Supporting a Caring Health System
This week I am talking to Collin O’Neill, the CEO of Pilleve (@Pilleve1) and Gautam Chebrolu, the Founder and CTO of Pilleve a company addressing the devastating effects of the opioid crisis with innovative technology built to work within the existing pharmaceutical distribution systems.
The company’s early roots came from personal experiences bound together with a desire to solve the problem from a bio-medical engineering perspective and that of a front line pharmacists. As they describe the problem the sourcing of these drugs in many cases originates form what you could call a legal path with over 12 million misused opioid prescriptions and in 2018 over 70,000 opioid related overdoses many with tragic consequences.
Many of these drugs enter the system through ‘Diversion’ through multiple roots – in fact Colin shares one of the stories where they were able to demonstrate the caring system and solution and alerting a mother to diversion that was going on with her prescribed medication that she was previously unaware of. There are some important side benefits of this approach that starts to influence behavior of people to help them reduce their dependency on opioid medications reducing the risks and allowing those that need access to appropriate pain relief to obtain it easily. In fact in the case of the elderly this new style container is not only child proof, but like many of the existing alternatives, actually easy to use and open to get the medications out. You can watch the process here
With the Pandemic one of the drivers of increased use and abuse of opioids has seen a dramatic increase – depression and loneliness further compounding an already huge problem impacting our society
Listen in to hear how they have integrated their solution into the existing workflow, providing additional value to the medication process and offering new insights about patients actual use of drugs that includes timing of medication and real time feedback on its impact on the patients condition.
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Raw Transcript
Nick van Terheyden
And today I’m delighted to be joined by Colin O’Neill is the chief executive officer of pill Eve. And Gotham Chabrol Lu, he is the founder and chief technology officer of pill leave Gotham column. Thanks for joining me today.
Colin O’Neill
Thanks for having us, Tucker.
Nick van Terheyden
So as I do with all of my guests, I think it’s always important to get a little bit of the background Gotham, I’ll start with you, because your founder on the organization, tell us a little bit about your background and how you arrived at this point, if you would.
Gautam Chebrolu
Yeah. So I studied biomedical engineering. And I know a lot of a lot of people in our audience probably have a healthcare background. And personally, I actually didn’t think about starting a company, I’m relatively young. And when I met my co founder use of alpha Naui, we ended up meeting on the point of our own personal experiences with substance abuse. And that’s either personally or with their family. And at that point, it was really just we wanted to do something because we kept hearing about the opioid epidemic. And we decided, why don’t we just start a project? Why don’t we try to include friends and family members, because the key term that kept popping out to us was early intervention. And so we just want to do something. And then we just kept on working on it. Starting talking to a lot of doctors, a lot of pharmacists, a lot of patients, everywhere, all these stakeholders, and we started to realize that we actually had something of value. And then that’s when we just went for it.
Nick van Terheyden
Fantastic. And, Colin, tell us a little bit about your background and how you ended up here.
Colin O’Neill
Yeah, I’m a pharmacist of about 2020 years at this point. And I had just wrapped up my MBA at Babson up here in Boston and the Wellesley area was working with mass challenge. And both you surfing goethem had approached me with this idea. It really seemed to resonate with me just based on my experiences and seeing how the practice in the professional pharmacy kind of reacted to the opioid epidemic, this is a great opportunity to move something along that could have significant impact in in trying to combat that. And so it just kind of blossomed from there. I started as an advisor for about a year I was chief operating officer with them for about a year. And now, I recently took over as Chief Executive Officer for about three or four months now.
Nick van Terheyden
Fantastic. So help us understand set the stage. I mean, I think people know, but we’ve I think partially lost a little bit of sight of the challenge of the opioid epidemic, because we’ve got a pandemic on our hands. But this continues, you know, it doesn’t matter what else is going on. We have the challenge of the opioids, we’ve had some recent announcements, I’m not even sure where we are with some of the settlements, we’re not going to cover any of that. But tell us some of the sort of compelling statistics around this epidemic from your perspective, as you’ve seen.
