IBD Breakthroughs: Why No One Should Accept a ‘New Normal

In this powerful episode of Life Without Leaks, we welcome world-renowned IBD expert Dr. Marla Dubinsky of Mount Sinai to discuss the rapidly evolving landscape of Crohn’s disease and ulcerative colitis treatment. 

Dr. Dubinsky shares why early diagnosis and timely use of advanced therapies can dramatically change a patient’s long-term trajectory — and why too many people are still suffering unnecessarily. From delayed diagnoses and safety misconceptions to the stigma around bowel urgency and incontinence, this conversation tackles the real barriers patients face.

You’ll hear why symptom severity today doesn’t always predict future risk, why “mild” disease can still require serious treatment, and how modern therapies are reshaping outcomes. Most importantly, Dr. Dubinsky makes a compelling case that patients do not have to accept a life defined by flares, fear or leaks.

If you or someone you love is navigating IBD — or wondering when to seek care — this episode offers clarity, hope and actionable insight.

For more information about the National Association for Continence, click here, and be sure to follow us on Facebook, Instagram and Pinterest.

Music:
Rainbows Kevin MacLeod (incompetech.com)
Licensed under Creative Commons: By Attribution 3.0 License
http://creativecommons.org/licenses/by/3.0/

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Transcript

The following transcript was generated electronically. Please let us know if you see any transcribing errors and we'll get them corrected immediately. 

Bruce Kassover: Welcome to Life Without Leaks, a podcast by the National Association for Continence. NAFC is America's leading advocate for people with bladder and bowel conditions, with resources, connections to doctors, and a welcoming community of patients, physicians, and caregivers. All available at nafc.org. 

Welcome back to another episode of Life Without Leaks. I'm your host, Bruce Kassover, and joining us today is Sarah Jenkins, the Executive Director for the National Association for Continence. Welcome, Sarah.

Sarah Jenkins: Thanks Bruce.

Bruce Kassover: Yeah, we're excited because today we are welcoming Dr. Marla Dubinski to our podcast. She is a world-renowned expert in inflammatory bowel disease and a professor of pediatrics and medicine at the Icahn School of Medicine at Mount Sinai in New York. She's given More than two decades of her career to advancing personalized medicine in IBD.

She helps predict disease progression, improve outcomes, and does all sorts of innovative research and really delivers patient-centered care. So we're really interested in hearing what she has to share with us today. So thank you for joining us, Dr. Dubinski. 

Dr. Dubinsky: Thank you so much for asking me to be here. I'm really excited to talk more about how IBD impacts people's lives and how we can do better. 

Bruce Kassover: Yeah, that's, that's really something that, that we've been doing a lot of focusing on lately, but there's never enough because it's, you know, one of those conditions that I don't think people understand deeply enough or are comfortable talking about.

But before we even get there, I mean, you really are a distinguished practitioner, researcher, educator, physician. Maybe you could give us a little bit of your background, how you got to be on the podcast today and where you are professionally. 

Dr. Dubinsky: Sure I am I work here at Mount Sinai in New York. I am the co-director of the Susan and Leonard Feinstein IBD Center. 

such a important place, I think just because Crohn's was actually discovered here at Mount Sinai in 1932. So there's a really long legacy of innovation and research here at Sinai. But particularly for me, I have really dedicated my career to thinking about the patient from childhood all the way to adulthood. So I've got a very unique practice in that I trained originally in pediatric, GI and pediatric IBD and I am the chief here at Mount Sinai as well of that. But really have dedicated going on three decades now to optimizing and changing the lives of people with inflammatory bowel disease, children all the way to motherhood actually. So I have a really keen interest in women's reproductive health, fertility, pregnancy, postpartum, just because it's such an important time in an IBD patient's life, and there's not a lot of work or research that has been focused on that. And so really I've dedicated the last part of probably almost two decades now, focusing on improving the lives of women with inflammatory bowel disease as well. So I've been very lucky to be able to address really key special populations and look at patients as the human beings and sort of think outside of just transacting sort of, I think you need this therapy. And then sort of walking out of the room and leaving others to explain why certain therapies are so important and how we're in an era now where I believe people don't have to accept a new normal.

And my sort of lens through which I focus my care and the way I approach patients is, we could do better and, and empowering people with information and education on how to live their best life and elevate their overall resilience and quality of life. 

Bruce Kassover: Well, that's really interesting. It sounds like you are really on the cutting edge of a lot of the advances that we're seeing and, you know, if I am to believe my television from the commercials that I see, there are a lot of advances going on with regard to IBD and other sorts of digestive disorders. I mean, how is the state of knowledge advancing and, and where are we today compared to maybe, you know, 5, 10, 20 years ago? 

Dr. Dubinsky: Yeah. Even almost 30. I mean, Bruce, I, just to give my age away a little bit, I guess I trained as a fellow without advanced therapies. There was no biologic when I did my training, my general GI training. But when I entered my advanced fellowship in inflammatory bowel disease and did three extra years of training specifically, it was infliximab the first advanced therapy biologic strategy; that really was the first revolution of where we were, where we're taking what we were using steroids, immune suppressants...

