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"State of Glaucoma Therapy: 2012." George A. Cioffi, MD (Columbia University Medical Center) delivered the inaugural Glaucoma 360 - New Horizons Forum keynote lecture in San Francisco on February 3, 2012.
The keynote started a full day of presentations and panel discussions on innovations in glaucoma. New Horizons Forum is presented annually by Glaucoma Research Foundation.
Adrienne Graves, PhD: Well, let’s get the program started. We have a true glaucoma star, Dr. Jack Cioffi, setting the stage for us. Dr. Cioffi’s career has really spanned most aspects of the glaucoma world. He is an internationally respected researcher, who’s work influenced, and helped shape, the very definition of glaucoma as an optic neuropathy. He is a distinguished surgeon. He is beloved by his patients for his skill and his care, and he is a talented professor, as well as a very talented administrator and manager. He has served very successfully as chief medical officer at Legacy health, and he is a senior VP and the CMO there, and the RG Chenoweth Chair of Ophthalmology as Devers. Now, I’ve known Jack since 1991, when he was a fellow with Mike Van Buskirk at Devers, and I knew instantly that he was going to become a star. Yes, his stellar path is continuing, as he is set to become the chair of ophthalmology at Columbia University. Please join me in congratulating, and welcoming, Dr. Jack Cioffi.
George A. "Jack" Cioffi, MD: What I wanted to do over the next few minutes is to talk a bit about where I see us at right now, but you’ve seen the lineup after me. We have an amazing faculty, and they’re covering virtually every burgeoning topic in glaucoma therapy, so I’m really the appetizer. I’m not going to give you a comprehensive review of every single medication, or every new development. What I did want to do is, I wanted to talk a little bit about what I see as shaping the future of glaucoma care, and how we springboard from where we’re at right now, the state of glaucoma therapy 2012, to where we’re going to go. I’m going to give you three things that I think are shaping it already, or will shape it in the very near future. Of course, the Yogi Berra quote below, ‘It’s tough to predict the future’. [“It's tough to make predictions, especially about the future” - Yogi Berra]
So where are we right now? For several decades really, and refined over time, we’ve had a glaucoma therapeutic triad of topical medications largely, laser trabeculoplasty, and incisional surgery. We talk about this, we talk about it with our patients. It really has been the mainstay for quite some time now. The beauty of it is it’s actually incredibly effective in the vast majority of our patients. We stop a lot of people from going blind over time. There also have been a lot of substantial improvements, mainly in safety. You can look in the medication, you can look in each one of these. We’ve got drops now that you take once a day, with really minimal side effects, compared to just 15, 20 years ago. We’ve refined trabeculoplasty to be better and better, and new lasers, and safer. We’ve actually made great advances in incisional surgery. Every one of these has significant drawbacks, not only the cost drawbacks, the financial side, but also the clinical cost, because of complications and side effects. I think it’s highlighted by the fact that we take care of a chronic disease. This isn’t something that you fix and you’re done with. This is something that you’re treating patients for a decade with. It’s the beauty of why I like to do what I do, but it’s also a bit of the curse of glaucoma. This is something that’s gone on and on. What are some of those drawbacks? Well, you know them. We have a terrible delivery system. We rely on patients to take their drops and to get them in their eyes. Success rates with the laser are variable, and duration is often short. Then of course, there’s some horrendous side effects to incisional surgery that we haven’t eliminated. They’re still out there, such as endophthalmitis.
What do I see as shaping where we’re going right now then, if that’s the backdrop, if that’s the mainstay of therapy? I think there’s three things. First, there’s health reform, financing reform, and information technology, which I’m going to talk a bit about. That’s a short-term. It’s actually more than a short-term, it’s right now, it’s happening right now. Because of that, I have more slides about it. There’s the near term, and that’s the novel therapeutics. In this one, I’m not going to into every novel therapeutic, but I’m going to use drug delivery as an example of where we’re going there. I don’t have as many slides because it’s a little more unknown. Finally, where I think we’re going, and we’re going very quickly, is so-called personalized or targeted therapy, and I’ll talk a bit about that in just a couple slides.
