Many people feel reticent to speak about their personal medical problems and for 3% of Americans, the problem is so extreme that they feel they cannot speak to a doctor at all. While most concerns lead to nothing serious, there will be occasions where an inability to speak up can lead to further problems. Empowering people to feel confident is important, and there are stages to breaking down the barriers to this.
One important step to creating a safer environment for speaking freely is through improving awareness over conditions. Simply put, there are almost no conditions that significant numbers of people won’t have experienced and that doctors won’t see as run of the mill. Diseases concerning sensitive parts of the body and, similarly, venereal disease, are a good example of this, with literally millions being diagnosed every year according to the CDC.Despite this, studies have shown that many men and women are reluctant to discuss their symptoms with doctors.Teaching awareness of these sorts of facts, and outlining how nobody is going to judge, is an important base layer.
Getting Information Out There
Part of the reasons some people will refuse to approach a doctor is through fear of diagnosis, or of invasive diagnostic processes. A great way to combat this is through having as much medical information available online as possible. Services like Mayo Clinic and Healthline have done a lot to aid this in recent years, but more work can be done, especially with more obscure conditions.
Most crucial is the process of de-stigmatizing all illness. Regardless of the cause, condition or outcome, illness remains the same and should be treated with sensitivity. The effect of stigma on illness is clearly felt. Anonymous polls of men by the NCHS found that 10% of men had experienced feelings of anxiety or depression, but less than half had sought treatment. This fear of stigma has led to men being 3.5x more at risk of suicide than women. De-stigmatizing is key, both for mental health and for conditions across the board.
Illness should never be something to be ashamed or scared of broaching the subject of. Instead, it should be something that people feel confident and free to talk about with a doctor, with no worry of abuse or shame. Through awareness, dispersing information and tackling stigma, society as a whole can create an environment in which people of all ages are happy to pursue their medical issues.
Dr. Danielle Brander explains why it’s important for chronic lymphocytic leukemia (CLL) patients to stay up-to-date on developing research and treatment news. Dr. Brander also shares resources for learning more about clinical studies.
Dr. Danielle Brander is Director of the CLL and Lymphoma Clinical Research Program at Duke Cancer Institute. Learn more about Dr. Brander here.
I think it’s very important that patients and their caregivers stay informed and advised of opportunities to participate in ongoing research. I think there’s a misconception that with all the favorable progress in treatment options available for CLL, that there’s no longer the need for clinical research participation.
Though, there are a lot of novel options available for CLL, there’s still a lot of ways that we can improve care for patients. That is, there are trials with the next-generation inhibitors or for patients traditionally with harder to treat CLL or may become resistant to the novel agents, there’s a lot of trials looking into how do you combine the novel agents to give patients the best options. And then a lot of the research, too, are not just in the treatments.
But as our science advances into looking at other markers of the CLL cells, or what we call the depth of response, how much CLL you kill with the treatments and how low of a level we can get in terms of detection. This may result in a situation where patients have the opportunity to receive novel treatments, have a really good response, and then potentially stop the treatments and be followed off of therapies, so have the benefit of novel treatment but not with having to go on an ongoing drug forever and ever.
When I talk to a patient about opportunities for clinical trials, I’m really focused on the patient in front of me. That is, I wouldn’t offer or talk about a trial if I didn’t think it potentially could benefit the patient in front of me.
And again, though we’ve had a lot of advances in treatment options, there are certainly a lot of ways that we can engage and hopefully help patients moving forward. There’s been recent studies across all cancers showing that unfortunately a very low percent of patients are offered and enrolled and participating in clinical research studies, and I think it’s really important that patients know there’s a lot of opportunities out there that potentially could benefit them.
The different ways to be advised and informed, again, are some of the resources online educationally for CLL and lymphoma that often post about different sites for clinical trials. There’s a clinical trials.gov web site that all sites in the United States that are enrolling trials with patients have to log clinical trials, and though that has to be updated, it often can be a good beginning site.
But in the end, hopefully the best resource is your treatment team, your oncologist, and your other team that can help point you to what trials might be eligible for you, either at the location where you are or close by.
The last part I’ll point out is though we focus a lot on the treatment clinical trials, in CLL, where patients don’t always need treatment right away or may have treatment and have a response and then have a long period of time afterward, is that many centers are helping to engage patients in research that is not necessarily done during the time of their treatment. Again, to try to understand why some patients have a longer course until they require treatment, or why they might have responded differently, or other ways we can improve their care.
https://powerfulpatients.org/pen/wp-content/uploads/How-Can-Patients-Learn-About-Developing-CLL-Research_-1.png600600Kara Rayburnhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngKara Rayburn2019-09-18 10:32:122019-09-18 10:38:37How Can Patients Learn About Developing CLL Research?
Three experts discuss the clinical trial process and the difficulty in participating in a trial. Our expert panel includes:
Ken Getz, MBA – Founder and Board Chair, CISCRP
Andy Lee – Senior Vice President and Head, Global Clinical Trial Operations, Merck
T.J. Sharpe – Melanoma Survivor and Patient Advocate
And greetings from Southern California. I’m Andrew Schorr from Patient Power. And welcome to this Patient Empowerment Network program, another in our series of Clinical Trials MythBusters. Our goal, of course, is to help you get the treatment for you or a loved one that you need and deserve. I want to thank the financial supporters for this program to the Patient Empowerment Network; AbbVie, Inc., Celgene Corporation. Daiichi Sankyo and Novartis for their support. They have no editorial control and we’re going to have a very freewheeling discussion today. And really what it’s about is how can a clinical trial be made easier for you to participate? Are there barriers? We’ve talked about it in previous programs. But specifically, what are the companies—the pharmaceutical industry mostly, who sponsor trials all around the world, what are they doing to make trial participation easier? For you to know about trials. For the people at your clinic to know about it and what to say and how to administer it. For you to have documents that are understandable for you and your family to know whether you want to participate. To keep you informed. And also related to the requirements of trials. How can they be relaxed a little so that there may be a trial that would benefit you, that you and your doctor agree on, and the requirements of it allow you to be in the trial. Okay, and the logistics of it are not so tough either. All right, I’ve been in two clinical trials, and I believe I’m alive today because of that. So, I’m very grateful. We have some wonderful panelists with us over the next hour. Now as you have questions, send them to email@example.com. And some of you have. So, you’ll be able to interact with us as we go along. First, I want to go to Ft. Lauderdale, Florida, and T.J Sharpe. And T.J. has been on programs with me over the years. Stage four melanoma patient having been in trials. And T. J., you would agree, you’re alive today because you were in trials, right?
