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Episode 416: The Updated McDonald Diagnostic Criteria for MS with Dr. Andrew Solomon
00:27:52
Since 2001, clinicians have relied on the McDonald Diagnostic Criteria as the gold standard for diagnosing someone with multiple sclerosis. As science continues to add to our understanding of MS, the McDonald Criteria have been updated in 2005, 2010,...
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- [00:01]
A
I'm john strum, and this is real talk, mississippi.
- [00:18]
It's August 19th, and we have a lot to talk about. Since 2001, clinicians have relied on the McDonald diagnostic criteria as the gold standard for diagnosing someone with multiple sclerosis. As science continues to add to our understanding of MS, the McDonald criteria have been updated in 2005, 2010, 2017, and most recently in 2024. This latest iteration of the McDonald criteria will be published next month, and today Dr. Andrew Solomon is joining me to give us a preview of what these changes are, what they mean, and how they're going to improve the process of diagnosing someone with Ms. Dr. Solomon is a neurologist and chair of the Department of Neurological Sciences at the Larner College of Medicine at the University of Vermont. But before we get to my conversation with Dr. Solomon, there are a few other things that you should know about.
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By now, I'm sure most of you are well acquainted with the early signs of Ms. Maybe for you it was unexplained tingling in your arms or legs. Maybe it was an episode of optic neuritis, or maybe it was a loss of balance. But what if those well known symptoms weren't really early signs? What if the early signs of Ms. Had actually appeared many years earlier? Recently published research findings from Dr. Helen Tremlett and her team at the University of British Columbia indicate that Ms. May actually start 14 or 15 years earlier than has typically been assumed. But it may not start with what we've come to know as those typical symptoms. The prodromal phase of a disease occurs before the onset of typical signs and symptoms of the disease. In the case of ms, the prodrome occurs before an individual experiences any of the typical symptoms of Ms. And one of the ways that researchers have attempted to identify the Ms. Prodrome is by examining health care usage in the years before someone is diagnosed with Ms. And prior studies have shown that people with Ms. Have higher health care usage in the 10 to 15 years before being diagnosed. However, most of you also know that there is a difference, sometimes a many years long difference, between the time you experience the first symptoms of Ms. And the time you finally received a diagnosis. So in this study, Dr. Tremlett's team analyzed Ms. Clinic records in British Columbia, and they were able to identify 2038 people whose medical record included not only a date of diagnosis but a known date of Ms. Symptom onset. These 2038 people were each statistically matched with five people who didn't have MS, and they were matched Based on sex, birth year and the region of Canada they lived in. The researchers analyzed the medical records of these 2038 people with Ms. Up to 25 years before the date of Ms. Symptom onset and they compared those records to the control group of about 10,000 people who didn't have Ms. This analysis revealed that as early as 14 years before the onset of Ms. Symptoms, the rate of doctor's visits among the people with Ms. Was significantly and consistently higher, 19% higher compared to those people who didn't have Ms. And the year before Ms. Symptom onset, the rate of those doctor visits were 28% higher than they were among people who didn't have Ms. When the researchers drilled down and looked at the reasons for those doctors visits, they found that rates for ill defined signs and symptoms were 15% higher for 15 years before the onset of Ms. Symptoms and 47% higher the year before the onset of symptoms. The rate of mental health related doctor visits were among those that were higher the longest and were significant from 14 years before the onset of Ms. Symptoms, with rates of doctor visits for mental health related conditions increasing to between 30 and 38% higher. In the three years before Ms. Symptom onset. Doctor visits for sensory organ conditions were higher eight years prior to the onset of Ms. Symptoms, they were higher five years prior to the onset of Ms. Symptoms for muscle and skeleton related conditions and they were higher four years before the onset of Ms. Symptoms for nervous system related conditions. The year before the onset of Ms. Symptoms, doctor visits for sensory organ conditions were 51% higher than they were among the control group. Doctor visits for muscle and skeleton related conditions were 29% higher and visits for mental health related conditions were 14% higher. Two things make this study very important. First, imagine that someone without any physical symptoms sees their doctor for depression or fatigue and that visit prompts an MRI exam. That MRI scan is analyzed by an artificial intelligence app that's been trained to identify imaging patterns that escape human detection. And that AI app indicates that this person without a single physical symptom has Ms. Could intervention with a high efficacy disease modifying therapy mean that this person might never experience a single physical Ms. Symptom? This isn't science fiction. The pieces necessary to complete this puzzle are quickly falling into place, and this study is an important part of making this scenario a reality. Let's also look at the bigger picture here. It's hard to identify the cause of a disease without knowing when it actually begins in a person. If researchers stay focused on that date of diagnosis or even the first date of symptom onset and fail to see these non specific signs and symptoms that actually begin years earlier, they can end up attaching importance to the wrong things that are happening at the wrong time and that won't get us where we need to go. If we're going to uncover the cause or causes of ms, we need to start at the actual beginning, which, based on the evidence in this study, occurs 14 or 15 years before the onset of the first physical symptoms of Ms. If you'd like to review the details of this important study, you'll find a link in today's show notes. And if you'd like to review a plain English report on this study from our friend Sharon Roman, you'll also find a link to her plain English explanation in today's show Notes.