There was a lot of fear around this idea that we went away from this traditional conventional therapy of steroids, which to be fair, steroids are the least safest drugs we have, but unfortunately are sometimes necessary in a more short term, acute, getting the fire out of the inflammation of the inside, for example, and deciding on an exit strategy with these advanced therapies.

But imagine we have a graph up at our meetings where we're giving talks and we go all the way back to 1998 and show the first introduction of biologics, and between 1998 and 2014, all we had was one target, right? We were all targeting very important inflammatory pathway, which is tumor necrosis factor, which is what infliximab and adalimumab and certolizumab and golimumab... we had a whole bunch, and then in 2014 we got what was deemed as a more gut-targeted, more gut-specific biologic strategy where we went from giving a drug that has sort of joint-skin-eyes-gut effect, which is amazing 'cause a lot of our patients have inflammation in multiple different parts of their body, but the idea that we were even going to get more targeted to the gut with the introduction of vedolizumab. And then the world really changed. I mean, from 2016 until now, so a decade, we have had multiple new classes. We've had the first pills that were approved, like actually approved and tested in a, in a phase three program, approved to deliver these advanced therapies.

And in the last year or two, we've had an explosion. That's the commercials you see, Bruce. So everything you see on TV, you would think everybody has some form of immune condition, 'cause there's so many direct-to-consumer commercials, which gives name recognition. So people are familiar with risankizumab or Skyrizi, or familiar with guselkumab, which named Tremfya, because you're, they're, they're so often seen on tv. But the reason why this is important is that outside of that first 1998-all-the-way-to-2014 revolution of the Infliximabs, people know it as Remicade or Humira. That then became this Skyrizi, Tremfya, Omvoh revolution, and there was some smattering of new drug orals, as I noted. Rinvoq is another one that you see on TV often, and so you're getting a taste in the consumer space about the immense amount of therapies that are available... yet the problem is, is that at diagnosis, less than 15% of Crohn's patients are offered or given an approved advanced therapy, and in ulcerative colitis, less than 7% are given these approved biologic based therapies and small molecules.

Despite them being approved, despite the immense efficacy data we've seen on the safety that we've had these drugs for a very long time. Patients are walking around undertreated. Not treated, undertreated, not appreciating that we can do so much better, and having that dialogue with our physicians about the fact that, "I think there's a lot of new meds out there. Should I be on one of them? Am I a good candidate for one of these therapies?"

So I think it's great. To be able to see all the advances and super happy to always bring new stuff, and it's very exciting to be part of it, to be part of the clinical trials, to bring new clinically, clinical pearls from the trials. But we just need more people to actually get on these advanced therapies because we can't accept living in fear of not knowing when the next breakthrough or flare what we call, or, "I'm going to have symptoms tomorrow, I'm worried that I'm going to have an accident. I'm worried that I have to wear a protective garment or a diaper because there's no bathrooms on my commute to work..."

I mean, these are life-altering symptoms that people are suffering in silence and are not appropriately being offered or considering these advanced therapies that have a huge impact on some of these most burdensome symptoms. 

Sarah Jenkins: That's such good information. Thank you for sharing all that. And I have so many follow up questions for you now.

I guess my first one is, you know, from NAFC's standpoint, a lot of patients come to us who are just kind of starting their journey. So they might not know what they have yet. They just know they're experiencing these different symptoms. They're trying to figure out what it is. So I think this is a great conversation to have for, you know, those patients who are trying to get help who just don't know where to turn or what to even ask for.

But why do you think people aren't getting these meds? Is it because they're not talking to the right doc or they're not talking at all about it? Are they being misdiagnosed? What, what do you feel the issue is?

Dr. Dubinsky: So many, you know, different factors. But what I'd say the following is that I'll separate a couple things.

So let's talk about ulcerative colitis. So, you know, inflammatory bowel disease sort of gets two buckets, right? You've got your Crohn's disease patients and ulcerative colitis. They are unique in their own ways. Sometimes they overlap in the way they present. But most often they're distinct. They're, they're distinct in the way they come to medical attention.

When we talk about ulcerative colitis, I'd say the advantage of why someone gets to maybe be evaluated faster with UC is because all of us panic when we see blood in our stool. Automatically our minds typically go to cancer. Because you know, you're concerned that, "Oh my God, why do I have blood in my stool?"

Imagine being a kid who really thinks like, why do I have blood in my stool? I'm not going to tell my parents. It's, you know, embarrassing. And then the parents see blood spattered on the, in the toilet, you know, in the toilet, on the toilet bowl. And they're like, "Have you been having blood?"

You know, there's different, younger, you're sort of embarrassing. You don't know what to make of it, so you often don't even talk to your parents about it. But as we get older, we're so ingrained that blood means cancer, right? So, Sarah, the, I would say that people will go to the doctor when there's blood in their stool.