OK, so finance reform, and this is not a political statement. This is not, I’m not leaning right or leaning left here. I just want to talk about what I think is going on right now, and what we’re experiencing. There’s a lot of people that say whatever happens in the elections in the fall, that will all change. I don’t think it’s going to change, because I think the horse is already out of the barn, and there’s parts of it that are colliding very quickly on the reform side, on the payment side, and especially on the information technology side that I think are somewhat irreversible. It’s felt throughout medicine. It actually, traditionally, has been felt a little less in ophthalmology because, largely, we run on the side of medicine, but I think we’re creeping up on it. I’m going to talk about information technology, and there’s a good side, there’s a bad side, and there’s a really ugly side to information technology. The parts of the good side are the fact that data acquisition and data sharing is actually, for the first real time, going to allow outcome studies to be done outside of major trials, which is a big deal. We haven’t really had outcome studies it the past. I’ll talk a little bit about the HITECH Act, which has accelerated this, and EMR adoption. You know, I heard a statistic a couple years ago, that one in 12 imaging studies, this is all imaging, body imaging, and one in nine lab studies are repeated, because you don’t have the availability of information. I bet it’s not that different for ophthalmology, frankly. How often to you repeat a visual field because it can’t get sent over from somebody? Or, how often do you do you actually send out some blood work because you don’t have it for somebody else? With information technology, though, comes scrutiny, and it’s scrutiny on two fronts, I think. Payer front, and we’re going to have to think about that as we go through the day, and also the public front, and I’m going to show you an example. I think financing’s already affecting us, no doubt. You know, look how quickly the adoption of generics have happened in the last few months.
This is the simplest slide I could find of the Affordable Healthcare Act, and it’s not simple. There are a lot of moving parts. I’m not putting this up, this is a summary from a group called Premier. I’m not putting this up so that you memorize any part of this, only so that you recognize that we’re already two years into this. A lot of these lines, we’re already progressing down. Here’s a little bit easier slide of some of the things, healthcare exchanges, in our state, it’s up and running. They’re up and running overall. I want to pull out a couple. This year, hospitals are being mandated to go public with data. We’re all going to be mandated to go public with data very quickly. Here’s another one, bundled payments. I think this is actually may have the biggest bearing on glaucoma therapy as we go forward because we’re a chronic disease, and chronic diseases amend themselves terribly well to a bundled payment, and we’re going to have to figure that out as we figure out how to pay for better therapies as we go forward. The final one is, there’s not only going to be bonuses when you do these things well, but there’s going to be reductions when you’re in the bottom quartile, and it’s only data acquisition that will allow them to track us.
There’s a lot of stuff happening. Why is it happening so quickly? It’s happening quickly because of the HITECH Act. The HITECH Act is, was basically simultaneous with the Affordable HealthCare Act, and that is, it’s to stimulate the adoption of EMRs. We’re paying providers to adopt EMRs, and there’s provisions for hospitals, there’s provisions for doctors, to put EMRs into place. These payments, actually as of a couple weeks ago, have already sent out, the federal government has sent out $2.5 billion in payments for this, of an estimated $27 billion on the horizon, so it’s already happening. I bet if we take a survey of the ophthalmologists in the room, I bet a fair number of you already have adopted EMRs because of this, or your institutions are. It’s been an unprecedented rate, and it had been stagnant for largely two decades prior to it, especially in ophthalmology, because the systems aren’t great for it.
Anybody in the room know who this woman is? It does look, you know, when I first put it up there, I thought it was Adrienne Graves. It’s not. I will tell you that I believe this may be the most influential person in the future of medicine going forward. This was actually, I pulled a few clips, this was actually in The Times a few weeks ago, this story. This is Judy Faulkner. She is the CEO of Epic Systems. Epic Systems, the picture there is their campus in Verona, Wisconsin, which is this backwater about 30 miles outside of Madison. It’s a huge campus. It’s like a college campus, a 6,000-person auditorium. It’s huge. They now supply EMRs to all these, and many, many more institutions. Over a quarter of a million doctors are on Epic. This is a private company, guys, started in the late 70s, and it’s estimated that about 40 percent of patient’s data that’s on an EMR is on Epic. I don’t know to be, I don’t know if I admire her, or if I’m scared to death of her, but you should know who this person is, and there’s a huge power in Epic and some of the other big folks.