Absolutely, Andrew. I think both of us are very fortunate that we found a trial that was the right treatment for us and gave us the ability to combat our disease in areas may not have been available to us if we just waited for standard of care therapies.
Right. And here you are—we should say that you were diagnosed a number of years ago with melanoma, went through trials. And now you’ve had two years without treatment, right?
Yes. It’s been five years of treatment followed by now two good years of a clean bill of health.
Well, great. And I should mention for our audience, many people are familiar with T.J. T.J. goes around the country, gives speeches. He’s been at many events, consults with industry that are developing trials to try to bring the patient perspective forward. So, T.J., thank you for all you do. We really appreciate it.
You’re welcome. It’s my honor to be able to represent all these patients.
Well, most every family—certainly most have been touched by cancer. But our other guests are not cancer patients but are in national leadership programs. And so, let’s go up to Medford, Massachusetts at Tufts University outside Boston, Ken Getz. Ken, welcome to the program. Ken, ladies and gentlemen, is a true national leader when it comes to clinical trials and really helping us move forward with better processes, better understanding. Ken, tell us a little bit about your organization there, CISCRP. What does that stand for?
Thank you. And I have to say your pronunciation was nearly perfect. It’s hard to pronounce it. It’s an acronym and it stands for The Center for Information and Study on Clinical Research Participation. It’s a non-profit organization. It was founded 18 years ago. And it’s really there to help patients and their families navigate the whole clinical research progress which for many is completely unfamiliar terrain until they’ve been diagnosed with an illness or when they have exhausted all other treatment options. So, CISCRP really helps people become more educated and informed so that they can really think of the clinical research process with more confidence. And they can navigate this unknown terrain.
All right. I’m going to come back to you in a minute because you have such an overview, and you’re also an Associate Professor at Tufts. And so, you study all this, and you’ve written books. But I want to introduce the third guest. And that is a leader from the pharmaceutical industry and one of our most respected and venerable companies in the field, and this is Merck. So, joining us in a senior vice president of clinical operations there around the world. And that’s Andy Lee. Andy, welcome. Thank you so much for being with us.
Andrew, thank you. And pleasure to be with some prestigious panelists, both of whom I know. And I’ve met you over the last two weeks. And thank you to T.J. and yourself who have been trial participants and who are representing that part of the organization.
Okay, and we should mention that both T.J. and Andy are working on a couple of levels. And Ken sounds off on this too. There is a group called TransCelerate where pharmaceutical industry is working together on some of the issues they face in having the proliferation of trials. More trials sites, more accessibility, procedures for that. And then, of course, Andy has helped lead that effort at Merck related to breakthrough therapies that they have been trying to develop there in supporting patients who might be in Merck trials. So, we are going to come back to that. But I want to go to you for a second, Ken. Ken, how low is the participation among adults in clinical trials, at least in the U.S. Now, I’ve heard really low percentages. Where are we now with that?
Right, it’s a great myth for us to start with, this notion that only three to five percent of patients—eligible patients, participate in clinical research. That’s actually a statistic that was published by the National Cancer Institute in the early 1990’s. The latest research really shows that it varies widely. For example, when we look at pediatric cancers, the participation rates are extremely high, 80 to 90 percent in same cases—pediatric leukemia. In part because those communities have very engaged healthcare providers, very engaged families that really share their information. It’s just an enabled community where all of the stakeholders support participation. And then there are other areas of course. Some cancers where we do see relatively low participation rates. But I want to point out that low participation is driven by so many factors, Andy, including the strict eligibility criteria. And the demanding protocol designs which are a real burden for some people, and they choose not to participate. As well as low awareness, very low accessibility to trials among minorities and underserved communities. So, there are many factors that contribute to this variation in the participation rates.
Yeah, you’ve ticked off some now. T.J., in your own experience, one of the breakthrough trials you were in you had to go from Ft. Lauderdale in South Florida and move your whole family to Tampa in central Florida, right. I mean that was a big deal.
Absolutely. When you have a young family and a stage four cancer diagnosis, relocating simply across the state during the holidays especially, is no big deal. We were fortunate because we had the means to be able to move there with work situation, with family. But too many people can barely go across the county, much less the state or the country to find a trial that might be the best match for them.
Andy, so we’ve ticked off some of the obstacles, and Ken touched on some about even the proliferation of trials. Is that a lot of what you do is how can we have trials be more accessible, be more widely distributed to a clinic near you?
Yes, let me just explain. When we look at a new cancer therapy, we look at the various cancers that may be affected. And what we do is we go for high probabilities of success. And the challenge is if you bring a new cancer agent. You normally start off in very advanced disease. So, patients would have failed multiple lines of therapy, and often it is a last gasp. And you have to show some sort of clinical efficacy. And then you move sort of backwards in the disease, and you go from sort of third-plus line, second line and first line.
And then you may work downwards into earlier stages of the disease into an adjuvant setting and maybe a neoadjuvant setting. So, as we sit down and design a trial, what we need to look at is what is the population that is most likely to show any benefit at all. And quite often when you are developing a new therapy, it’s difficult to show benefit because many of the patients are very ill. So, what we have to do is optimize the opportunity for success of a compound by going to the right target patients.
And quite often as we have learned a lot more about cancer, this does not mean we test a product broadly in anyone with cancer. We typically try and find a profile of a patient that is likely to respond. And many patients now will realize their predictor biomarkers or prognostic biomarkers. So, for example, with immunotherapies, those that work through the PD1 mechanism would probably want to have a PD1 ligand receptor positive patient who is likely to bind to the drug.
And that gives a higher probability of success. So, it sounds counterintuitive that while we want to develop therapies for all cancer patients, when we start clinical trial development, we have to show efficacy in a population that will benefit. And that’s normally predefined and makes the inclusion criteria fairly strict. As we show efficacy and as we can move into broader populations, it makes it a lot easier for us to design more liberal clinical trials. And then we can actually spread those in the geographic domains.