Now, it just so happens with patients with ulcerative colitis, in addition to blood in your stool, you tend to have many more trips to the restroom. You may be waking up at night, you may not even be able to make it to the toilet. So your deferral time, you know, your inability to actually make it to a toilet and risk of having an accident. Is something that brings people to medical attention. The urgency of uc often is such that even though there's diagnostic delay, I would tell you that blood usually brings people to the doctor faster.

 So that's ulcerative colitis. Now, Crohn's disease is unique in a sense that many patients with Crohn's disease don't have blood. They may have had a little bit of fatigue. They may have had three to four loose bowel movements, maybe having urgency, a little bit of pain. But they removed lactose from their diet or they adopted it, you know, I increased my fiber, or I decreased my fiber, or I added gluten, or I took away gluten, you know, and they've been told that they have lactose intolerance or they've been told you have irritable bowel syndrome, your pain, you know, you're not having blood, you're not running to the bathroom every five minutes, you know, you're not having accents, and people sort of get dismissed.

So I will tell you that Crohn's Disease. Is often delayed, more so than you see. So I just wanted to like state the facts around how people often walk around and may have been dismissed. So you asked about are they, you know, not getting to the right doctor. It's also when you look up on WebMD or when you look up, you know, certain symptoms, the alarm symptoms are blood in your stool, right? Go talk to your doctor if you see blood in your stool. So that's why Crohn's may get a little bit of a, of a delay. But once you start having accidents and urgency or incontinence or bowel leakage or fecal seepage you can't tell the difference between air and stool.

And so, you know, you're starting to talk to a whole other level of not just a diagnosis, but the burden on one's mental and physical wellbeing goes down a completely different path. And that, I think, you know, patients feel that they're not being heard, and no one's taking my symptoms seriously.

There's a lot of that that may happen if they're just not in the right GI office, if that makes sense. 

Sarah Jenkins: Do you feel like most patients who start to seek treatment are going to a PCP who maybe doesn't understand all the intricacies of diagnosis, or is it a lot of the time in a GI office? 

Dr. Dubinsky: First you'll see there's a couple ways you'd come to a gastroenterologist. One you'd be referred by your primary, because you kept, you know, telling them that you're having loose stools, you're, you had no infection, right? We'd say someone would typically run a stool study to make sure you don't have infection like a bacterial infection or neurovirus before they typically send you to a GI.

As long as you don't have blood in your stool, that's one, that's been happening for a while. As long as you don't have significant weight loss, as long as you're not vomiting. Those are like red flag symptoms. So the majority of patients won't have something that you need to go to an emergency room.

I'll talk about that. You know, that's a different pathway into a gastroenterologist of course, but that usually is more someone who's been suffering for a long time or had, like, overnight, they went from normal stooling to every hour and they can't keep up with their liquid or you know, hydration or they're having a lot of blood or blood clots, then people are very concerned and they'll go to an ed, but the majority are searching online what my symptoms are, and when you have bloating, loose stools and cramping, irritable bowel syndrome, lactose intolerance, everything's going to come up if you sort of search on chat, you know your, your symptom complex. IBD would be there, but you should probably see a doctor if you have a, you know, they all the caveats around when you should see a doctor. So the majority will call up their primary or on their annual will be asked, oh, have you lost any weight or have you noted you're a little bit more tired? And they may get some annual blood tests and they're like, "Wow, there's an you're anemic. Did you know that? Are you seeing blood in your stool?" "No. But  I've noted I've been a bit tired and I've lo lost like three, five pounds. I don't have the appetite that I had anymore." And the primary may do a few additional tests, or they're going to say, I think you should see a GI.

So it all depends on the red flags or the severity. So you're either going to come through your primary, you're going to go through the ED if it's significant, you know, or to a point where there's life-threatening, you know, complications or fevers or severe abdominal pain. Or you know, somebody who had the same symptoms and was diagnosed by Dr. Dubinsky three weeks ago with Crohn's Disease, and you're going to pick up the phone, you're going to call and make an appointment with the GI, you know, so there's so many different pathways that people come to medical attention.

What we do know is that most IBD patients are suffering for a long time before they may see the gastroenterologist, whether it's because patients try themselves to change their diet, which we see a lot and say, well, you know, if I don't eat as much gluten or if I don't eat as much spicy food, I may not have as much symptoms, or my blood is intermittent, so I didn't think it was anything big. My dad had polyps, so I wasn't, you know, there's so many, I mean, you can't even create the permutations of the way that people sort of approach their health and when they finally get to a GI.

So, the first problem is delay in diagnosis, and we know that a delay in diagnosis impacts complications and outcomes. So for example, in ulcerative colitis, a longer time to diagnosis is associated with a fourfold increased risk of needing surgery to remove your colon.

Sarah Jenkins: Wow.

Dr. Dubinsky: Yes. So delay and procrastination and, "Oh, I'm not sure. I think it's a fissure," or "I was told I had hemorrhoids" and I'm like, "Did the doctor ever examine you?"