We not only have had a huge adoption of information technology and systems, but we’re also seeing a finance reform. What finance reform has meant to me is they’re trying to put more people into the system. The tens of millions, and you can argue about what the right number is, but a lot of people are trying to be put into the insurance system, meaning that there’ll be more people to care for, meaning more people with our chronic disease. The other things that’s working against us if you will, is the changing of the U.S. population. This is from census data from 1990, this is what we’ll look like in 2050. There’s 90, 1990. There’s 2050. We’re going to have a huge new population. These are the folks we take care of. The red at the top, are those the 60, 70, 80-year-olds that we’re all taking care of in our office right now, and it’s just exploding. Why is that important? Because chronic diseases cost the most money, and that’s why I believe they’re going to be the target of most finance reform going forward. Here’s an interesting statistic. If you have five or more chronic diseases, glaucoma being one of them, that group of patients makes up for three-quarters of the Medicare budget. That’s huge. You can see, each one of these points is in a time point, its whether you have zero chronic diseases, one, two. If you go from zero chronic diseases, you almost triple when you get one chronic disease. 2700 bucks? That’s about what it costs to take care of a glaucoma patient in some years, right? It’s reasonable. Usually, when we think about chronic diseases, we’re thinking about congestive heart failure, but we’re one of them too.
What’s happened? All these new businesses have come in. This is an example of a business called Prometheus. They’re talking all this information that’s being saved, and they’re trying to, this is great euphemisms, they’re trying to encourage physicians, hospitals, and other providers, to work as a team centered around each patient. Well, duh, we do that right? What they’re really looking at is how to avoid cost. That’s what these systems have set up, and they’re doing data management on everything that’s being collected on Judy’s systems. What else is going on? Have you guys seen these before? These are so-called Dartmouth atlas maps. These are utilization maps. We’re all being judged right now on how much we utilize. Well, guess what? These maps have been generated over the last couple decades at, from Dartmouth med school and public health. They’re really hard to get to when you don’t have outcome data. They’re really easy to get do when you have data. All of the sudden, they’re going to be able to tell each one of you how much you utilize, how much you utilize for your patient, whether you’re an outlier. I’m moving from the lowest utilization state, pretty much, to the highest utilization state, so, I guess we’ll be a focus soon.
What else is happening with all of this data? This is an email that I got a few weeks ago. “Dr. Cioffi, have you seen your profile on Avo [Phonetic][15:43]?” I have no idea what Avo is at that point. I’m thinking, hm, I’ll bite. I’m competitive, I want to know, and so I pushed the button. I wouldn’t have shown you, by the way, if it was a bad score. I got this, I have no idea. They had stuff on me. They had where I went to grade school in this thing. It was ridiculous the amount of information that’s out there. I know that, in the Bay Area, actually, Yelp is fairly big for physician ratings. There’s even Craigslist and all for rating physicians. Data acquisition, IT, the availability of data, is out there, and it’s happening right now. I still don’t know who Avo is.
I didn’t mean to be a downer at the beginning of the morning, and that’s not my point. My pint is actually summarized nicely here in a New England journal article from a few years ago, and that is, despite all of this, despite an explosion, the columns sort of in the middle of the graph here are people going to the internet for information. Despite all of that, overwhelmingly, patients trust their doctors for information. They may go, they may come in with the legal-sized paper asking you questions, and they may go the internet, but they’re still looking to you. Believe me, if you have a bad Avo score, whatever that is, I bet they’re not going to come to you in the first place.