I could talk more about geographic allocation, but let’s hold that for the time being, and let’s see if there’s time later on.
Can I just add to what Andy said because I think it’s really important for your viewers to understand just how active drug development activity is today. We’re looking at over 4,000 pharmaceutical and biotechnology companies, some of them very, very small. But in total, we’re looking at nearly 6,000 drugs that are in active clinical trials. And to Andy’s point, many are really targeting a patient with a very specific genetic profile or a specific biomarker. But it should give anyone who believes that a clinical trial may be an important care option for them, they should recognize that there may be many, many trials out there.
In total we estimate as many as 80,000 clinical trials, nearly 50 just conducted in the U.S. alone—50,000. So, it’s just important that we keep all this activity in perspective.
Right. So, T.J., that’s why all of us as patients need to ask about them, right? Go to different resources, whether it’s an advocacy group that you ultimately spoke with other patients, and obviously quizzing the doctors we go to. Is there something that may line up with my situation, right T.J.?
Absolutely. There is a both top down and bottom up approach here that patients as they become educated—and every patient should be the owner of their healthcare as they become educated. Hopefully they are coming across advocacy organizations, other informed patients, patient support groups—all of which will help inform them different options for disease treatment, including hopefully as Ken mentioned, clinical research as a care option. At the same time, there is certainly very much an opportunity from the top down from the sponsors who develop the trials and from the sites that execute them to educate patients as they come in.
Not just at their own site, but at any site, at any medical facility. That if you have a diagnosis and you are looking into your care options, that you should be asking the question. And we should be giving you more information on the possibility of clinical trials and where you may find clinical trials that are appropriate for you.
Right, the whole enchilada, if you will, of all your options. Andy, so you mentioned about trial requirements. So, first of all, what efforts either at Merck or are you aware in the industry are being made to really talk to patients early on as you are designing trials? Whether it’s the requirements—how many CT scans you’re going to have. How often you are going to have to go to the main trial site. All the different things that sometimes get in the way.
Well, firstly we start with design. And we believe in exquisite trial design, quality by design as well. So, what we want is to run the experiment once and not have a sloppy trial design. We want to make it really robust in terms of scientific integrity and operational execution. So, we have a lot of internal design committees and what we do is we co-op with many groups external to our company. So, we speak to people who run clinical trials at cancer institutes.
We speak to the doctors who manage this. We speak to the trial coordinators. We speak to people involved with the transporting and shipping of medicine how they would do that. And then we of course speak to people in the ecosystem. We quite often speak to investigational review boards before we start trials. We talk to them about our design and what would be best to protect the rights and well-being of patients. And then, of course, the patient-centric approach says that we need patient insights.
And I’ve chosen my words very carefully because the insights are really important. Not all patients—and I’m very respectful that some patients are very intelligent and actually may be involved in this. Some patients can contribute to design, not all can. And so, what we do is we take the insights and we impute those. We often have focus groups. We talk about this disease. We talk about the burden of the disease. And then we talk about how that disease is managed in an ecosystem. And quite often in different countries it’s managed differently.
And so, we have to appreciate the global clinical trials have to navigate a path that may not be a linear path as we’d see it at an exquisite elite cancer center in the United States. It’s community-based, it’s all the rest. So, we take that input, and what we try to do is unburden the trial for the patient. We say, “How can we design a trial that requires the least visits to the clinic—the hospital, the least burden for them. And how can we take some of that burden from the clinic and actually transfer that into an easier environment.
So, document reading and review. Perhaps filling in questionnaires about quality of life. These are things that don’t have to be done in the clinic itself. And then often when we work with clinics, we work with them to help them understand how we as sponsors can make their life easier. And some of those things might be simplifying the informed consent. But I want to stress just one point here is that we can do whatever we like in the design at a company.
One of the things is, the patients are not sponsor patients. Okay, we sponsor clinical trials. The patients are managed by a doctor and a professional. And underneath that principal investigator is a whole oncology team. And it involves radiology. It involves pharmacists. It revolves around a 360 multidisciplinary team. They’re exquisite. They help manage the patient, not the sponsor. We provide the enabling functions for them. And then also that the oversight of the patient’s right, safety and wellbeing is the responsibility of an institutional review board.
And while we may provide templates and simplify templates in text and language, we rely heavily on the institutional review boards to help us with things that may make things easier, such as reimbursement for parking, transport, all of these things. And by and large, the institutional review boards are very supportive of these things. But they are very difficult to quantify in exact terms because of different geographic regions and different norms in different places. So, we rely heavily on exquisitely well-trained 360 team who manages oncology patients with a great PI. They manage patients.
And we work collaboratively with the sites who work with patients on our behalf. So, I just wanted to say the myth is that sponsors interactive with patients. That’s a myth. And the truth is that we engage with clinical sites, and we try and make our design and all the elements—the enabling elements, simpler for the trial sites in order to manage the patients in a simpler way.
Okay. Thank you for that. So, Ken, I want your comment on that. Because okay, we are downstream patients. We have a doctor, healthcare team. And we know somewhere in the background there’s a sponsor that tried to enable good things to happen to get reliable data and hopefully a cure for us. So, how do we—what’s happening? Are we improving things there in that interaction between clinic and patient?
Yes, we absolutely are. And I’ll start by just echoing and acknowledging that Andy has really laid out just an incredible amount of input that goes into the design of a protocol. And that’s really for a really large company. We see many, many examples now of patient advocacy groups or smaller companies turning to a variety of approaches to solicit input from patients and healthcare providers. Some virtual approaches through a social media or digital community. So, there’s lots of ways that feedback is being channeled.
And that’s really important. The flip side, to really answer your question, is that our protocol designs are becoming more and more complex, more and more demanding. A much larger proportion of drugs are now targeting rare diseases that have been stricter inclusion and exclusion criteria. And the designs of the studies—the number of procedures and the number of visits. The number of investigators that are involved, all of that has also continued to grow. And as a result, we do see that our trials are taking longer.
We have yet to see a year when we actually witnessed a reduction in the cycle time to conduct a clinical trial. And we just have to figure out new ways of making the participation process less burdensome and more efficient.