Colin O’Neill
So you know, in 2015, there is over 12 point 5 million misuse the opiate prescriptions, and in 2018, there was over 70,000, opioid related overdoses. So in these numbers continue to grow in so there isn’t more recent published information on this, as we continue to interact with different doctors and different patient groups. This is a continuing challenge that hasn’t been met. And one of the things that we find interesting is the the clinical need hasn’t really changed, there’s still a need for investment in that space, to help improve patient oversight, help build communication, the relationship between their prescriber in the patient and the pharmacy.
Nick van Terheyden
And as you think about the contributory causes, and I know there are lots of them. Tell us a little bit about where you think if there is a majority, or maybe it’s equally spread what what contributes to this opioid epidemic that we’re seeing.
Gautam Chebrolu
There’s, there’s just so many and I think I think that’s one of the core ideas behind this is that we need to start understanding the individual or understanding the root cause for each individual, because it may be different. And so that’s kind of built into the design. And I know I’m jumping the gun a little and talking about what we’re doing because that’s all I think about for the last four years. But it’s it’s all about how do we get just an underscore staining of the patient. So we can go from there. And that’s the baseline. And so some people might have taken oxy cotton from an uncle, when they were hurt playing tennis, or someone might have used it recreationally with a group of friends, before they knew the total risk of it, or maybe they were prescribed it. And so there’s so many different entry points, that all we know, as at this point, we need to make sure to help the people that need to get help.
Nick van Terheyden
And I think you’re teasing out something that, you know, sometimes strikes people as unusual in this space. There’s a significant proportion of people that are not buying or getting these drugs, illegally, so to speak. And by that I mean, they’re not going and buying it across, you know, some street corner or that process, it’s coming through what I would call regular channels, is that true?
Gautam Chebrolu
Exactly. And that’s, it’s a little bit of mix here, because there’s this data that we have, because, of course, the data is not gonna be perfect, it’s going to be usually from the National Survey on Drug use. And so it’s going to be a little bit subjective, and it won’t hit every single marker. But we actually do see that a majority of people who end up abusing heroin later in life, they actually start off with the prescription pills, but they also have majority of those of that proportion, actually get it from beg, borrowing and stealing. So in a sense, it may not be illegal. Sometimes it’s not perfectly legal, if that makes sense.
Nick van Terheyden
Interesting. So what you’re saying is beg borrow and steal, is the on ramp to some pretty significant challenges for individuals around opioids and abuse of drugs.
Gautam Chebrolu
Exactly. Because we, from our understanding of the problem, the biggest source of extra pills in the community is diversion. And so it’s people who have legally obtained prescriptions, and then those pills somehow get out into the community. And so, yeah, and that’s something that’s kind of lost in the narrative about the opioid epidemic.
Nick van Terheyden
So Colin, you you’ve you’ve practiced as a pharmacist, you’ve obviously been, you know, knee deep in this knee deep in pills, let’s call it tell us a little bit about your experiences on the front line, what did you see you, I’m guessing lived through some of this experience? From a pharmacist perspective, were you seeing these this activity? Or was it was it hidden. Um,
Colin O’Neill
so I’ve worked in a variety of different settings, retail hospital, long term care, nucular at a variety of different levels from, you know, student, intern, pharmacist, management, director, VP, all these different roles, and it permeates throughout a couple of different things, or I guess there’s a couple of different aspects to take into consideration. Some of it is kind of hidden and kind of within the system, General healthcare system. But there’s other things that you see, especially in the retail setting, you know, cash paying customers coming in on a regular basis, picking up large quantities. And so, you know, being able to identify those patients connecting with those doctors, and then within the pharmacy industry itself, being able to alert you know, authorities as to, you know, things that you might think would be illegal activities, like fake prescriptions, and things like that. So these are things that are, these are hidden things, these are things that are out in the open and I think remain out in the open, but are kind of swept to the side. In some cases, I think it’s business oriented. I think sometimes, you know, it’s customer service oriented, but I don’t think we’re doing a very good service for our customers if we’re helping them with a problem, or a diversion of narcotics.
