GM: Kathy and Julio, thank you very much indeed all three of you for coming after a very long and quite tiring day but a very stimulating day to talk about take-home messages. We know that there is convergence of meaning of what personalised medicine is for the doctors working in multidisciplinary teams, we’re also completely clear that the patients are not being let into the secret yet. Tell us how that should happen.
KO: Yes, Gordon, I think you’re absolutely right. I think that patients hear the term personalised medicine and they really don’t know what it’s about. Many patients believe they’re already receiving personalised medicine in the way of a multidisciplinary team approach where they’re being treated, in the support that they get from their oncology nurses, and so I think we really do need to make clear to patients what this personalised medicine is all about. I personally feel that we should talk about targeted therapies, for example, I think they will understand that; we need to make them understand that it’s not just about drugs, it’s also about radiotherapy, about surgical approaches, it’s a whole shift in the way things are going to be done. I think it’s a very exciting shift but I was relieved today to come to this because we also talked about the challenges involved in so-called personalised medicine, targeted therapies, whatever. And there are significant challenges involved, it’s not just going to be the magic bullet we’ve all been looking for. There are substantial ethical, moral, all kinds of issues involved here and that’s what we talked about today and it was good to get them on the table.
GM: So you turned that into a policy advice for the ECCO Oncopolicy Group which would be educate the patients, involve the patients, empower the patients.
KO: Absolutely and come up with some definitions and then patients will understand. I think there is a fear among patients, to be honest, that they may not have the right profile for therapies and what happens to them if they don’t. It’s the haves and the have-nots, and I think patients need to be reassured about that and patients need to be told what’s going to happen to you if you don’t fit the molecular requirements of a particular trial or a therapy. So there’s a lot of work to be done.
GM: I think it was the ECCO President who said precision therapy, you like precision?
KO: I like precision.
GM: Rather than targeted or…? Because I think it’s quite…
KO: Yes, I think precision is great. Precision I like; stratified is a little bit harder to understand.
GM: I didn’t understand that either.
KO: But precision is good, I vote for that.
GM: So, Chairman of the Oncopolicy Committee, Julio, tell us what you’re going to take to the ECCO committee, starting with the opportunity, of course, of Horizon 2020 which members of the Commission talked about this morning.
JC: The main goal with the Oncopolicy Forum for this personalised medicine topic was to identify the issues that are related to personalised medicine, to engage all the stakeholders that have something to say or to do in this area and then for ECCO to drive policy on some of the priorities that would be selected. Obviously there are many priorities that will come but I think as ECCO we have to be able to do some of them and we need to work in collaboration with other organisations that we could share the responsibility because we are not experts in all of these areas. So the idea is to have priorities and then to find out what is the best way that we could do it in collaboration to make sure that all the priorities that are needed to be sure that we speed up the use of discoveries to forward the patient case is there. So it’s really very simple. The question, of course, is that there are economic implications of that and we need to deal with that. I think it’s important. Now, the main question, of course, is how can we have an influence on policy. How can we make sure that cancer remains at the top of the agenda for policy makers? Now, of course, we believe that Horizon 2020, which is the funding instrument for the community for the year 2014-2020, we do have the opportunity to have a say. We have been promoting the idea together with other biomedical societies the possibility of creating the European Council for Health Research which is strategic action for health. How can we get the cancer community, the scientists, to define the health research agenda in Europe? That of course has a lot of implications because our idea is to make sure that we not only set priorities in the areas that we need to work in the same biomedical research but we also have to have a say on how we’re going to deal with regulatory bodies, how we’re going to get the member states interested in doing cross-border collaboration. Because, as you heard this morning from their representative on the Commission, only 3% in cancer goes into the Commission, 97% remains the member states. So if we are going to get sustainability in our policy actions, unless we get the sustainability on our research initiatives we are not going to succeed. So it’s very important that this idea of this strategic action for health research could bring in the member states and other funders together to make sure that we have the possibility.
