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Hello, and welcome to Episode Sixteen of Multiple Sclerosis Discovery, the podcast of the MS Discovery Forum. I’m your host, Dan Keller.
This week’s podcast features an interview with Dr. Revere “Rip” Kinkel about how to improve patient outreach. But to begin, here is a brief summary of some of the latest developments on the MS Discovery Forum at msdiscovery.org.
First, researchers are questioning if cognitive MS is a distinct entity. For some patients with MS, cognitive symptoms dominate over all other symptoms. Some of the symptoms could even be described as dementia. Researchers examined a small sample of this distinct subset of patients in a recent study in Clinical Neurology and Neurosurgery and found that many had severe brain atrophy and a high lesion load. While the results suggest that cognitive MS may be a distinct disease entity, the researchers are cautious not to draw any conclusions due to the small sample size and the weight of the term “dementia”.
An experimental oral agent for the treatment of relapse-remitting MS looks promising as it progresses through clinical trials. The drug, currently called RPC1063, was shown to be both safe and effective in a sample of about 200 patients. It may even be safer than fingolimod, which is currently the only oral drug FDA approved for the treatment of MS.
For women with multiple sclerosis, pregnancy is especially tricky. In a previous news synthesis, science writer and immunologist, Griselda Zuccarino-Catania, looked at many challenges for women with MS who are trying to get pregnant. But postpartum can be a tumultuous time for MS patients as well, since the risk for relapse increases after delivery. In this part of her series on pregnancy and MS, Zuccarino-Catania explores the current research on postpartum relapse risks, breast feeding, and disease-modifying therapies.
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Now to the interview. Dr. Revere—or “Rip”—Kinkel is the director of the multiple sclerosis program at the University of California, San Diego. He is also the chief medical officer for an initiative managed by the Accelerated Cure Project, our parent organization, to establish an MS patient-powered research network. He sat down with me at the joint ACTRIMS-ECTRIMS meeting in Boston earlier this year to discuss how to improve patient outreach.
Interviewer – Dan Keller
Welcome, Dr. Kinkel. You are now interested in new models of care. What do these entail, and why do we need them?
Interviewee – Revere Kinkel
Well the traditional model is, of course, the patients coming into a clinic setting at a variable interval and having a diminishing amount of time to spend with a physician or any other kind of provider that they are seeing. Going forward in the future with fewer neurologists, fewer MS specialists available, we need to find ways to reach larger populations of patients. Whether that be through Internet portals, whether that be through outreach, through community clinics where we travel or whether it be through telemedicine or a combination of those things. So we are particularly interested in developing tools and models that allow us to reach patients in this way.
MSDF
What are some of the ways that you reach them: go out in the community or how do you specifically reach people who would not typically be contacted?
Dr. Kinkel
Currently we are doing a number of things. The first thing we have done is we have developed a virtual MS center online called HealthCareJourney.com which allows patients anywhere to sign up, ask questions relevant to their disease and the problems that they have and get answers. Both the questions and the answers are posted online for the entire community to see. We are also trying to find ways, particularly in California; this is true around the entire country, but particularly in California, to outreach to communities. What we have noticed with the transition with the Affordable Care Act is that a significant number of patients have been switched over to Medicaid programs. In our case we call it Medi-Cal in California. Many of these patients have been away from doctors for many years, off drugs for many years. They are not aware of services that are available to them. Many of them don't speak English as a primary language. We recognize the need to go out to the communities, have community outreach programs to reach these individuals, to do mini consults, tell them what kind of services are available, try to connect them to those services and then get them to come to our centers periodically and work with their local physicians.
MSDF
Do they typically respond well to this, or are they at all wary of what you are doing?