Oh, my. So, T.J., you had been living with stage four melanoma, a life-threatening condition. We have people even on our team who are living with stage four disease. So, when Ken talks about things slowing, that’s not what we want to hear. We want to hear two things. One is, we can accelerate a development of new medicine. And ideally—because this is an issue certainly in the U.S., but I think worldwide, that by speeding the process, cutting through red tape, improving procedures and us participating, the cost can be less as well.
And when we talk about cancer, the costs are going through the roof as you know for people living with chronic cancer. And you know so well, Andy, people who are on some of the medicines that you’ve come out with at Merck. Where people used to die unfortunately in short order, are living a much longer life thanks to new medicines. We want it to happen faster and be financially achievable. Andy, any comment about the pace of science?
Yeah, I would like to make a couple of comments about that. We often hear the sort of story that 80 percent of clinical trials don’t recruit on time, et cetera. We do immense feasibility. Once we have designed a protocol, we send it out to all of the countries that could potentially work with us. We have staff in 47 countries. And they look at two areas of interest. One is the medical durability, is the comparator the one we use in our country. Is the protocol designed the way we practice clinical medicine, not clinical research medicine?
And will that enable us to recruit the patients? That’s the first level. The second level we look at is to ask the question, is this operationally feasible? Can we source the comparator? Do the clinical sites have the equipment? How would we have to ship the biological samples around the world? And based on medical durability and the operational durability, we do a site selection. And we run the indicators through a Monte Carlo simulation. And we simulate this trial. What if we took three countries out? What if we added this more sites? What if we changed this inclusion?
And we come up with a model of what the recruitment would look like. And recruit about 80 percent of our trials according to our model. So, about 80 percent of our trials recruit on our model time. And then if we look at the typical time for drug development, it has been from eight to 10 years for many years in the industry. And when we look at some of the development timelines now—the cycle times. Pembrolizumab (Keytruda), for example, from first study until first approval, was 60 percent reduction in time.
We were looking in the four-year time period. And we are looking at five or six years for many indications. And so, we’ve halved that cycle time for some of the newer oncology products. And there are a number of reasons we’ve done that. One is we have found operational efficiencies. Two is the trial design has enabled us to interim analysis with independent data monitoring committees to assist with that. I’d also like to put in a positive plug for the regulators.
I do believe—and I’ll talk specifically about the FDA, because they are the agency for the United States. They have revolutionized the way they approach the designs and the way they review the data. And they have breakthrough designation status they’ll give to compounds that are really looking like they have strong efficacy. And so, the approval process through the agency has improved remarkably. And they’re open to adaptive designs. And they are open to interim analysis. And they are open to all sorts of things.
So, I really wanted to give credit to our agency who has said, “Where there’s a need for breakthrough medications, we’ll try to find the path.” And so, I do believe there’s a real positive side to this. The challenge is the market is saturated. We have now more than 25 PD1s in development. And to put the 25th one in there, they are so far behind in development. I wonder what that does. It clogs up the system. So, when you look at how can we influence sites, at the top sites we only get one or two patients.
And we compete with 50, 60, 70, 80 other sponsors. And so, it becomes so saturated that, that site has to learn to do systems and process with 70 companies. And what they are doing is almost hedging. They are not focusing on certain things. So, in those cancer centers, they offer treatment for all lines of therapy and all types of cancer, the specialized and nonspecialized. And we are moving out of that sort of geography and moving it community-based oncology practices where it’s less saturated, and we can actually have more traction there and be able to engage more with the clinical trial enterprise for the good of the patients.
Ken, you write books about all kinds of issues around this. So, if we are getting—particularly in oncology to have trials offered at the community practice where those doctors work night and day—the nurses. They are really stretched. More and more cancers, genomic subtypes, most sophisticated testing. How—what would you say the patient can do. T.J. talked about it a little bit. What would you recommend to patients so that at that community oncology practice the patient and the family can kind of discover what may be available for them as Merck and other companies try to get these trials distributed?
Right, well you—talk about the whole enchilada, Andrew. You’re really touching on it. It’s also very exciting times for patients, not just cancer patients, but patients that are dealing with any chronic and severe illness today. And it’s really all about more of a partnership with the clinical care environment and clinical research. And of course, at the heart of it is the patients and their family being as informed as possible, sharing their electronic health and medical information so that they can be connected to trials that might be appropriate for them.
But it’s moving—as Andy said, away from the classic places where trials used to be conducted. And in many cases, they were at these dedicated centers that only conducted clinical trials. It’s a very competitive environment now for patients. So, many sponsor companies like Merck and others are looking at clinical care settings and moving into communities or, in some cases, large health systems where you can have clinical research professionals who will supplement and provide support to the healthcare providers, so they’re not stretched too thin.
But so that they have the clinical research capability onsite at the point of care. For patients it’s a great opportunity because now they have the opportunity to get their own healthcare or treating physician and treating nurse involved in a clinical trial as part of their overall care. And we expect to see more of that over time. We expect to see other virtual trials or opportunities for patients to participate in the comfort of their own home tied in with their clinical care setting.
And all of this is relatively new to the whole world of clinical trials and the investigation of experimental medications.
You touched on something I just want to follow up on. I’ve heard of this term site-less trials where you said you participate in your home. So, T.J. had to go from Ft. Lauderdale to Tampa. I had to go from Seattle to Houston. There are not—this is a big deal, especially if you have little kids as I did, he has. So—and away from work and whatever your situation is. So, is technology going to come in play so Andy can get the data he needs for the FDA, but that we can have technology help accrue that data in a more efficient way.
And I’ll say absolutely. And my colleagues here today I’m sure can comment on this as well. But absolutely. We are seeing wearable technologies and mobile applications that now have the ability measure vital signs and other important baseline information in a validated manner. There are ways that you can access a specific facility for a highly specialized test, specialized imaging for example where the technician can evaluate it remotely. Blood can be drawn at remote locations as well.
So, there are lots of places where we have sort of this more flexible environment that can cater more to the patients and less about a specific physical facility where you have to go to participate in a trial.
