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Published: Oct. 27, 2015, 7:52 p.m.

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Host \u2013 Dan Keller

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Hello, and welcome to Episode 58 of Multiple Sclerosis Discovery, the podcast of the MS Discovery Forum. I\u2019m your host, Dan Keller.

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A group of people are calling for a big change in improving care for people with MS. There may be no cure for MS yet, but there are a lot of ways to improve their outcomes. In this podcast, one of the ringleaders, Dr. Gavin Giovannoni, talks about a new push to use long-term brain health as a goal in MS treatment.

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The new report, called Brain Health, makes the point that time matters in MS. The authors draw on more than 300 research studies to show evidence that brain tissue can be preserved with early and effective treatment, and regular monitoring of disease activity. The report urges patients, physicians, health care payers, and policy makers to support the goal of life-long brain health.

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This podcast gives you the main take-home points from the Brain Health initiative, launched at the recent MS meeting in Barcelona, Spain. We will have extra podcasts for you in the coming weeks about other ways that evidence from research can be translated now into better MS outcomes.

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But first, here are some new items in the MS Discovery Forum.

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In the discussion section, a team of graduate students wants to hear from people with MS and their families. The team is from Santa Clara University, located in the heart of Silicon Valley in California. They have a class project to design a software product to assist people impacted by MS. Help them out by completing their survey.

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Coming up on our meetings and events list is next week\u2019s World Congress of Neurology in Santiago, Chile. MSDF will be there gathering new podcast interviews. If you, too, will be at the conference and would like to meet with us \u2013 or if you\u2019re interested in being interviewed about your research for a future podcast \u2013 please email us at editor@msdiscovery.org.

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The meeting list includes many specialty conferences and seminars of all the different kinds of scientific expertise that goes into understanding MS, from immunology to myelin biology, genetics, and brain and spinal cord imaging. Please add your meetings, workshops, and seminars. This is just one of the ways that MSDF shares information across the many different specialty areas to advance treatments for MS. Help us by adding other MS-research-related events. It\u2019s free to post.

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Our Drug-Development Pipeline contains 44 investigational and approved agents for MS. Last week, we added results from one new trial, we updated subject matter from four other trials, and we added eight other pieces of information to the database. One update summarizes findings gathered from a 15-year follow-up visit for participants in the PRISMS interferon beta-1a trial.

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And now to our interview with Dr. Gavin Giovannoni, head of neurology at Barts and The London School of Medicine and Dentistry in the U.K. We spoke with him at the recent European Committee for Treatment and Research in MS, or ECTRIMS, meeting in Barcelona about the Brain Health report that was launched at the meeting. The main thrust of the report \u2013 aimed at a broad audience of MS community members \u2013 is that time matters in MS.

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Interviewer \u2013 Dan Keller

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In terms of the Brain Health report, can you give me a broad overview of what the intent was and what you hope to accomplish?

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Interviewee \u2013 Gavin Giovannoni

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I mean, the real issue is to try to raise awareness and use it as a platform for trying to get policy changed. And the target audience is just the MS community, as well as health care providers, payers, politicians, etc. And one of the things we\u2019re beginning to realize now as we have more effective therapies, and we begin to learn more about MS, is that we are compromising the health of our patients by not treating them quickly enough or manage them quickly enough. I mean, there are large delays in patients being diagnosed, getting access to treatment, and when they\u2019re on treatment, they\u2019re not being monitored actively.

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And there\u2019s now emerging data that if you\u2019re on a therapy, and you\u2019ve got ongoing disease activity, you don\u2019t do very well in the long-term. So the idea is to try and encourage people to treat to a target, monitor, and escalate rapidly. So it\u2019s really trying not to waste time, too, essentially. And we borrow the term, \u201cTime is Brain\u201d from \u201cTime Matters\u201d from the stroke, where we know that, you know, every minute counts. And we would like to get the attitude across to people who are treating MS that every week, every month counts.

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MSDF

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At the initial diagnosis, how quickly should things move along, scanning, treatment?

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Dr. Giovannoni

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I mean, we\u2019ve got guidelines within our socialist healthcare system, the NHS, to get the diagnostic phase over with in a four-week period. If you\u2019ve got the disease, it\u2019s very anxiety-inducing, the whole process. In reality, you\u2019d like to get it over with in days. And then you need to start the counseling and education process. And I think you can\u2019t rush people onto therapy within days because the holistic approach is people got to understand their disease, the implications of the illness, the prognosis. They\u2019ve got to come to terms with it as well before you can actually start discussing the implications of therapy, which may be life-long. So I\u2019m not talking about this is like stroke \u2013 you have that thirteen minutes \u2013 I think you need to try and shorten the whole process and be active about it, not be passive.