OK. Healthcare reform is happening. It is in full stride. EMR adoption, I think, is actually a good thing. Outcomes data is where we’ve wanted to go for a long time instead of claims data. Patients are living longer. More and more patients in the system. They’re chronic diseases that, including glaucoma, that we’re going to see are more costly, are more frequent, and are targets for reform. That said, with all this explosive growth, patients continue to turn to us for answers, and that’s the good thing, and that’s why we’re here today.
Where are we going in the near team, then, with all of that as a backdrop? We’re going to have to talk about how we pay for these things going forward. Let me touch on novel therapeutics. As I said, I’m going to use drug delivery systems as a surrogate for this. Here’s a couple articles from Friedman, from Hopkins, Dave Friedman. When we have to write papers and guides about how to manage non-adherence, you know that we probably have a problem, right? That is that people probably don’t take it. Actually, the best example in medicine that I like to use is non-adherence to kidney transplant patients. That is, if you’ve had a kidney transplant, of course, you have to take anti-rejection medications, and it’s estimated that there’s significant non-adherence with those things that you, will force you to lose your kidney, or die, in 22 percent of patients, and that it contributes to about over a third of graft rejection, of kidney rejection. If they’re not taking their kidney anti-rejection medication, do you think they’re really taking your glaucoma medication, if you rely on them as the vehicle? I’d say it’s not. There’s been a huge number of innovations around this field in the last few years, and this is just a partial list of nanotechnologies and delivery systems. I’d say the take home here is we thought this would be easier. We thought we’d put something in the puncta, or on the eye, or maybe even inject it subconjunctivally and that game would be over. Those lymphatics that weren’t supposed to exist, do, and we haven’t got it in. Thankfully, what’s happened in the same space is that our retina colleagues have shown us that it’s actually pretty darn safe to inject, they seem to be injecting like every other day, but inject medications in the eye frequently. I, my crystal ball says that we’re probably going to move from non-adherence to adherence with an injectable, and probably an intraocular injectable. I do believe that, that went backwards. I do believe that non-adherence and poor compliance is a huge issue for us. We’ve got to solve this one, and whether it be with a safer surgical procedure, an injectable medication, we have great platforms right now. I think it’s the near term. I think it’s the big next step for glaucoma therapy, just as prostaglandins were, just as surgical procedures were in the past, I think it’s coming, and patients are going to come to us for answers.
Let me close up by the idea of personalized targeted therapy. I think in the not-to-distant future, we’re going to know what somebody’s lamina is reacting like. We’re going to know how their vasculature reacts to a medication. We’re going to know how they scar or don’t scar. It’s going to, not only are we going to know that about the patient, but we’re going to know the genetic background to them. The availability of genetic testing on beta blocker responders, for instance, is just exploding right now. We’re going to move, as that happens, from trial and error medicine that we’ve been doing, to more personalized, or individual, therapy. I think that this is a bit longer term, but we’re not far from it.
We’re going to know how people’s IOP reacts. This is a huge issue for us. This is, I borrowed this from one of our scientists Crawford Downs, this is a continual IOP monitoring. We check IOPs, you know, every three, six, 12 months and we think we have a number. This is a primate eye, a real-time EKG on the top simultaneous with the IOP down below. You can see that the IOP goes from 11 to 30 in a matter of moments as this animal moves around the cage, or blinks, or stands up. We don’t know what the IOP is. We need to know what the IOP is so we can individualize therapy. The other thing that’s happening is medical knowledge is exploding. This is a paper from Lancet a few years ago showing the explosion of randomized controlled trials. We know more about our disease than ever before.
In conclusion, the therapeutic triad, if you will, has been an incredibly great mainstay for the majority of our patients. It’s not enough. There’s too many drawbacks and we have a chronic disease. The future is now. You shouldn’t be depressed by the information age. You should be excited by it. I think what we need, and what we’ll hear through the day, is we need effective, safe, affordable, applicable to many, because we’re going to have many more patients, suitable for chronic disease, but most importantly, acceptable to patients because patients continue to turn to us for answers. Thank you so much for inviting me. I’m thrilled to hear the rest of the day. Thank you.
Last reviewed on May 17, 2019