T.J., I want to talk to you about diversity. So, you and I are kind of middle-class white guys. But we want to know how new medicines work for a variety of populations, ethnically, economic groups, et cetera. And Andy needs that data. And he goes to the FDA, and the FDA says, “Well, do you have Hispanic people? Do you have Asian people? Do you have African American people?” or whatever the country is because he works globally. And they say, “We want to understand are there differences?”
How are we doing with that. How can we make a difference there so that we really know what medicines make a difference for broader and also distinct populations?
I’m sure Ken can back up some of these things with more hard data than I can. I know that different populations have different levels of trust with the medical system. One thing that you and I both experienced was a lack of options—a lack of good options. And when you get into dire straits, you tend to be a little more trustful of anything that comes along. But we have serious or chronic conditions that have proven treatments that might not be the most effective for certain populations.
And we’re not able to broad the scope to these minority populations or populations that don’t have access to NCI designated cancer centers or top-notch medical facilities. They are not able to get either in a trial that is looking for a drug that would help them or even get access to medicines that have been recently approved simply because their healthcare situation doesn’t allow it. Whether that’s a lack of insurance, a lack of healthcare literacy or simply a mistrust of—there’s a lot of generational mistrust I think in some communities of the clinical trial system.
So, as an advocate, I certainly push caretakers especially—and children caregivers for older populations who are maybe first or second-generation Americans to help facilitate a conversation between the medical professional who’s trusted and a patient that might not be able to get or rely on the information they’re given. Because it really will speak to populations that don’t get the opportunities that you and I have gotten simply because they are either not aware, or there is a barrier there to get to that medical professional.
I appreciate, T.J., you mentioned CISCRP. That’s one of the things that we’ve focused on for 18 years is bringing clinical research education into major metropolitan areas around the U.S. and parts of northern and western Europe where we plan for several months, and then we put on what we call an Aware for All events. And we really work very hard to encourage participation by—or from patients based within minority or underserved communities.
And I’m happy to say that we’ve had a lot of success with that. These are really difficult communities to reach through a lot of the traditional approaches. We have to rely on community centers and clergy and other approaches to really help these communities, for a lot of the reasons T.J. mentioned, trust the educational information, and come out to learn more. And I’m happy to say we’re seeing more and more people of diverse backgrounds that are curious and interested in learning more about clinical research, especially knowing that representative populations provide more information that can inform treatment for different types of patient sub-populations.
I want to go to Andy in a second. Andy, just one second. I wanted to mention and call out—and Andy’s company has been a leader in this. He was talking about PD1 and all of that. But drugs that have been breakthrough in immunotherapy for people like T.J. where—and it’s being explored in broader cancers where otherwise life was going to be short. And how to activate the immune system and really fight the cancer in people living long term. So, the people in those trials—and certainly there were people in the melanoma trials like yourself T.J.
Lung cancer trials and increasingly now others who did get tomorrow’s medicine today. Andy talked about accelerated approval which is great. So, that’s the impetus for the patient and the family. Is there the chance to get tomorrow’s medicine today? Now the obstacles may be distrust. You talked about that, Ken. And also, is maybe accessibility. Is it as a clinic near you? And Andy you talked about pushing that out. And then sometimes it’s related to cost.
Now is there anything that sponsors can do, Andy, related to the costs that people may have in being in certain trials? Where do we stand with that?
Yeah, so I’ll just touch on the distribution first and then get into the costs because they are linked. When we prosecute global trials—we’ve had a very U.S.-centric discussion so far. But cancers present differently in different geographic regions of the world. And so, when we want speed out of our trials. You want me to shorten that timeline and get drugs to market quickly. I do it internationally and in some cancers like esophageal cancer or some of the gastrointestinal cancers, Asia has a much higher prevalence of these cancers.
And we do a greater proportion of work there. We always include multi-country studies. And U.S. may have a greater proportion in other areas. So, we balance that out to optimize speed. Of course, with clinical trials the cost structure around the globe is very different. But let’s talk about U.S. We have spoken about a saturated core of clinical trial sites that we all go to. And I speak generally now for all sponsors. And we are all looking to optimize and get great efficiency.
At the same time, we realize we have many underrepresented geographies and ethnic groups—and not just ethnic groups, but under resourced populations. And so, what we’ve been thinking about is how can we support people, and support people at all levels. And so, we start off with thinking about the cost structure, and we obviously pay clinical sites for what they do. But we will support all sorts of things. We’ve been negotiating with Uber and Lyft, so we can build that into automated transport for patients.
Again, the IRB has to approve that. We are looking at ways to augment that they are not out-of-pocket for things. And we’ve been talking a lot with a group called Lazarex Foundation who has really expanded into under resourced communities and found ways to ensure that they have daycare and different access for those patients. We have worked extensively now to look at outreach programs into communities that typically wouldn’t be in trials. We are focusing in two areas right now as we speak.
One is next generation of HIV medicines, and the other one is in prostate cancer. And we’ve got a large program rolling out in prostate cancer. So, what we are doing is going into sites and we have put together training videos and training materials. And we are looking at cultural competency. So, it starts at the site. Are they culturally competent to engage a different community? And we’ve spoken about working with the community churches, community education systems.
And so that starts with cultural competency. I have a woman, Madelyn Goday, who works on this day and night in my organization. And she’s very strong at this. It’s early days, but if we can show that it works in one or two therapeutic areas and cancer types, we’d expand it further and further. But we can’t just have a shotgun approach and just go and do 100 sites and hope it works. Hope isn’t a good strategy. We are working systematically to engage different people. And as appropriate and approved by ethics committees, we will support all of these communities and help build infrastructure and capacity.
Those are important things for us. But as I said, where appropriate and where it’s sustainable. We can’t just throw money at something in the hopes something sticks. We have to have something sustainable and it goes to what Ken says, and that’s education and providing resources and materials. And we’ve used quite a lot of Ken’s materials in multiple clinical trials. Thank you for that, Ken. It’s been really helpful for us.
Great. I wanted to note for your audience. If you have a question, send it to firstname.lastname@example.org. We have expert panelists here. And this is really—we are all in this together. I think you hear the dedication from Andy at Merck and T.J. as a patient advocate and Ken as a professor and founder of organizations devoted to this. We want obviously accelerate medicines, but have the accurate data of how it affects different people, who is it right for so that the regulators—and thank you for what you said about the FDA here in the U.S., has the information to make a decision on should this medicine be available for people with that diagnosis.