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Most clinicians in the world now just monitor their patients clinically. They don\u2019t monitor them with MRI scans. They just wait for them to break through. Sometimes they accept minor relapses as just being part of the disease, and I think now that we\u2019ve got more effective therapies, we shouldn\u2019t be accepting any breakthrough activity. We should be escalating people to more effective therapies. And the data is becoming really strong that active disease, in the form of relapses or MRI activity, does portend a poor prognosis, so you want to switch it off.

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MSDF

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The report laid out some specific goals. Can you delineate some of those?

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Dr. Giovannoni

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The main goal is speeding up the whole process, so a rapid diagnosis, rapid initiation of treatment, monitoring, rapid escalation or possibly even flipping the pyramid \u2013 if they\u2019ve got a bad prognostic profile, give the more effective therapies. Also, collect data so by monitoring, you hopefully will change behavior. And then the other thing that\u2019s hidden is the cost effectiveness of these treatments. So, we need to make systems available to provide these drugs at cost effective prices, particularly in countries that are resource poor. It\u2019s fine talking about North America and Europe \u2013 relatively wealthy areas of the world \u2013 where we have insurance systems to pay for these expensive new emerging therapies. But if you just to any of the developing countries, people with the disease don\u2019t have access to disease-modifying treatments. We\u2019re just letting the disease run its natural course, and I find that very upsetting.

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There\u2019s a whole literature and emerging dataset on brain health from, mainly, the dementia \u2013 Alzheimer's field \u2013 and some of it\u2019s applicable to MS: getting patients to stop smoking; they must exercise regularly, try to avoid drugs that affect cognition, avoid excessive alcohol, sleep properly. Comorbidities must be managed actively. By that I mean hypertension, diabetes, etc. So there\u2019s all that lifestyle, comorbidity issues that also need to be focused on. It\u2019s basically making neurologists and healthcare professionals aware that there\u2019s more to the brain in MS than just inflammation. We need to think of it holistically and take it seriously.

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MSDF

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What do you see as some of the barriers to implementing all these things that you\u2019re recommending?

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Dr. Giovannoni

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The barriers I wish I could answer it easily. I mean, we know that there\u2019s slow adoption of innovation. Certain fields are more slow at adopting innovation than others, and I think neurologists, intrinsically, are quite conservative. And up until we had therapies in MS, we were just diagnosticians and giving prognoses. Now that we\u2019ve got treatments, we need to adapt to the fact that we\u2019ve got therapies that can make a difference to people with MS. So the slow adoption is attitude, culture, and regulatory hurdles. There\u2019s cost hurdles. Health insurance companies don\u2019t pay for our monitoring, in large parts of the world, so you\u2019re going to have to fight with them to be able to monitor with MRI scans. Patients themselves \u2013 try and nudge them to stop smoking and eat properly and exercise. It\u2019s easier said than done. I mean, this is a global population issue, and you know, why should people with MS be any different to the general population. So it\u2019s not easy. We need to think creatively about how we get this done.

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MSDF

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But it sounds like nihilism should be pass\xe9, if in the past, all you could do was diagnose and hope for the best. Now that\u2019s really not the situation.

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Dr. Giovannoni

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Yes, but I think there\u2019s another form of nihilism. And so in the past, we had therapeutic nihilism where we didn\u2019t give any therapies. I think we\u2019ve got a form of subliminal nihilism in the sense; we put people on less effective therapies. We\u2019re not monitoring them, but their disease remains active. I call it smoldering MS. Unless we monitor with sensitive MRI techniques, possibly other monitoring, we\u2019re not picking up the smoldering MS. And so I think we\u2019re potentially leaving a whole generation of people with smoldering MS to obviously a better outcome than they would have had with no therapy, but not as good an outcome if they would be as connected to more effective therapies.

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So that the subliminal nihilism, I just thought about that term, it kind of captures what I\u2019m trying to, because, you know, what we see affects behavior. If we don\u2019t see it, we don\u2019t change our behavior. So part of this report is to make people observe, measure, monitor. And if they see activity, hopefully, it\u2019ll change their behavior.

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MSDF

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In so many specialties, people say, well, I don\u2019t treat lab values. I don\u2019t treat images. I treat patients. But in this case, it seems like you do intervene when there is an imaging change.

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Dr. Giovannoni

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Yes, because we now have data, so this has got to be evidence-driven. And we\u2019re not saying every recommendation in the policy report\u2019s got unclad evidence about it. There is some weakness in the evidence base, but we think the evidence base is strong enough to make the recommendations. And we\u2019ve actually put into the report that where there isn\u2019t enough evidence, we need to generate more evidence. And to be honest with you, we need a population study comparing people managed with routine care versus patients treated to target with rapid escalation. MSBase has kind of done that without the MRI monitoring, because they don\u2019t have MRI data in their database. They\u2019re just looking at the clinical, letting people break through with relapses versus relapse-free, in those that are rendered activity-free clinically, do much, much better. And I think that tells us that if we were using MRI, it will even be better. So at least we know that MRI activity is a surrogate for relapses.