"Nope. They just said, oh, you're a little bit constipated every once in a while, maybe you have hemorrhoids. Take some Miralax or Metamucil."

Again, these are all sort of what happens in someone's journey, and it's not because the primary isn't, doesn't care about the symptoms in any way. It's just that the story isn't an automatic in most primaries, office IBD in the US is about 3 million people, right?

IBS is probably 10, 20 times that, which is irritable bowel syndrome, which is more of a sort of brain gut, we call them disorders of gut-brain interaction. So it's more stress and worry that is associated with pain, and more associated with what we call like more, you know, behavioral interventions or cognitive behavioral therapy, et cetera, to try and reframe the communication between your brain and the second brain in our body, which is the GI tract.

So that often is a more familiar term, IBS than IBD, just because. Out of 10 people that walk into a primary office, 10 out of 10 are not going to have IBD if you have diarrhea, right? So there's so many different nuances that create this delay, and listen, Crohn's is not immune to it either. The longer you wait to diagnose Crohn's disease, which I noted before, is more of a delaying process even than you see, because blood is not necessarily the driver to the doctor's office.

We know that we operate. A lot more and remove intestinal segments in Crohn's patients the longer they are without therapy. So that's the first delay is even the diagnosis. The bigger issue, which is where there must be change goes back to what I was saying to Bruce is that despite the commercials and despite the incredible data we have and safety of these incredible advanced biology-based logical anti-inflammatory therapies, the majority of IBD patients are not on these drugs.

So you asked Sarah why? Well, usually it could be information or education. And or probably the more likely is perceptions on safety. And unfortunately that, you, we all are fearful of unknown side effects. 

Sarah Jenkins: Yeah. So perceptions on safety from the patient standpoint, not from the physician?

Dr. Dubinsky: Both.

Sarah Jenkins: Both. Okay.

Dr. Dubinsky: Both. So. In the IBD space, so, okay, so general gastroenterologists are making the diagnosis because you're referred from your primary, it's rare that you're referred from your primary to an IBD Center of Excellence, for example. Right? Because we often see patients who already have an established diagnosis who are not responding to original, or someone calls up and says, I just diagnosed with Crohn's two weeks ago and I need to come to Mount Sinai. And so that's okay too. But typically we are seeing patients who need a second, third, fourth, eighth opinion because they have sort of burnt through all of the therapies that they had worked on with their, with their physician.

IBD based on the commercials you see has become so. Complicated because we don't just have Remicade anymore, right? We have seven different things we can choose from on a given day. So if you were a general gastroenterologist and let's say eight out of 10 people who walk into your office don't have IBD and you know, sometimes your, you know, there's a lot, we do a lot of endoscopy, so we may not even be able to keep up with all the literature. We not, may not be at every meeting that is presenting all these incredible trials that are happening. So. I may stick to what I know, meaning I've been prescribing Remicade or Humira since 1998, and then, you know, from 2007 on for Humira or Vedolizumab. I'm pretty good at that. I've known that for a decade plus, and I'm comfortable with it. The newer therapies sometimes are hard to keep up with in terms of where do I position them? What's the better drug for this patient. So that personalization can sometimes get lost. People aren't aware of, for example, Omvoh or mirikizumab, which was the first study to look at bowel urgency and fecal incontinence as an outcome of interest for patients.

So there's so much information overload that we may not be as up to date on the safety across all these drugs. And so where are patients getting their information from? 

Sarah Jenkins: It's tough because, you know, patients obviously need this intervention and need this treatment based on what you said, the implications of not getting treatment sooner can be really severe.

So, yeah, hopefully we can help a little bit educate, educate some patients on how to push past some of those barriers. 

Dr. Dubinsky: Because you can imagine that if the drug is approved and the data is strong, why wouldn't, why would less than 15% of the 50,000 or 40,000 newly diagnosed Crohn's disease patients a year, why wouldn't they all be on an effective, approved advanced therapy. Why less than 15%? That doesn't make any sense. And also, by the way, it's not just an American problem, it's a world problem, European as well. But the idea that I think the, that's why I think fear or perception of safety and or just keeping up with all of us being able to keep up with the literature can sometimes cause a delay in getting some of these newer based therapies that are safe, have no black box warnings, right, that don't increase the risk of cancer, that don't increase the risk of serious infections.

Why are we not getting that information directly to the patient on day one? And to be fair, there was a study last year that was published that said, when you use an advanced therapy within 15 days of a diagnosis of a Crohn's disease patient, you change the trajectory of that patient's life. 

So we are now clear and honestly, like I'm always like, I, we need to take a, an add out on Times Square, some PSA, public service announcement that says, I don't actually care which drug you use first because they're all approved, right? What is important is you get on an approved therapy for your disease. That's all that matters. So the idea that it's prognosis and your trajectory for your life is tied to early effective intervention. That alone, the concept of you're diagnosed with this, you should be on an approved therapy, and you don't need to suffer.