Okay, so what about staying in the trial. So, T.J., how long—let’s take with the Keytruda trial or one of them. How long were you in to for?
Nearly four years. Three-and-a-half years.
Were there ever times when you said, “I’m done. I want to bail out.” You know.
I’ll be very careful how I answer this question for Andy’s sake.
It’s okay, T.J., we’re friends.
No, probably the biggest crossroads I ever came to was when one of my tumors started growing about a year into it. And we weren’t sure if the medicine stopped working or not. We didn’t know what to do. And as it turned out, it was still working. And I think was just one spot that wasn’t responding. But everything else had responded great. However, at the point, as a patient, you’re thinking about yourself first and your family first and the trial second. It’s easy to stay compliant on a trial when things are going well.
But when you’re ahead of the medicine in some ways, and I think patients with chronic illnesses or in some cases rare diseases, are almost more knowledgeable than some of their doctors or the trial protocols about when they’re stopping. They don’t have the luxury of finishing out a protocol and seeing where their disease journey takes them. And the best example I can give of this is a very passionate advocate by the name of Jack Wheelen who we unfortunately lost a couple of years ago, but whose influence has kind of dominated the patient advocacy world for the last decade or so.
And Jack was able to monitor his health almost better than a doctor. And he knew when his trials weren’t working. When we get to that point in a clinical trial setting where we know the medicine is not being effective or where a patient would be better served to move on to another treatment. That’s when we are going to take the next step in clinical research, because now we’re aligning the trial design and the trial goals with a patient and a patient’s family’s treatment goals. And as those two points merge, that’s where clinical research becomes that much more effective as a care option.
That was well said. And I think with all those trials, you’re right, the team—that care team, what’s right for you at that time. Obviously to get the data, but also not at all costs. In other words, if the data is showing something is no longer effective for you, is there another treatment or a trial? I’ll just share my story for a second. So, I was in a phase two trial of combination therapies—which are increasingly common certainly in oncology. And after three months—halfway in the trial, my blood was kind of cleaned up.
And I had nausea and some other side effects. And I said to the trial coordinator, “You know, I think I’d like to stop.” And she said, “You know, our belief is that you still have microscopic illness in your bone marrow—in this case with the blood cancer, and the additional three months in this protocol will make a long-term difference for you. That’s what we believe.” They didn’t have the answer, but that’s what they believed. You know what? I stuck it out. She was right. I had 17-year remission.
If I’d stopped after three months, would I have? So, it’s a dialogue with the care team Andy, right? It’s this ongoing discussion not just entering the trial, but remaining in the trial, correct?
Yes. Absolutely. And I just wanted to impress a really important thing. People talk about people dropping out of trials. In cancer trials we see extremely low drop out. I mean these are potentially lifesaving medicines for all of the companies. But what we do want to make sure about is that when there is progression of disease, and it’s shown that the drug—whichever it is, the control arm or the active arm or the new agent, where there is progression of disease that they get the best available therapy.
And so that often contaminates trials because we have the crossover effect that now they are getting maybe the experimental agent in the standard of care type of thing. But most important thing for us is to track the survival of the patient, regardless of whether they go on another therapy. And we have put a tremendous amount of effort into looking at the informed consent and making sure we work with IRB to track patients long term survival.
Because as you’ve said, you may have a short-term issue that shows that the drug may not be working short term, but long term it may have prolonged and profound effects. Positive or negative, we don’t know that. And so, what we like to do is get long term survival. And we ask patients to consider when they sign the consent for whatever trial and whichever sponsor is sponsoring this, is to consider that knowing their status throughout their treatment—whether it’s on a sponsor’s drug or another sponsor’s drug or x therapy. It is really important — and I ask people to think about that.
Because that really helps us get as much data out of the individual treatment as possible. And that may prevent nonrequired trials in the future or it may say, “Wow, that really informed.” And we’d like to inform all cancer patients. If data we generate can inform other therapies, we certainly want to do that. We do not want to do wasteful clinical trials. So, tracking patients long term or patients—the message to patients is being cognizant of letting the sponsor—and the sponsor could be an institution. Letting them know your status is really important. All they want to know is are you dead or alive.
In the end, just one thing is, are we partners. In the end, our viewers here, are we your partner? And can we feel that not just for their doctor but you guys behind the scenes with the labs and everything, that in the end we are partners. And unless we see it that way, we won’t get anywhere.
Absolutely. I’m glad you used the term partners. Because when we’ve done a prep for this people have said, “Are they investors in the thing?” So, yes, patients invest their time and everything, but they are partners in research. They are contributing so much. They are contributing—they are going into the absolute unknown. And there is an immense trust level that is there. And we owe that back as research professionals is to treat people with respect, dignity and as partners, to make information available, to publish our data to get it out there as quickly as possible. And to make sure we get that back into the participant’s sort of hands.
So, Ken, how are we doing on that because you go back over the years and people say, “I don’t want to be in a trial because I’ll be a guinea pig,” and respect was not seen as part of it.
Well, that’s also a bit of a myth, right? You had a few that claimed that they felt the process made them feel like a guinea pig. The vast majority of people, over 90% of people who participate in a trial, would do it again. So, once they get past that unfamiliar area where they’ve perhaps only heard a few case examples or a few very vocal people who had bad experiences. Once they’ve done it themselves or they’ve been able to work with a group of advocates that really help them think about this process, and they become more educated, generally they’re very impressed with the level of professionalism, the compassion that exists at all levels.
I work with so many professionals—science professionals and pharmaceutical companies and at the research centers, and they all share that kind of commitment that Andy just mentioned. There’s a real desire to partner with the patient to really inform them. I would say one place where we need to see much, much more however is in the return of clinical trial results in a plain language to people who’ve been in trials. That’s a place where as an enterprise—government, research sponsors as well as industry have not really made this a standard practice at this point. And that’s one thing that we’re really working on actively.
Right. Great. So, T.J., you and I are investors—and Ken used that term and Andy used it, and I’ve always believed it. We are investors of our tissue, our body, our future to help other people and hopefully help ourselves. And certainly, for profit companies that may greatly benefit if they have a blockbuster therapy. But we need to be kept informed in the long term, right T.J.? We want to know what a difference our participation made.