- [07:41]
Results of a study from a research team in Italy show that the number of people with relapsing remitting Ms. Who transition to secondary progressive Ms. Is declining. This study focused on characterizing the Ms. Disease course from onset to secondary progressive Ms. By examining the records of 9,958 people with Ms. In the Italian Ms. Registry and through some fairly complex statistical calculations, the researchers were able to demonstrate that over time there was about a 10% reduction in the number of people who transitioned to secondary progressive Ms. Between 1993 and 2018. Among the people who did transition to secondary progressive MS, that transition occurred after an average of eight and a half years. The average age of the people who transitioned to secondary Progressive Ms. Was 36.6 years old and they had a higher average EDSS score compared to the people with Ms. Who did not transition to secondary progressive Ms. As a quick refresher, EDSS stands for the Expanded Disability Status Scale that neurologists use to characterize an individual's level of disability. The people who transitioned to secondary progressive Ms. Had a higher rate of no DMT user and lower overall Ms. Treatment compared to the people who didn't transition to secondary progressive ms, which serves as one more reminder of how important it is to start a disease modifying therapy and then stay on a disease modifying therapy. The improvement in the overall decline in secondary progressive Ms. Diagnoses were attributed to the fact that today's disease modifying therapies are effective at delaying progression, along with additional factors like shifts in how Ms. Is diagnosed, more specific definitions of disease progression and evolving clinical practices. Now, if you'd like to review the details of this study, you'll find a link in today's show notes.
- [09:51]
Your voice and your opinion matter and including the Patient Voice in the FDA's regulatory review process for new medications is an important aspect of the 21st Century Cures act, which was passed by Congress and signed into law by President Obama in 2016. The overall aim of this law is to accelerate discovery, development and delivery of new medical treatments and mandating patient focused drug development. Meetings with the FDA is the part of the law that formally requires that patient experiences and perspectives are integrated into the drug development and regulation regulatory review process. The National Ms. Society is leading the Shaping Tomorrow Together initiative that culminates in an interactive patient focused drug development meeting with the FDA that will be held in person, by invitation in College Park, Maryland and also streamed live on zoom. This meeting will ultimately lead to the publication of a Voice of the patient report in 2026, but I'm getting a little ahead of myself here because the process begins by having as many people affected by Ms. As possible share their experiences by taking the Shaping Tomorrow Together survey. This is an online survey that should take you about 45 minutes to complete. You don't have to do it all at once, you can come back to it and your work will have been saved. And once you have completed the survey, you can enter to win one of ten $50Amazon gift cards. And I'll add that by completing this survey, you'll be adding your voice and your experiences as someone affected by Ms. To all the other information the FDA will ultimately receive. You'll find a link to the survey in today's Show Notes and I'm inviting each of you to click on that link, complete the survey and help the FDA better understand the things that are most important to people who are affected by Ms. Once you've completed the survey, you should register to join the National Ms. Society on October 29th when the Ms. Society will live stream the Shaping Tomorrow Together meeting. This meeting will be an opportunity for the Ms. Community to share their lived experiences with the FDA staff in charge of regulating drugs, with people working at life science companies, with healthcare professionals, and with Ms. Researchers. During the meeting, the Ms. Society will share the initial survey results and dive deeper into what it means to live with ms, including hearing from you about the daily impacts of ms, how you manage and treat your ms, and what matters most to you about current and new therapies. This is truly a once in a lifetime chance for the Ms. Community to come together to make a difference in future Ms. Treatments. I hope you'll complete the survey and then register to join the National Ms. Society live from your home OR office on October 29th. You'll find both the survey and the zoom registration links in today's show. Notes.
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For all my friends and listeners in Canada, I want to remind you that A W's Burgers to Beat Ms. Day takes place in just two days of on August 21st at A& W locations across Canada. For those of you living in Canada or those of you with plans to be in Canada on Thursday, A and W will donate $2 for every team burger sold to support Canadians affected by Ms. Canada has the highest per capita rate of Ms. In the world. Every two hours of every day someone in Canada is told you have Ms. Since 2008, A&W has raised over $20 million to support research, programs and services for Canadians living with Ms. And if you'd like to participate but you don't want to wait until Thursday or you don't happen to live in Canada, you can visit burgerstobeatms CA and make your online donation today and you'll find that link in today's show. Notes.