So I have patients where they would come in and they would be on a certain therapy and I'd say, "How come you're not on an advanced therapy?"

“I don't know. I, every once in a while use a suppository to help me with the blood or urgency. I occasionally wear a diaper if I can't make it to the toilet." And I'm like, just in your mind, you're like, how is this possible? How are you not offered or being on a therapy that addresses these with much more vigor and robustness? Why are we here?

And patients would say to me, "Really? This is not normal?" Meaning "I could get better? I've accepted that this is just how it is," or "I didn't think I, my doctor never brought up to me or asked me whether I'm having urgency or wearing a diaper or not able to make it to the toilet. I thought I was the only one, so I never brought it up."

Sarah Jenkins: I can imagine... and this kind of leads us into our next topic, but the embarrassment that goes along with that too. We've done so many surveys about bladder and bowel incontinence and what patients go through and how they feel, and it's such a hard topic to bring up to anyone, even your doctor. What kind of advice would you have for patients who are struggling with that? 

Dr. Dubinsky: Yeah, I mean, we've, you've done surveys. You know, we had a study called the CONFIDE Survey, where we anonymously asked IBD patients around urgency, around incontinence, around the impact of those two important patient reported outcomes on sexual health, on quality of life, on social life.

And it wasn't until we asked it anonymously did we find out, imagine Sarah that in my clinic, I, I consider myself pretty empathetic, very connected to what matters to the patients. I, until this CONFIDE survey and had the, the gift of being involved with this at the level that I, that I was. I never asked a patient the severity of their urgency.

I would just say, do you have urgency? Yes or no? That was it. We walked away. We're like, okay. We didn't ask, well, how severe is your urgency, for example, and because urgency could be mild. None. All the way to worst possible urgency, which typically means, you know, I should be asking them, are you having accidents and are you needing to wear a diaper?

It was not until this survey where I was so shook, you know, as a provider, and this is, this is something I've done for almost 30 years that I wasn't connecting at the level that my patients needed me to be. So the idea that, no, my patients weren't volunteering that, "Oh, I have accidents. I can't make it. I don't go out. I'm not intimate with my partner. I have to wear a diaper." It wasn't until this survey that we have a mandate, a responsibility to our patients now to normalize it or validate that this is something that can happen. If we know about it, there's something we can do about it. And I think that de-stigmatization and what the CONFIDE survey, and then again, I was noting that mirikizumab or Omvoh, actually for the first time ever as a key endpoint in a trial cared about the most burdensome symptom patients have, which is bowel urgency, remission, meaning resolution, or improvement in bowel urgency. No trial until recent time had asked whether or not the most patient-reported burdensome symptom actually changed with the therapy that was going to be approved for patients with IBD.

I mean, think of all that's happened just in the last few years. Where have we been? Right? So that's why I say that, we now, it's uncovered, it's been brought to the surface. It would be shame on us to not validate how our patients feel and make it seem like this is what most the majority of patients with these diseases suffer from. If we know about it, we can help. 

Sarah Jenkins: Yeah. Yeah. That's really impactful. And, yeah, something that we hear all the time, you know, how hard it is for them to just go about their daily lives because they're just so scared they're going ot have an accident. Bowel urgency and fecal incontinence are really the biggest drivers of that. So thank you. 

Dr. Dubinsky: I would, I would want to add also that it's interesting so we get even the endpoints in our clinical trials, by the way, are very rudimentary. Does your colonoscopy look better? Okay. That's important by the way. 'cause you know, if your colonoscopy looks better, chances are you'll have less blood and you'll probably be running to the bathroom less.

That's for an ulcerative colitis patient I'm specifically talking about. But the idea that until more recent time, we were assuming that drugs work fine as long as they just address number of trips to the bathroom and whether you have blood, so that we didn't even account for pain and we didn't account for urgency until more recent time.

So every drug from 2005 on for ulcerative colitis, which was in Remicade in 2005, the first advance for UC is the idea that it wasn't until more recent time where we actually asked these important, you know, questions. So I think, the idea that we're finally focusing on what matters most to the patients and the agencies like FDA and the European agencies are actually wanting us to bring patient reported outcome as key outcome targets for drug trials and actually focus on making sure that patients function, that their overall wellbeing and function and no disability, et cetera, fatigue pain, urgency, all of that. The fact that we're having this conversation now, I mean, we're a lot into the advanced therapy era, but to be honest, thank goodness that this conversation, you know, is actually happening, which is allowing us to, to validate our patients.

I'll never forget conversation I had with a 19-year-old who was in a dorm. She had had severe ulcerative colitis and was suffering. But like every freshman wants to be normal, wants to live the life of a freshman in a dorm. But because she had to share a bathroom, she was a 19-year-old wearing a diaper.

