how do your patients feel and how do they feel about these risks and if you have another group there where you say this five year old girl had a sister who died because they didn't get that test and now she has that test they're much more feeling like I need to do this and this is much more serious and my benefit is much greater so the closer the family member and the more family members who have died or had serious complications from chemotherapy or the actual cancer the more likely they are to see the benefit of saying I will take more risks and the benefit is large to me because it's very personal no excellent point and and you know I think that part of the part of the challenge is I mean I think in in medullary thyroid cancer when there's a virtually one hundred percent chance of getting cancer I feel like it is in some ways my role to try to convince the family that it is the right thing to have an operation but I do think that there are situations where the risk of cancer is not that high and deciding exactly whether my role should be one of encouraging strongly to have surgery or whether my role should be more one of sort of educator and you know leave it to the to the family to make a decision but yeah thanks for your comment there yeah just thinking out loud a little bit here but I think there could be a lot of parallels drawn between this idea and the world of living donor transplantation it's another group of patients who are well at the time surgery in a lot of ways and are you know making a donation for a loved one or a friend or something like that so I just I wonder if there are similarities in the consent process and I haven't been part of the consent process for living donor transplantation but be interesting to think about yeah no thank you excellent point all right thank you all very much