Dr. Kinkel
Well we haven't started doing it on a large scale basis. This is actually in the planning stages for next year. Interestingly we have kind of noticed this over time with drug company sponsored programs. So many of us will do these education programs for patients where we will go out and meet with a large group and we are always intrigued by the interactions we have one-on-one with the patients afterwards. That is when we really find out the issues they have and they start to hear about the things that are available for them and their eyebrows go up, they are interested, and you hear from them again because you can help them. That kind of setting has shown us that this kind of reaching out to communities helps. What I am talking about is going a step further; which is reaching out through community health centers, through other advocacy groups to find even less advantaged patients that might not have been even going to these kinds of programs and helping them, but also, including them in the process. Right now we have an understanding of MS that is based on a population that primarily goes to tertiary care centers, which is highly over-represented by Caucasian well-educated upper middle class individuals. We have far less of a knowledge of the needs and requirements of the less fortunate.
MSDF
Have you heard it all or can you discern anything from reaching out to these people and what they tell you that is either surprising or new?
Dr. Kinkel
I am totally amazed at kind of the lack of information they have. Just from basic MS-101. So you have to start there. Many of these individuals have kind of higher needs. When you have the needs of just putting food on the table and paying the rent and trying to make sure their children are safe, MS takes a back seat. Often in many of these families you see the effects of MS on the children, much as we see in all populations, but it is particularly acute on those individuals with less resources available to them. So there is a greater community need for support for these individuals both in terms of real services as well as in terms of education.
MSDF
What are you getting out of PCORI? First of all can you define what it is, and what sort of resources they can provide you?
Dr. Kinkel
PCORI stands for the Patient Centered Outcomes Research Institute, and the Accelerated Cure Project has a grant to develop a 20,000 patient centered research network. I am the chief medical officer for the PCORI Initiative. This will allow us to reach a large population of patients, but the challenge, much as I said a second ago, is reaching those individuals that might not even use the Internet or the web that often. So we need to find ways to not only include the traditional MS patients we see in many of the tertiary centers but also to reach out to these communities. What we intend to do with this reaching out is to get patients involved in the PCORI Initiative as one of the main things that we do when we reach out to the community. That will allow them a forum for describing their experience and potentially getting further resources available to them.
MSDF
If they are not presenting to healthcare facilities, how do you reach them? Do you go to schools and get parents of kids or churches, or where do you get the word out?
Dr. Kinkel
One of the advantages that we have now when the law of the land is that everybody has healthcare insurance; is that we can actually track people. It is interesting. What happens in many communities is the physicians don't accept Medicaid for instance, some don't even accept Medicare. But what they do is they will accept this when patients are acutely admitted. The scenario that we hear over and over again is these patients go to a healthcare facility when there is some kind of an acute decline in function. They get taken care of. They have a diagnosis code of 340 for MS attached to them, but then they are discharged with no followup plans. They are actually not seen again until there is another acute decline in function. Well, we can identify them as soon as they are identified as a number 340. Once that is done, then we can reach them for these community outreach initiatives.
MSDF
Is this purely for diagnosis and treatment or can you do this for research? Do you get information from this?
Dr. Kinkel
What we do is we outreach to patients and provide education. We do not initiate a patient physician relationship without their approval. So you reach out to those individuals. There is no problem with that. They have to make the step of following through and initiating that kind of an interaction. They also have to make the step of deciding that they are willing to participate in something like the PCORI Initiative. All we can try to do is be as persuasive as we can and educate them about the benefits to both them as well as the greater society.
MSDF
Do you find that there are people who don't even recognize a symptom? They just think their arm is numb because it must have been something they did at work and pass it off?
Dr. Kinkel
Oh yeah. It is an interesting phenomenon especially when things have been going on for a long time. If an individual is born blind, they don't see being blind a problem. If for the greater part of their life they have noticed that they have numbness in their feet, sometimes they don't mention it, because they don't consider it a problem. We always find that when we are seeing patients for the first time, they will describe these vague neurological symptoms that go back for many years.
MSDF
Tell me about the OPT-UP project?