You don't forget when you're examining or talking to a patient and me saying to her that this is not okay. Her emotional response, which of course, you know, you get emotional around it when you're, when you're talking about it to my core, again, when I say I've been shaken by this, you know, conversation that we now have brought to the forefront that when you validate a young individual that this is not going to be your life and shouldn't be... that's the magic of really that patient, you know, physician relationship where you have trust that you understand, that their life is not defined by the colonoscopy, which is a very important add point for us. But my patient's life is defined by, can I leave the house? Can I go on a road trip? Can I go on vacation? Can I throw my kids' birthday party? Can I maintain a job because I can get out of the house and be there on time? Those are what we need to be striving for. Now, the good news is when we do improve things like the intestinal lining and we focus on colonoscopies to make sure our patients are good on the inside, 'cause that's very important too, what we're now doing, finally bringing the fact that patients want to feel and function at the highest level possible, and we're focused on making sure the insides are good as well, that that is finally being combined and looked at as what we call composite. Meaning we want your overall disease, both how you feel and how you look on the inside to actually match so that people could live their best life and function at a level that is what they need to be able to live their best life. 

Bruce Kassover: So, Dr. Dubinsky, so I'm listening to what you're saying and it's really, if I were a patient who has Crohn's disease or UC, I'm very encouraged by, you know, the treatments that are available now and, you know, the sort of prognosis that you're talking about.

And at the point that I'm sitting in front of you as a patient, I mean, I've either already had some of those alarm symptoms that have really, you know, sent me or it's been building for so long that I just can no longer live like it anymore. So, you know, sort of overcome a lot of that fear and concern and embarrassment, you know, to get me sitting in front of you, what I want to talk about are those patients who are not that far yet, patients who are experiencing symptoms, but they may not be so alarming or you know, so life limiting that they feel like, "Oh, I have to go see a doctor now." Now all of us have had experience with, you know, occasionally you'll have, you know, some sort of a digestive issue, you know, because you ate the bad fish or whatever it is, and you know, that's normally not going to send you to the doctor.

What's sort of symptoms should I be looking for or frequency of symptoms? What should I be paying attention to say, "You know what, I shouldn't wait. I should just suck it up, deal with whatever embarrassment there is, and go and ." 

Dr. Dubinsky: Yeah. I think, you know, so you're talking about like you noted, not someone who automatically needs to go see a GI immediately because there's alarm symptoms, which is not the majority. The majority is what you're asking me. People who may have increased stool frequency or may have a little bit of blood every once in a while, thought it was a hemorrhoid skin tag. No weight loss.

Occasional cramping gets better when I take milk out of my diet. All of that, I think the key is duration, Bruce. So it's not necessarily the height of the alarm symptom, it's how long has it been going on for? I mean. To have intermittent, when I eat this, every time I eat shrimp, I have this symptom. You can make that correlation. You don't need to see a gastroenterologist. You could avoid shrimp, you know, as an example. But if you have ongoing chronic diarrhea or chronic abdominal pain, you want to know that it isn't. Some kind of inflammatory disease. You want to know, is it irritable bowel syndrome? Whereby every once in a while I get a little bit of pain. I get some bloating, I have some diarrhea, but I'm not losing weight and there's no blood. And yeah, I've been stressed a lot and at work, or I'm, you know, it's difficult for me to focus or I'm absent from work. I'm not even present when I'm there, you know, all of those and work productivity. If it's impacting you, whether it's IBD or IBS, you need to see a gastroenterologist, they can help. Because even in the IBS space, there's a lot of patients who are bumped from the primary back to the GI. GI says, "You have, I scoped you. There's nothing going on. Go back to your primary." Primary says, "There's nothing I can do for you. Maybe go see another gastroenterologist."

So I'll be honest that a lot of patients with irritable bowel syndrome are ping ponged between GI who say there's no IBD here. There's nothing bothersome. You don't have celiac disease. You need to just go see somebody about your stress level. And then the primary who isn't qualified necessarily to treat irritable bowel syndrome is saying you need to go see a specialist.

So the good news is, is that there are more and more specialists also in irritable bowel syndrome, meaning these function or dysfunction of brain, gut interaction. There's many of them. There's like. Functional indigestion chronically. There's just chronic diarrhea. There's chronic constipation.

There's a whole group of gastroenterologists out there that are very focused on helping people with these non-inflammatory bowel diseases, but more irritable bowel syndromes that people can seek help. So my opinion is if it's impacting your life. You've tried everything possible and nothing's changing, you need to see a professional. And online advice is probably not going to get you very far. And you really want to make sure that this is isn't IBD. You want to make sure it's not celiac. You want to make sure that there's nothing else going on. And I think the only way to do that is to really see a gastroenterologist.

Bruce Kassover: Now, if I'm somebody who does have, you know, say mild or medium level symptoms, are some of these new medications that you're talking about also appropriate for me or are they really reserved for more substantial cases? 

Dr. Dubinsky: So substantial is in the eye of the beholder. So what does it even mean to have substantial?