GM: I suppose ECCO might be thinking that way too, keeping it within the cancer area once more. There were one or two issues that came up as clear priorities that can’t wait for 2020, such as the ethical issues and the data protection issues, and we’re looking at the Data Protection Act at the moment. There is serious concern right across the floor about this piece of legislation killing translational research and personalised medicine for good because it is completely misguided and misdirected. I thought that patients were vociferous and united in condemning a piece of paper written by lawyers to protect the patients without the patients actually being asked whether they wanted protecting or not. Are you going to move on this one as President of ECCO?
CV: Well we are going to move on many sides on that, with this respect. We need a lot of co-ordination with all our member societies to really have one voice to Europe that this cannot happen and this will impair the developments and we need speed in the developments instead. On the contrary, we are working now also on harmonising databases and uniforming databases that we can learn from that. We heard some fascinating talks about pathways and specific drugs and targeted drugs, of course that is the precision medicine we need in the future but it applies only to a few patients unfortunately. So that needs also co-ordination throughout Europe that we have the availability of tissue banks that we have not only co-ordination with pathologists but also radiologists and also the clinicians view and the patients and share decision making of all this. So the amount of information coming in the coming ten years will be enormous and needs a lot of co-ordination that should not be sorted out by individual organisations, consortia. And also this threshold, of course, should be our first priority so that research can be moved forward fast.
GM: It will be very difficult to move tissue around between country and country, from biobank to biobank, even sets of gene signatures which might be traceable back to an individual person despite double anonymization if the Data Protection Act goes the way that it’s looking at the moment. So on the ethical side there were some interesting discussions but I don’t think any consensus about whether we have local ethical committees, regional ethical committees or guidelines for these committees, national or international. Where do you think the ethical issue is going to go? Is it really a handicap or not?
KO: Yes, I got the impression today, Gordon, that people were calling for a standardised ethical approach to this and I think people underestimate the determination that patients have in making a difference to research because of their experience of cancer personally. I think we shouldn’t put barriers up, people are being too, maybe, oversensitive. We need to protect the privacy of an individual to a great degree of course, but in terms of research we need to do everything we can to support the collection of tissue, biobanking, exchange of data, being able to send samples back and forth. And as patient groups I think we’re very well placed to put pressure on that area so that we can obtain a better result and not find that we have restrictive, overly restrictive regulations stopping progress. When you’re diagnosed with a cancer, and I lost my son to a brain tumour, my brother has been diagnosed with a chordoma now, I have numerous friends who have been diagnosed with cancer and one of the main things they want to do is help, do something that will make a difference as some reason for them having to go through this.
GM: And you’re in a hurry.
KO: We’re in a hurry.
GM: Yes, absolutely.
KO: We don’t have the time. We don’t have years to wait for trial results, research, very ponderous research programmes. We need information now, we really do. We need better treatments now.
GM: OK, you’ve heard it, no more ponderous research, Julio. But what we’ve already got, which is terribly exciting, all these next, next generations which are throwing us all this information which we simple doctors really can’t handle. We’ve had question marks about quality and a need for a policy to deal with the quality assurance of the various technologies across the various cancer centres in Europe. And those that are even already established there’s an error rate so that’s got to be sorted too and presumably this is something that you can leap straight into in your policy committee?
JC: I guess what we need is a change of culture, mainly because we are pushed as scientists to be individualistic because we have to compete, we have to get the new grants, we have to move into another position. So we need to get people to work together, teamwork, and we need to devise new ways to evaluate the impact of your work on life, not just on, on journals. So we need to work into that direction and I think the main problem that I see is that we are working with a disease that goes all the way from discovery, basic research, to care which is clinical work. Most of the problems that we tackle today are mostly due to the fact that health is not a competence of the European Union. So actually we are tackling this in small portions at a time where there are ethical issues, where other reimbursement issues. So in some ways I think we have to start looking at this in a different way. We have to get the health ministries to work with the research ministries and we have to get to work with research. Then perhaps we will have a context where perhaps we could really work in a much easier way. It is very hard, I think, for professionals to know where to knock the door when they have a problem and I think that we need to do something about that.