Certainly. And I think to echo what both Andy and Ken said is that patients do become partners. Patients who are involved in clinical research, a significant chunk become altruistically invested. I’ve heard more than once, “Even if this doesn’t help me, I’m glad I participated because it might help somebody else.” I know I’ve felt like that, and I’d venture that you’ve had some of that too, Andrew on your journey. So, it’s only—it’s at the very minimal fair, and it’s certainly very justified to expect as a co-participant in this.
And as kind of a co-creator of science with sites and sponsors that we understand what has come of our sacrifice and our time dedication to helping science out. We shouldn’t have to find it out through press releases from ASCO or hope that we hear about it on the nightly news. We deserve to hear what has happened. Not just because it can affect us as people and as patients, but that we put a lot into this too. And then we did our part to further medical research and we want to be part of the—whatever the end of the trial ends up being. We want to be aware of that. Not just for personal knowledge, but to know that it’s going to help this many other people.
Right, to be honored. So, Andy, at Merck you’ve established some internet platforms in particular related to keeping people informed, right?
Well, we’ve got an internet platform that people can log onto. I’m happy to share that with you; in which they can get access to a list of our trials. So, I didn’t prepare this but especially, but I did make a handmade note. And if anyone wants, it’s a very simple log on. Andrew Schorr:
You’re a great artist.
And it’s a simple one. What that will get you access to is two main important things. One is it gives access to information about clinical trials. We have a tab on there that tells everyone about the phases of clinical trials and what to expect in a trial. So, it’s an educational part. Then we have a lot of information about the Keytruda clinical trials were, are running, and they’re called keynote trials. And there you can look at the different indications. And you can look up and it has a telephone number you can call.
Now I must stress is that we run over 1,000 clinical trials in oncology. But many of them are not sponsored by us, they are investigator sponsored trials. So, you can go to clinics, and they run their own clinical trials that are not sponsor-related. And the NCI runs their clinical trials. So, there are a lot of different sources. And many companies will have clinical trials. We also have the website clinicaltrials.gov. I’ve had to use that in the last two days for a colleague.
And you can navigate that and look for different types of trials. And you can look at different products and everything. It’s not perfect. But at least it’s a place to go to. And I don’t want to sound as if I’m one sponsor centric. Many other companies have access to websites, and they really want to try and enhance and direct people to the clinical trials sites at which they are working.
Right, absolutely. And then you were working at the industry level with a group called TransCelerate, and I know T.J. is involved too, to try and establish common procedures as you establish trial sites, as you have communication, as you have training, right? So, that hopefully all boats will rise, right?
That’s correct. TransCelerate is a group that formed about eight or nine years ago. There were 10 initial member companies. I was a founder member of that. And we got together to say, “We have to improve operational efficiency.” So, we do not collaborate on molecular structures and those types—that’s competitive. We collaborate on what we call precompetitive, procompetitive aspects which says, “If we all work together to improve something, we’ll all get the benefit of this.” And we share it publicly.
There’s a website, you can look at it. But we’ve looked at standardizing protocols. We have a common protocol template. We’ve adopted that at our companies, so have other sponsors. The protocol can be developed in a standardized way. We’ve looked at standardizing ways where we can improve monitoring. We’re looking now at ways that we can work with investigative sites through i-platforms, shared investigative platforms. So, a clinical trial site has to provide the information for us as a sponsor and use the exact same standardized questionnaire and information for any other sponsor through a standard portal.
So, we are trying to reduce the burden on clinical trial sites. And we’ve plugged away for many years, and we are seeing greater traction there. We are seeing more efficiency, more standardization. We are seeing greater quality, less rework. And so, while it’s hard to quantify this, what we believe is that the sites are freed up of some of the more burdensome things, and they can direct their attention towards patients, patient safety, and access to clinical trials. So, the work may not be directly related to access for a cancer patient into a cancer trial, but there’s a lot of tangential spin-off of making a site more efficient so they can put their resources and energy in the right place.
Well, thank you for that effort and your leadership. So, Ken, you’ve been around this a long time. And you’ve deal with all the companies and the government and the various agencies. And as you know, in some quarters there’s a distrust for pharma. We mentioned cancer that you get the price tag of a drug, and it’s very expensive. And some people are struggling to pay for it. And there’s just frustration about it. And often in the news media they are the bad guys who are called out for unethical procedure or something that went awry.
So, how are we doing there in overcoming that because we talk to Andy, he seems very ethical, dedicated guy representing a company that’s been around I think well over 100 years. So, how are we doing to move clinical trials on in this area when people aren’t sure what to make of pharma.
Yeah. It’s a huge issue, Andrew. And I think part of the challenge is that all it takes is one questionable behavior, and it makes it difficult for the reputation of the entire industry. Right now, we are dealing with major pharma companies that are actually being fined for having contributed—a judgement, having contributed to the opioid crisis. And when you start looking at some companies aggressive marketing tactics, right? It really sort of sheds a darker light on a lot of the great work that companies do.
What we look at, at the Tufts Center for the Study of Drug Development at the School of Medicine. We look at the overall output, the level of innovation that’s coming from the industry today. And we look at the number of complaints that have been filed with the FDA and other regulatory agencies around the world. And what we see is tremendous growth in the innovation and the quality of the innovation—drugs like Keytruda and other cancer immunotherapies. What an exciting area.
We see that the vast majority of companies really support and live by highly ethical, highly professional, highly compassionate approaches because they all know that it takes just one questionable issue that can really tarnish the reputation of every company operating in the industry. So—again, Andy also mentioned just how regulated we are as an industry, the fact that we have ethical review committees and data safety monitoring boards and so many other external agencies that help to oversee the work that’s done here.
So, I would say for patients who are thinking about clinical trials, it’s good to know the history. It’s good to know what you need to do to protect yourself. But the vast majority find that the people they deal with are ethical, they are professional, they are compassionate. And, as I mentioned, over 90% of people who get involved in trials say that they would do it again.
Thank you. That was a wonderful response. Andy, you mentioned earlier about starting research with the sickest people basically, where there are no options. But one of the questions that came in is, “Are trials only for the sickest people or are there of all those trials you talked about opportunities for people who maybe are newly diagnosed or could be their fairly initial therapy?