This is the other myth, is that there's this conceptualization that if my symptoms today are mild, I will always have mild disease. And you know what? It's not that bad. I could take a suppository or I just stop eating gluten. Same story I said before. It's the same story. So, I'm fine, doctor. I don't need any of your infusion stuff. I don't want to give myself a shot. And you know what? That I'm not sick enough. And so there's a difference between disease activity, which is how you are at that moment. It's a cross-sectional evaluation, either by looking at your scope, looking at your symptoms, looking at your labs. I am making a decision at that moment in time on your activity that is not the same as severity.

Severity takes into account your prior history with this, with this disease. How you are active today, whether you failed multiple treatments, yes or no, and we have ways of predicting. Who is at risk of surgery. So what you are asking me is whether or not a perception of my disease activity is the same as dictating whether I need a therapy that is approved for someone who may be more moderate to severe, and a patient perceives themself as I've got mild symptoms.

I know somebody. Who can't leave the house. I know someone who had three surgeries. I am nowhere near that. Well, activity does not define what, whether you need a treatment or not. So the whole idea of making treatment decisions, which we do every day in our, in the clinical trials, because we say you meet a certain disease activity level, let's say, 5 to 10 as opposed to a 4 to 1. And people will say, well, I'm, how do you grade me? Am I 1, am I a 10? You know, again, so it's hard to like, well, are you talking activity? Are you talking about what I think your prognosis is going to be? Or are you talking where I think your treatment needs to be? So I wanted to really clear up that how you feel today is not, should not drive what treatment you need to be on. And we've got two categories, very simple. I either have mild to moderate or I've got moderate to severe. And again, that's just based on how you are today. When you go to an experienced gastroenterologist, who knows what are the factors that you may have that predict that you're going to have a severe flare and we're going to pre-emptively intercept that because we know that you have certain factors in your family history, in your past history. You have joint, you have skin rash as well. Whatever is happening. That's how we determine treatment. So one of the other things that we're going to put up on Times Square, other than "get a diagnosis and get onto effective therapy early," is that we need to be better in understanding that how I feel today is not what dictates what treatment I need to be on.

There is much more of a conversation and understanding things, how these diseases impacting your life. And I'll be honest with you, when you start digging into urgency, incontinence, fatigue, pain, you're automatically step up into the fact that this drug is impacting your overall functioning and you need to be on an effective therapy.

Bruce Kassover: That sounds, that's also important and encouraging. You were talking earlier though about when you were talking about the medications, about one of the big things that may prevent people from getting some of these treatments is concern about safety. So maybe you could talk a little bit about the side effect profile of some of these and whether or not that really does rise to a level of concern for some people.

Dr. Dubinsky: Yeah. So just a reminder that the number one risk factor for safety, is the disease itself progressing. So there is no drug whose safety trumps undertreated inflammatory bowel disease, period, full stop. The biggest risk to patients is actually the disease itself not being treated appropriately.

So what people most concern themselves with is, does this drug increase my risk of cancer? Does it lower my immune system? Will I get infections? None of, you know, our drugs we wouldn't have drugs that are approved, that we've been using, you know, for almost three decades with like we're talking denominator of exposure or years of patient exposure in, in multiple thousands or hundreds of thousands that we wouldn't be prescribing them to two year olds, right? I mean, the reality is we just need to be open and honest and know that these rare safety events that we see are really aren't ever, you know, equal to the risk of surgery, the risk of an ostomy bag, the impact on urgency, the impact on not being able to, you know, get up and go to work, et cetera.

It, it's, there is none that really would negate in someone who needs it to be on it. Now, I understand it's fearful. I mean, I treat kids and the label for Remicade in 2006 said that adolescent males have a higher risk of a rare type of lymphoma. I'm the one who is managing patients when that came out in 2006.

So I understand that to talk about risk and it's all relative, and when you say that the risk is one in 10,000, the risk is one in 5,000, and you compare that to the daily risks of walking on the street or driving a car. It's all relative, but again, it's all in the communication style and an understanding about these very rare risks that, yes, some of our drugs have these labels that, that describe the risk, but as I said, you have an informed risk benefit discussion with your patients. And like I said, the risk of under or not treating moderate to severely active IBD is riskier than any drug we have, and in the clinical trials, the newer generation of drugs have a better safety profile than placebo.

And why is that? Because when people get placebo in a clinical trial, they are undertreated. And so it's not shocking that when people get placebo in a trial, their disease can worsen. So I think it's just being in front of the right people, having the right education, being informed and empowering people with information that's accurate and true. 

Bruce Kassover: That's really fascinating and very encouraging to hear. So if I'm a patient who's taking one of these medications, if the commercials are to be believed, if I've had a, you know, mild to severe you know, medium, whatever my risk is, I can now start to, I can go canoeing and I'm going to be boating and I'm going to be hang gliding... in the real world, what sort of effect do these medications have, I mean, how successful are they at treating these symptoms and the underlying disease? 

Dr. Dubinsky: So if you look across all of our drugs and drug trials, you're looking at about around 50% of people at the end of a year in a clinical trial reach the endpoint of the trial, meaning to be clinically well in what we call remission.