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The updated McDonald criteria for diagnosing Ms. Won't beat MS, but getting a timely, accurate diagnosis will put someone in the best position to start on a disease modifying therapy that will delay Ms. Progression and preserve a better quality of life. In a moment, we'll be joined by my guest, Dr. Andrew Solomon, who's here to give us a preview of what the updated McDonald criteria for diagnosing Ms. Are all about.
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Since 2001, clinicians have relied on the McDonald diagnostic criteria as the gold standard for diagnosing someone with multiple sclerosis. As science continues to add to our understanding of MS, the McDonald criteria has been updated in 2005, 2010, 2017 and most recently in 2024. Dr. Andrew Solomon, a neurologist and chair of the Department of Neurological Sciences at the Larner College of Medicine at the University of Vermont, returns to the podcast this time to discuss what the latest update to the McDonald criteria is all about and how it will affect the process of diagnosing someone with Ms. Welcome back to the podcast, Dr. Solomon.
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B
Hi John, thanks for having me. It's great to be back.
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A
I'm hoping you'll start us off by explaining why Ms. Needs diagnostic criteria.
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B
This is a great question.
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There are some diseases where we have a very good test and if somebody gets this blood test we can say yes, you have this disease. But there are many diseases in medicine and neurology and other fields where we rely on a variety of assessments, like a recipe, where we look at the neurologic examination, other testing like MRI and spinal Fluid testing and so on, to come to a diagnosis. And what that recipe involves is based on a lot of research that helps us get to the diagnostic criteria. But ultimately, what the purpose of a diagnostic criteria is, so that when doctors give a diagnosis like ms, that we're all talking about the same thing, and that such that when we're testing new treatments for ms, patients who are in those studies all have the same thing. And we know that with some confidence that it'll work. If it shows that it works, it'll work in our patients who also meet that criteria. So it's very important to sort of stay on the same page. We all agree that Ms. Is an autoimmune disease, and we have a lot of data that's accumulated over half a century that gives us a lot of confidence that it's one disorder that can be a little bit challenging to diagnose because it can present in many ways.
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A
So what's been added or changed in this latest update to the McDonald criteria.
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B
This is a really big change. This criteria makes a lot more changes than previous criteria. I think globally or.
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From an overview standpoint, there's more pathways to the diagnosis of Ms. For patients that will allow them to be diagnosed earlier, which is great. And we know this will improve outcomes because we would start treatment earlier in such patients. There's also some different, maybe we could call them guardrails built in that prevent misdiagnosis, that improve diagnostic accuracy, so prevent patients from being given the diagnosis of Ms. Who don't have Ms. I think those are the two biggest changes I do want to emphasize. You know, when we talk about these different pathways, we're incorporating new types of testing that may allow us to diagnose Ms. Earlier. And we're also looking at findings that we had looked at before on MRI that also. We've changed the criteria for that also allow some patients to be diagnosed earlier.
- [18:14]
A
And again, the benefit to that early diagnosis is. Is earlier intervention leads to better outcomes, right?
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B
Exactly. We have some data that we've been diagnosing patients earlier in tandem with each of these revisions to Ms. Diagnostic criteria over the years. So we've been able to move the diagnosis earlier and treat patients earlier as a result, and patients are doing better in tandem with each revision to the criteria.
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A
Well, what is the actual process for updating the criteria and who is involved?
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B
It's a quite lengthy process. It begins years ahead of time. There's a committee that's sponsored by the National Ms. Society in the United States and the European Committee for Treatment and research and Ms. In Europe that has members spread across many countries around the world with different expertise in Ms. And pertaining to the diagnosis of Ms. The process involves initially meetings to decide whether or not there's enough new data or research that we should revise the criteria. And through those meetings there was a decision that we should. And then as all that data was presented, questions about changes to the criteria were formulated and an in person meeting was held among over 50 participants from this committee as well as other experts that were brought in. Patient advocacy organizations, patients themselves were involved. And there were these statements, voting statements that were made with a thrill threshold that was required and predetermined ahead of time for incorporating a new element into the criteria. And there was discussion and then this big group voted on whether changes should be made. And then the process after that was creating the actual document, the diagnostic criteria and finessing that with all of these authors. And this year for the first time, there are a number of companion papers that will come out at the same time as the publication that aim to really help inform how the criteria are used, especially with some of the new changes in imaging or CSF evaluation or assessment of the optic nerve. These are, these are new changes in the criteria and there's entire papers devoted to teaching providers how to, how to implement these changes.