Nick van Terheyden
Alright, so substantial problem are clearly multiple on ramps, you know, I think, diversion of existing supply with let’s call it legal supply for the purposes, and I know there are variations on a theme here. But you’ve developed a solution that really goes after that in an unusual way. Tell us about the genesis of that and where you are with that Gotham.
Gautam Chebrolu
Yeah, to be honest, the first the first idea that we came up with was just a way to connect friends and family, because it was all about a support network, because when it we were also seeing all these studies about how maybe when people were getting addicted in West Virginia, that part of that opioid inclination or inclination to use opioids came from depression, which also came from loneliness. And then there were also studies in rats showing that we brats didn’t have a social network around them that that’s when they would actually get addicted to these certain substances. And so there’s so many more sociological and psychological factors in this. And so that was a real critical idea for us. But then, as we started talking to more and more people, we realized that the doctors should be in the know as well, because the doctors are the ones that are providing the care. And if we can just understand exactly how patients are using their medications, we can definitely intervene as early as possible. And then, of course, on the side benefit of that of what you’re just mentioning with diversion, that if we know exactly where those pills are going, then we know where they’re also not going. And so they’re not going into the community, which I believe is, at the end of the day, the most important part.
Colin O’Neill
Yeah, and kind of building on what Goldstein was saying, you know, it’s about right sizing the prescription. And that’s done by improving the communication between the patient and the physician right now, when the patient picks up that prescription at the pharmacy, they go out into the community, it’s almost an unknown for a couple of weeks until the office either follows up or the patient comes back for a follow up with our platform, the patient’s able to accurately record know their experiences with the medication and provide feedback around you know, how many tablets are utilizing our goal is not to kind of regulate the patient or prevent access. In fact, it is the opposite of is safe, it’s there to actually improve medication access, especially in patient populations that require regimens that are outside of the usual guidelines, a lot of these patients have been cut off or dose reduced through their primary care or through their pain physician. And that doesn’t stop the their need for pain relief. And so they’re going through other channels, sometimes not legal channels, to find those medications. And it just adds additional risk for receiving care that they shouldn’t have to take on, at least here in the US in this day and age.
Nick van Terheyden
So for those of you just joining this week, I’m joined by Colin O’Neill, the Chief Executive Officer of pill Eve and Gotham chamber, Lew, the founder and CTO believe we were just talking about their device. We’ll include that in the show post that goes out. But it’s focused on impacting that source of diversion and the original way in which some of these drugs enter an abuse opportunity. Colin was just describing, you know, the multiple variations, I think at this point, it would be really helpful to explain the device. So I’ve had the fortune of trying this out, I think, clever, intuitive. Tell us a little bit about this.
Gautam Chebrolu
Yeah. So from a technical standpoint, and then call him can go more into the clinical. But to think underlies every single part of the of the device is about how we’re, we’re integrating into existing workflows. And so if we start with the pharmacy, we actually made sure that our device is just an attachment to existing prescription vials. So pharmacists spend almost no more extra time and just screwing it on to prescription vial that’s already filled with medication like oxy codeine, then they simply flip it over, put a prescription label on it, and hand it over to the patient. And so now the device is attached to the vial. And then whenever the patient wants their medication, we simply go into an app, and then enter in some basic information. So firstly authenticate themselves with something like biometrics like face ID, or touch ID, and then simply input information like a pain level, and then press a button to send a Bluetooth signal to the device. And the device just dispenses one pill at a time. And then by by doing that, we’re able to get accurate and real time data that we collect, and immediately send it over to our web portal that physicians can access at any point. And then also, we have some kind of alert. So if there’s a tamper event, for example, if someone messes with the vial and opens it up when they’re not supposed to, then we get an alert, and that automatically sent so we understand exactly what is happening at any point. So just to recap real quick, is that for the pharmacists, it’s pretty much exactly the same as they are just replacing their normal vial cap with our device, the patient, it’s actually I broke my arm before years ago. And it’s actually easier to open up to get a pill out of our device than it is for me to like, try to squeeze open a normal vial and get a pillbox and so they just press a button on the app. And then for the physician, all the data comes to them in real time and they don’t have to waste time educating the patient or wasting a lot of clinical time. That’s better. bent on doing their job better.