CV: Yes, there is since a number of years quite some collaboration and I come back to one of the things I’m passionate about and that’s EURECCA, European Registration of Cancer Care. As quality assurance, quality assurance going from certain HER2 testing which has shown to be 15% false positive and the other way around as well, so you get demanding, costly treatments for nothing and the other way around. But also looking at the whole team performance, how is this team performing, and auditing this so put it at a level further so that you look at the best performers, what do they do better than the others, but also, of course, controlling and giving feedback to the worst performers you can perform better. There have been examples so far that nationwide improvement in the care and outcome of certain diseases are enormous and all the team members are involved and we want to expand that further, also to the diagnostic disciplines but also to patients who report their experience with the different treatments so we can monitor that further. That’s where we want to have the cancer patient, central, as the whole team looking from research to outcome and cost efficiency as well.
GM: If you lose the patient’s trust then you’re in real trouble. You brought a point to the floor yourself that it’s not just a question of quality assurance in terms of delivery of clinical care and gene signature machinery etc., but also imaging. This is also a challenge.
CV: Yes, there are exciting new imaging possibilities, even in my own profession imaged-guided surgery is really an exciting thing. But those are also possibilities of controlling and seeing if there are early responses so that patients do not get a certain treatment in vain. But on the other hand also seeing that you cannot perform an operation safely which was firstly not possible because that was the reason to give neoadjuvant treatment. So imaging, diagnosis, pathway recognition, that should all come together and that should be implemented fast in certain countries because it will save lives or organs or quality of life.
GM: Purely by organisational improvement.
GM: Now, another area in the session I was involved in in terms of policy development was in HDAs and we saw this extraordinary improved record of the EMA in dealing with medicines but the getting the medicine from the EMA to the patients was a massive mess, I think it was described. I think there are 90 HDAs around Europe. This is something, as I remarked at the time, we do very well, we proliferate useless bodies very effectively. That seemed to me to be a very obvious policy issue that ECCO needs to get its teeth into.
CV: It needs co-ordination, the same with guidelines. Every country makes its own guidelines and I do not foresee that it will be European guidelines, in the ideal world perhaps yes, but there should be a platform of European guidelines supported by all the member societies of ECCO that can then be implemented on a national basis depending on infrastructure or aspects of the countries. So that’s also a matter of co-ordination and being in good contact and communication with all the member societies.
GM: You’ve put on a very good meeting, and your team, what’s your one take-home message that’s the most important for your branch of the business?
JC: Well, the most important, to me, is that everybody levels on the information that we have and they all understand that we cannot solve this problem unless we work together. If we achieve that and we agree on a single voice of items that cut across all our disciplines I think we do have a pretty good chance to make policy makers listen to our advice. At the end of the day researchers should actually be in a position to define the agenda for research. So it takes time but I think we have never done that before. We never actually have got all of the clinical and research communities together. Now we are together with cardiovascular, diabetes, respiratory because they are items that we share. There are many technologies that are the same, there are many biological processes that are shared between different diseases.
GM: I think that’s very interesting and there is also, to take the issue even further that this is not just a cancer problem but a cardiology problem…
JC: This is everybody.
GM: There’s now a European alliance of personalised medicine which was stimulated by the patients. Now, what’s your take-home message? You’ve been consulted, have you had your voice out? Have you had the influence that you had hoped for?
KO: Yes, I would hope we have. Julio mentioned collaboration and I think my take-home message would be we must collaborate, all of us together. This is a very complex area, we’re in very shifting times, things are changing quite a lot but we need to collaborate and that’s where patient groups can come in. We can feed back information of real world experiences, patient reported outcomes but we all need to work on this together, collaboration is key. In fact, that is the theme of our patient tract next year at ECCO in Amsterdam, collaboration.
GM: Good, Kathy, Julio, Mr President, thank you very much indeed.