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And there\u2019s also scientific principle. We know, under the microscope, inflammatory lesions are not benign. They\u2019re associated with transected axons, neuronal loss, etc. So it\u2019s hard to deny the scientific principle of allowing lesions to continue to be active. To me it makes no biological sense. And this is not new. We\u2019re just stealing the ideas from rheumatology and nephrology. They treat to target. They try and suppress inflammation as much as possible, and they\u2019ve had incredible success. And they didn\u2019t do it from an evidence base; they did it from a scientific principle.

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And, as they collected their data in registries, they confirmed what the science showed. Long-term follow-up with these patients has shown that if you treat to target in rheumatoid arthritis and with rapid escalation, you protect joints. And joint replacements now in rheumatoid patients has plummeted by more than 80 percent.

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I think our metric will have to be walking sticks and wheelchairs. We\u2019ll see the use of walking sticks and wheelchairs plummet. Maybe employment \u2013 that\u2019s the other thing we\u2019re trying to highlight is most of the early disability in MS is not physical, it\u2019s cognitive. And the early unemployment rates that occur before people become physically disabled are driven by cognitive problems which manifest as cognitive fatigue. So, you know, what we\u2019re trying to do is also shift people\u2019s attention away from just physical disability and think about cognition, which is an early disability. And hopefully, if we can treat people as early as possible, we\u2019ll protect their cognition and allow them to continue working. So maybe the metric should be employment, as one of the metrics.

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MSDF

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So many reports in all areas come out and they\u2019re sort of one-shot deals. Do you have a plan for giving this thing legs so that it\u2019s not just buried once it came out?

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Dr. Giovannoni

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Yes, so we\u2019ve got a whole lot of initiatives following on this. We\u2019ve put together a grant application package. We\u2019ve got a dissemination plan, both at a regional and international level. We\u2019ll also want it connected to audit tools, so provide some audit tools where you can actually audit\u2014measure\u2014what we\u2019re trying to achieve and, hopefully, use that as a quality metric. We think we if can start measuring, people will change their behavior. We also want to create an audit tool for people with MS to audit their own service. So in other words, they will go in and say, am I being monitored? How am I being monitored, just clinically or with MRI? And ask the right questions, and, hopefully, activating patients to ask their clinicians to be monitored may also change behavior.

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We don\u2019t want it to be a name and shame type thing. We want it to be a positive thing, by measuring, we\u2019ll change behavior, so that\u2019s what we want to do. The only thing, though, it can\u2019t be done quickly. We need to get buy in from the whole community, so we\u2019ll have to have an engagement program to get there. Get a competition going, international competition where people can provide creative ideas to try and help with viral dissemination. So get an infographic or a movie or a play or a book or a poem, something that can go viral. And then we\u2019re going to, hopefully, have funding to update the report.

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We are going to have a very active website where people can download the report. And we\u2019re going to try and create content around Brain Health. Another thing we\u2019re going to be doing is looking for funding to translate it into other languages. We\u2019ve already had requests from several non-English speaking nations for translations. So the Dutch want it translated. South America wants it in Spanish. We\u2019ve had a request from the Japanese, Russians. And so if we can get it translated, we\u2019re probably not going to get the whole document translated. We\u2019re going to make executive summaries, one for patient focused, one for clinicians, one for policy makers. And we\u2019ll, hopefully, get those translated into multiple languages.

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MSDF

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MSDF will put the link on the site so that people can access it in English now. Is there anything to add or we\u2019ve missed?

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Dr. Giovannoni

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I think we\u2019ve got to start changing the behavior of neurologists in the sense that we need to make them think of their responsibility for looking after people with MS\u2019s brains. We tend to focus on making them relapse free. If we actually shifted the target away from being relapse free but maintaining brain health, so these people can age as normally as possible \u2013 we\u2019re not trying to say that people with MS will age normally, but we need our brains for when we get older. So if they start taking responsibility for the holistic management of MS, I think we\u2019ll get the momentum going where people will be much more actively managing MS.

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MSDF

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Thank you for listening to Episode 58 of Multiple Sclerosis Discovery. This podcast was produced by the MS Discovery Forum, MSDF, the premier source of independent news and information on MS research. MSDF\u2019s executive editor is Carol Cruzan Morton. Heather McDonald curated the MSDF drug database updates. Msdiscovery.org is part of the nonprofit Accelerated Cure Project for Multiple Sclerosis. Robert McBurney is our President and CEO, and Hollie Schmidt is Vice President of Scientific Operations.

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MSdiscovery.org aims to focus attention on what is known and not yet known about the causes of MS and related conditions, their pathological mechanisms, and potential ways to intervene. By communicating this information in a way that builds bridges among different disciplines, we hope to open new routes toward significant clinical advances.

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We\u2019re interested in your opinions. Please join the discussion on one of our online forums or send comments, criticisms, and suggestions to editor@msdiscovery.org.

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For Multiple Sclerosis Discovery, I'm Dan Keller.

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