Colin O’Neill
And then kind of turning the page into the clinical implications. You know, first and foremost, for the prescriber and the practice, you know, they have better insight into how the patient is utilizing their breakthrough pain medication, whether it’s in a post surgical setting, or in a chronic pain setting, they have an idea of, you know, the access. And then also, in chronic pain, patients, usually on multiple medications, usually a long acting med. So as they’re titrating the patient up or down, if they’re trying to taper, they have an idea of how often the patient’s accessing that breakthrough pain medication. And then, you know, for the patient, we found that it actually gives patients pause for thought, just just the the knowledge that you know, it’s being recorded. And that we’re trying to fish out functional, subjective pain levels, it kind of improves the, I think, the feeling of care and concern this there, but also give some positive thought before they take the medication, we’ve had a couple of patients where we observe where they started to decrease their medication or breakthrough pain medications slightly, and it’s taken on a slightly higher patient reported pain level. And so it’s kind of an interesting kind of paradox that we saw there. And we’ve seen this now a couple of times. And so I think it’s just knowing that someone’s there, that they can keep track, sorry. So knowing that some the platform is there to help them kind of keep track of the utilization at a personal level, and then knowing that they’re connected to the prescriber, to kind of a digital level.
Gautam Chebrolu
And to emphasize fascinating This is that a lot of these patients Khan is talking about, they had been on opioids for years, and they had been taking a pretty consistent dose. But then after the surgery is done, that’s when we actually started to see a slow decrease.
Nick van Terheyden
You know, it’s really interesting, it brings up a couple of points. So the first off, and I think it’s worth emphasizing is that this is a standardized attachment to existing, you know, pill bottle technology. So it’s, it can be widely distributed. It’s also interesting to know that Gotham must have received an alert when I tampered with the device, you can’t let me know. So sorry about that. But that’s me, I used to take things apart, can’t help myself. But I you know, as you highlight, you know, a couple of things. Some things really strike me one, this is actually a positive for the elderly, who struggle with these really difficult, you know, and it’s child safety, which is appropriate. But I saw this with my own mother a real challenge. And here we are with a solution that is actually directed somewhere else, but I think is going to solve the problem. But I think it’s really interesting. When you start to monitor and I know people go well, that’s big brother and but it’s not as Colin rightly highlights. This is caring, and and having somebody actually paying attention. When you have a full bottle, you just go Yeah, sure. I’ll take her I feel like Gregory household, you know, taking my tick taxes he seemed to but when somebody is monitoring, and you’re reconciling that against pain level, and what you’re saying is you’ve already seen a decrease, correct?
Colin O’Neill
anecdotally, yeah, you know, we’re in the middle of a variety of different pilots, University of Washington, OSU, Johns Hopkins, and we recently started working at UMass out in Worcester. And so some of those are post post surgical studies. And so we’re noting that, you know, the patients being discharged with a 30 count of oxy code on five milligrams, and you know, the average utilization is there in small patient population so far as between zero and five tablets. And so these are a significant number of tablets that are that are going out in the community. And I think you touched on something really important, Dr. Nicholas, this is this is caring. We haven’t used that term belief, until you just mentioned it. But I think, you know, one, a great example that we ran into was, we add a tamper tamper event through our platform. And so we just reached out to the patient to try to figure out what was going on if they’re having any difficulties with with the device. And she had said that the device wasn’t with her that it was at home. And so that but she also said that, that her daughter was home. And so it kind of put a red flag off to have you know, had that discussion at home about you know, the medication and who was taking it and kind of dig into that a little bit more. And so there’s all sorts of things that we kind of stumbled on. We’re still very early. We’re still ironing out a lot of wrinkles and discovering a lot of things and in what areas you know, this technology can can benefit the Facebook and libre scarb in the most, but we keep stumbling into things like that. And this is just an area that’s been stagnant in pharmacy delivery of pharmacy care for quite a while. And medication adherence really hasn’t moved ahead. Despite a lot of great efforts out there. I think this is another another angle of approach that maybe we can get some traction and jumping forward a little bit. And that’s why I’m really passionate about being part of leap and you need to invest time and energy here.