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A
For some people, getting an Ms. Diagnosis turns into a bit of an ordeal, requiring multiple tests and retests that can stretch out over months and years, even years before they actually receive a diagnosis. Will the updated McDonald criteria improve this process?
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B
That's a great question. No one, nobody's, we tell patients, you know, your Ms. Is your Ms. And every, every presentation can be quite different and it's a quite, we say, heterogeneous or varied disease that can, can really strike in different ways. So, but I, but, so, you know, it's hard to say something universal but, but I do think because there's multiple new ways to confirm the diagnosis in some instances with just a single mri, with fewer tests, that some patients will receive a diagnosis earlier and without so much monitoring and testing, I think that there's a high likelihood of that. Can we prevent some testing and everybody. Probably not. And in some cases it's really helpful. So there are new types of tests that are incorporated in the new criteria, new imaging techniques, new ways to test spinal fluid and new ways to evaluate the optic nerve that.
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Would actually expedite diagnosis of Ms. So in some instances, more testing might result in an earlier diagnosis. In the end, that's what we want.
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A
Could the updated Criteria somehow reverse someone's Ms. Diagnosis.
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B
Great question. No, that's the answer. So it's certainly a reasonable worry. You have a diagnosis and now there's a new weighted new diagnostic criteria. Is my diagnosis still the same and valid? But no. Anybody who received a diagnosis of Ms. By priority diagnostic criteria, any of them would still fulfill our current diagnostic criteria.
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A
Well, let's talk about those folks who may have been previously diagnosed. Did the new criteria have anything to do with their ongoing treatment or care?
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B
That's a great question. No. You know, so the criteria are really focused on making early and accurate diagnosis and patients undergoing evaluation for Ms. Once that diagnosis is made. The criteria really don't have anything to do with treatment recommendations or treatment guidelines. That's outside the scope of this effort.
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A
How will the updated criteria be communicated to healthcare providers?
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B
This is always a struggle because, you know, simply publishing a paper is inadequate. Right. To reach everybody. The effort has begun over the last year. So there's a lot of educational sessions at meetings that subspecialty neurologists, Ms. Specialists, as well as non specialists frequently attend. There's publications that are planned to sort of describe the criteria and how it works in an accessible way to non specialists. There's a lot of efforts to engage industry and all sorts of advocacy partners in the Ms. Care world to really get the word out. But it's going to require a fair amount of educational outreach to make providers aware of these changes and comfortable using them. And some of these tools are incredibly helpful that have been incorporated in the criteria, but do require a little bit of training on the part of providers who want to use them. So it's a big change, but there's a lot of effort behind it implementing the new criteria.
- [24:26]
A
When do you think people can expect their healthcare provider to begin using the updated criteria?
- [24:32]
B
Well, theoretically, they could use it as soon as it's published, and we're expecting this in September 2025, and it should be widely available. And increasingly, there are many in the field who are comfortable using the criteria, including its current revisions. So I think that if patients have a provider where they feel there are some barriers to implementing the criteria or they're not as familiar with it, I think, you know, advocating for them to discuss the criteria with an Ms. Specialist or perhaps a referral to Ms. Specialist could be a way to get an evaluation using the current criteria for somebody who's undergoing Ms. Evaluation where diagnosis is still uncertain.
- [25:20]
A
So let's fast Forward to October, November, December 2025. Is it appropriate for a patient to ask whether that healthcare provider is using the updated McDonald criteria.
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B
Absolutely. Absolutely. You know, I think even before that, I think every provider is obligated to explain to patients why they do or do not think they have a particular diagnosis. Right. And patients should.
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Feel that they have the ability to ask those kind of questions and whether or not the 2024 criteria was part of their thinking and where they wound up with their diagnosis.
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A
Dr. Andrew Solomon, I want to thank you for all you do to improve the lives of people who are living with Ms. Thanks so much for talking with me today.
- [26:12]
B
Thanks so much for having me.
- [26:14]
A
That's going to wrap up this episode of Real Talk Ms. RealTalk Ms. Is powered by the National Ms. Society and you can share this episode of the podcast by letting your friends or family members know that all they have to do is point their web browser@realtalkms.com 416. You'll find that link in today's show notes so you can easily copy and paste it right into an email or a text. You know, when it comes to managing ms, your most powerful tool isn't a pill. It's not an injection, not even an infusion. When it comes to managing ms, your mindset is one of the most powerful tools you have. And a growth mindset can make all the difference in how you experience your Ms. Journey. Next week on Real Talk. Ms. We'll be talking with Dr. Miriam Franco about how to go about cultivating a growth mindset when you're living with Ms. I hope you'll join me for that conversation. I'm John Strum. Thanks for listening. Stay safe and make healthy choices.
- [27:42]
C
Sam.