Now, clinical trials are not real life scenarios because in real life we use drugs a lot earlier. We also are able to adjust the dosing in a clinical trial, it's all fixed. You can't make any protocol changes, et cetera. So to be fair, whatever is described in commercials or whatever you read about in package inserts, actually for most of our drugs, it's even better in the real world and real world evidence, remember, clinical trial, the maximum amount of people they could study is around a thousand. But in our practice, or once a drug is approved, we're talking thousands that are exposed to these drugs, right? So we get a lot of experience on safety and efficacy in our real world practice. And since we don't wait and we don't get placebo in clinical practice, we always have better outcomes in clinical practice than we do even in clinical trials.

So I think it's a matter of finding the right physician, finding the right expertise, having a open and honest dialogue about what the burden of this disease is, making the right decision early, getting on an effective therapy, understanding whether they want to have children, because some of our choices will depend on family planning, some of our drugs we don't use in women who are immediately planning a family versus if it's in five years from now, we can use any drug. So the nuance, if you're 65 and above. What's the data on? Am I at higher risk of having infections because I'm older? Are you younger? Is there any risk specifically to young versus old?

Literally, the day a drug comes out, it's never the patient that's in the clinical trial. So you need to immediately be in front of the right physician. So if I'd have to say probably the most important message is get the right diagnosis. Get on the right therapy, make sure that they're, you're monitored closely, and be able to have an open and honest dialogue around what are the risk benefits of either undertreating or not treating, versus being on effective therapy and understanding what your short-term and long-term risk is specifically related to the disease, more so than these rare risks that we see with our therapies that are approved.

Bruce Kassover: That is very sound and sensible, and I hope that people actually pay attention to it. Now, I can't imagine anybody we've spoken to who is better positioned to ask this speculative question to you. Imagine that you were to suddenly be able to transport into the future 15 or 20 years with all of these other research efforts and things in development, how much further do you think we're going to be along the path towards really super effective treatments? Where do you think we're going to be in the future ? 

Dr. Dubinsky: We have super effective treatments right now. If they would just be used early and appropriately, we'd be good. But of course, exciting clinical trials are happening.

There will be multiple new drugs. I mean, I think there's 40 active clinical trials as we speak, imagine, and that's because there's still people who at the end of the year, 50% of people are not responding to the therapy that they are in clinical practice. I already laid out in the last hour, all of the reasons why probably, but there's always room for innovation and more targeted therapies and more precise therapies.

We're combining therapies, so there's a lot of excitement for the future, but essentially over the next 10 years, we already know in a couple, in five year, four years from now what the next drug class is going to be. There's three in clinical trials as we speak right now for the same class, which will be interesting and great to see how it compares to the drugs we have now.

There will be some interesting work being done on whether we can prevent or detect disease even earlier, sort of like what Type 1 diabetes has been able to do to look at what if we are able to find people with active inflammation without even needing to come with symptoms, but using things like ultrasound in the clinic, measuring risk factors and people who are first degree relatives.

So there's a whole parallel movement in whether we can actually intervene before someone needs to come to the doctor with diarrhea, rectal bleeding and urgency. So we're actually moving into this precision and prevention landscape. So while that's happening, new drug development, novel ways of delivering the therapies we have, combining therapies, looking at the role of GLP-1 in inflammation and the role of obesity, I mean, it is immense. Like the amount of work and focus and excitement around what the future holds is amazing, but the future is here. We have incredible therapies that have been tested for almost three decades, some of them. And so like I said, if anything comes out, it's less about all the amazing things that will happen in the future... we have 3 million people who are suffering today, and we need to make sure that those that are still seeking treatment or are still suffering, that we make sure that they actually get access and are on the right therapy to help them get back to living their best life. 

Bruce Kassover: I can't think of anything that's more encouraging than what you were just saying, and that's really got to... anybody who's listening who's in doubt or unsure should just take those words to heart and really do something about it.

But as you know, this is Life Without Leaks . And one of the things we always like to ask our guests before we go is to see if they have any little bit of advice, a hint, a tip, a strategy for our listeners to live a life without leaks. So I'm wondering if you might have one that you could share with us today.

Dr. Dubinsky: Yeah, I mean it's sort of keeping theme with what we were talking about. I just think that we need to demand our patients need to demand that we focus on what really is important to our patients, and that is literally living life obviously, without leaks, and focusing our attention on making sure patients don't suffer unnecessarily and really don't need to accept a new normal, and we need to help them define what normal really means for them. 

Bruce Kassover: These are really, really powerful and compelling words of wisdom from you. So I really want to thank you for joining us and for sharing with us today, all of this information. I certainly hope that people pay attention to your message and go out and do the right things for themselves, for their health, for their family, and loved ones. So, so really thank you for joining us, Dr. Dubinsky. 

Dr. Dubinsky: Thank you for having me today.

Bruce Kassover: Life Without Leaks has been brought to you by the National Association for Continence. Our music is Rainbows by Kevin McLeod. More information about NAFC is available online at nafc.org.