Nick van Terheyden
You know, that’s the last foot couple of feet, it’s you know, from hand to mouth that we’ve just not had. And, you know, there’s been other solutions around this, and you still don’t know if they took it out and took it. But you at least know that they dispensed it, which you know, we know 50% of medications don’t even get filled, let alone taken, that are prescribed and you know, I’m basing my clinical decisions upon 50% people taking So, you know, extraordinary value. So let’s talk we’ve got a little bit of time. What are the sort of economics of this? How do we get this so that it’s widely available? It’s, you know, probably not going to be on everything. But you know, where it makes sense? How, how’s that going to work? And what’s the future hold?
Colin O’Neill
Yeah, we continue to build our book of business, the the model is pretty straightforward. The devices currently $50 for the device, and there’s a subscription service for the planning to access data for $20 a month. And there are a bevy of remote patient monitoring codes that are out there that can be leveraged. And so I actually just ran some ROI numbers this week, and have a patient We’re sorry, in the clinic where two users with just one patient, we think that is between 12 and 13 $100, that they can recover after internal labor and cost of the device and cost of the subscription. And so there’s a pretty good return on investment that’s in there as well, as well, alongside the clinical value of just having better oversight and better knowledge of what’s going on with the patient.
Nick van Terheyden
So clear economic value that, you know, presents, I guess, an easy decision for people to think about Gotham in the last few minutes. Where do you think this could go? What are the opportunities?
Gautam Chebrolu
Yeah, we really do want to become the gold standard for all controlled substances. And we’re making a lot of changes on the application as well as the twice just to make sure we can adapt to more and more situations. Because I think at the end of the day, it’s it’s a, it could be a tool to do patient engagement. And to make sure that we’re understanding, like, we keep going back to it being a caring platform of understandings. And one quick story that I’ll say that because I’m really customer service. And it’s all about trusting the patient and building that trust between the patient and the physician. Because in today’s opioid crisis, that we actually see that you almost have to be suspicious of the patient out beforehand, and then build the trust. But we want to reverse that. And so we also think, looking forward on the horizon, that things like benzodiazepines and Adderall, and methamphetamines, those are the next epidemics that are going to happen. And we’re not paying attention to him, but they’re already happening right now. And so we are always keeping our ear out for those. And
Nick van Terheyden
so I think, you know, truly fascinating, and I would take that and say, Gosh, not just controlled substances, I think there’s real value to this, I think you can see the economic benefits, literally just of knowing I mean, from a caring standpoint, but also from economics, why bother prescribing something, why fill it, if you’re not going to take it, we don’t want to wait, we see all this automated refill in the industry that is driven by economics and say if I refill it, I get paid, because I’m in the pharmacy benefit management, all of those things that I think will drive additional opportunity. It’s giving easier access, it’s giving a caring sense around this that, you know, starts to focus. And as you pointed out with the rats, you know, people that are lonely and don’t have any friends around them are increasingly at risk. And guess what happened in the pandemic, we saw that extensively. So there’s huge opportunity for this for what is I think just quite frankly, brilliant design to allow for a capability to use it in different settings, different utility. And I love that story. I know, whoever that individual was, is eternally grateful to discover that you know, something is going on at home that they would not have known about. So already one life that’s prevented or at least you’ve got an opportunity to play intervention. This is an exciting story. I’m glad to be here at the beginning. With it with you at the beginning of it. Just grateful you’re able to make the time and indeed, handmade device. I’m just sorry you didn’t fill it with m&ms instead of real drugs, but that’s okay. Unfortunately, as usual, we’ve run out of time but exciting journey. Glad to be here with you. Thanks very much for joining me. Thank you.