Dr. Kinkel
So the OPT-UP project is just a part of the normal evolution of the Accelerated Cure Project. The Accelerated Cure Project was developed to have a repository of well characterized patients with their biological samples for researchers around the country. We recognize that there were issues with the repository. We didn't have good longitudinal samples; we couldn't guarantee that we had samples on patients before and after they went on drugs so we could look at biological responses. So the OPT-UP study was to address that as well as the need to begin to create an environment where we were combining clinical and research activities to get more patients involved in research activities. By that I mean we know very little about long-term outcomes in MS. Part of this is because there is no coordinated manner to collect data longitudinally that is agreed upon between all of the clinicians that are caring for these patients. So we wanted to kind of operationalize that process so that we could follow these long-term outcomes and collect them. By doing so, we can answer a lot of questions that we have. For instance, in the near term with the OPT-UP study, since the only requirement for the study is that a person be initiating a drug, whether it be for the first time or for the tenth time, they are just initiating drug. One of the things that we will learn is; what are the reasons why people start drugs, what are the reasons why they stop drugs, what are the reasons why doctors are putting them on this drug or that drug. We know very little about that. What we really do know still is that a tremendous number of patients at least 50% discontinue a drug within two years of starting it. If we don't first know exactly why this behavior exists, it is hard to keep patients on therapies for a longer period of time, and to see which therapies are going to be most beneficial.
MSDF
Will this go on indefinitely?
Dr. Kinkel
It is a long-term study. The duration of a study is always dependent upon a number of factors; funding, interest, but yes we are building in a number of mechanisms that allow us to follow patients for a very long time in the study. Probably the key to this is a dedicated nurse research coordinator at each site that will be responsible for entering and following patients over a period of time. And when sites exceed a certain number of patients then they hire another one, because what we have discovered in the past from the many research studies that we do is there are competing interests. Whenever we try to continue to follow people for a long time, other interests win out. There is no one there to kind of encourage the patient to continue their participation. The studies that have been more successful – a long-term study like the Nurses' Health Study – they are able to do that primarily because they put the resources into ensuring that, that experience is meaningful for the patients and that they will want to continue to contribute that data.
MSDF
Will this initiative also collect general health data knowing about comorbidities and be able to correlate those with the course of the disease?
Dr. Kinkel
Yes absolutely. It is one of the main things that we want to do. In fact, one of the reasons why pretty much the only inclusion criteria is, that a person be starting a drug. Most Phase III studies exclude people when they have other health conditions. This is why there is so little external validity to these studies. The way we gain that validity is to encourage those patients who do not normally contribute to clinical research to participate in the study, either because they don’t want to, they can't get to the site, or because they are excluded by the exclusion criteria.
MSDF
On these topics, is there anything important to add?
Dr. Kinkel
I think the most important thing to add is that we are entering into an era…we are already in an era in which technology is rapidly transforming how we reach patients, and we need to kind of embrace it. I see that many of my colleagues are reluctant to. I see it in their unwillingness to embrace electronic medical records for instance. They see it as a burden.
And it is true; there is some burdensome aspects to it. I believe, however, in a world in which they have less time to spend individually with their patients in a clinic setting, in that kind of a world, they need to find other mechanisms to reach and meet those needs of their patients. One of the ways to do that is through these kinds of technologies. Using the website. I encourage them to send their patients to the healthcarejourney.com website for instance to get general information about MS so that they can reduce the burden on their own centers and their own staff with patients calling in with questions every other second.
MSDF
Very good. I appreciate it.
Dr. Kinkel
Thank you.
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Thank you for listening to Episode Sixteen of Multiple Sclerosis Discovery. This podcast was produced by the MS Discovery Forum, MSDF, the premier source of independent news and information on MS research. MSDF’s executive editor is Robert Finn. Msdiscovery.org is part of the non-profit Accelerated Cure Project for Multiple Sclerosis. Robert McBurney is our President and CEO, and Hollie Schmidt is vice president of scientific operations.
Msdiscovery.org aims to focus attention on what is known and not yet known about the causes of MS and related conditions, their pathological mechanisms, and potential ways to intervene. By communicating this information in a way that builds bridges among different disciplines, we hope to open new routes toward significant clinical advances.
We’re interested in your opinions. Please join the discussion on one of our online forums or send comments, criticisms, and suggestions to editor@msdiscovery.org.
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