Yeah, great question. And thank you to the person who asked that. And the answer is that we start in people—because we don’t know if our experimental agent will work. And everyone assumes that new medicines are all going to succeed. And we work in research and researcher because of that many things fail very early on. They fail in phase one before anyone hears of it. It’s normally a code number at that point. And we may just not make the drug soluble enough, or it may not be distributed enough.
So, we may have a thing that works in a test tube or a petri dish. But to get that into humans and make sure that it’s safe at the dosage we use often fails. We just don’t progress far enough. So, what we want to make sure of is that firstly the drugs are safe. And there’s a trade-off between safety and efficacy. We’re constantly trading off. And so, what we do is we look at that and say when someone has no option and we want to get an option going, that’s where we start.
We’ve actually moved down the disease scale, and we’ve come into adjuvant treatment or secondary prevention. And we’ve gone into newer adjuvant is when you have a small tumor is we pre-treat to manage that tumor before surgery is done. And post-surgery we hope that there’s limited treatment or no treatment. And we actually have removed the cancer, and there would be no evidence of disease. But. of course, using the word cured is something we try not to do, because we prefer to use no evidence of disease.
But absolutely. And the next strategy is prevention of cancer. Our company does a lot of vaccinations in women’s health. We have a product that protects against human papilloma virus which is a precursor for cervical cancer. So, people who are vaccinated with this particular product—and I’m deliberately not using brand names for obvious reasons. But when you vaccinate for HPV, you essentially are preventing the likelihood of a cervical cancer. And there are now prospects in many disease areas where either vaccination or early treatment gives you a tremendous positive prognosis of not getting the disease later on in life.
The answer to your question is yes, we are absolutely looking at ways to prevent getting to a very advanced stage which is very costly to manage and very emotional and stressful and difficult.
I want to thank you. I just want to get a final comment on what you would say to patients or family member. And I want to start with you, Ken. What do you want patients right now to know so that—what tips would you give them so that they’d consider being part of clinical research or stay in clinical research and the benefit it could be for them.
I will say really two things. The first is there’s just a tremendous amount of information out there, and we recommend education before participation. So, do your homework and engage family and friends and people you meet and trust to help you make the decision. And the second point comes off of that. And that is this is not a decision you make alone. Really bring in your treating physician, your nurse. Bring in your support network. And chances are you will learn a lot, and you might even find a trial that is right for you.
Right. And Andy, what about you? A final point—what would you say to a friend or family member or colleague related to considering trials today.
We get this question every single day. And we get it from patients in need. And my answer is we are all patients. We are all going to face this as professionals in our job or professionals outside. And so, I say community of practice. And disease hits all of levels of society in all education professions, et cetera. And so, my thing is to encourage people to do what Ken has said. Work as a team. Get multiple inputs.
And I am sponsor agnostic. Get the best therapy that is available. And that may be the best care option—as I said, the ecosystem in which you get the care is really important as well as the medicines that you get. So, have the discussion. Trust the medical professionals, they are very skilled out there. They are extremely well educated. And I just urge people, “Don’t think on two clicks on Google you are going to solve what your treatment option is.” Really discuss it with people because not all the options are public, and there is not enough information available about how to manage the whole disease through the entire enterprise. Trust the professionals.
Well said. And T.J., you and I are alive today because of trials. What do you want—what’s the thing you want to leave our viewers with?
That they don’t have to be involved in clinical research. I think that’s an important distinction to make. And it’s going to pull together what Andy and Ken said that clinical research should not be considered a hail mary or last gasp option. If you are a patient—and we are all going to be patients as Andy mentioned. You want the best care for you. You want to be able to weigh all of your options. And if you are not considering clinical research, if you don’t know about it or aren’t able to get the information you need about it, then you are not going to be able to make the best healthcare decision long term for your health.
So, take that information that you can get. Find the trusted sources. Be able to reach out to advocates or colleagues or someone that you know that would have the disease or can connect you with good information. And be your own advocate—a little cliché, but really own that healthcare information. And once you are able to collect all of the different treatment options, then you consult with your professional medical team as to what the plan forward—the best plan forward for your individual situation would be.
Right. T.J., my friend, thank you. It’s a delight to see you again. Andy, with Merck, thank you so much for being with us and bringing your years of expertise. And, Ken, being at an independent non-profit center and also at Tufts University there, thank you for all the work you do. I want to thank the Patient Empowerment Network for pulling this all together. And the sponsors who supported us in this effort, AbbVie Inc., Celgene Corporation. Daiichi Sankyo and Novartis.
All these companies and I’m sure many more, working so that research can move forward. We can be true partners in it. And hopefully get tomorrow’s medicine today to make a difference for the community and live a long life, and hopefully a cure, right? I’m Andrew Schorr in California. Remember, knowledge can be the best medicine of all.
Please remember the opinions expressed on Patient Empowerment Network (PEN) are not necessarily the views of our sponsors, contributors, partners or PEN. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.
https://powerfulpatients.org/pen/wp-content/uploads/CT-Myths-1.png600600Kara Rayburnhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngKara Rayburn2019-09-17 10:30:152019-09-17 10:30:15Is It Difficult to Participate in a Clinical Trial?
Dr. Altman, let’s talk a little bit right now about treatments that are currently available for AML. What kinds of things might patients want to familiarize themselves with?
Dr. Jessica Altman:
So, we are at a point in AML therapy where there’s not just one choice of treatment.
There are a number of choices that depend on patient characteristics, disease characteristics, and patient goals. So, there’s a lot that the physician with their patient and family members take into account and consider when they’re coming up with a therapeutic strategy.
So, give us a couple of examples. Chemotherapy is one way to treat AML, correct?
Dr. Jessica Altman:
Correct. So, the treatments all stem from a chemotherapy backbone. And there are more intensive chemotherapy regimens that usually involve a long, in-patient hospitalization and less intensive chemotherapy regimens. Those chemotherapy regimens can sometimes be combined with targeted therapy based on the genomic structure or the mutations present in leukemia cells.
Stem cell transplant is also an option as well?
Dr. Jessica Altman:
Stem cell transplant is an option that is utilized ideally after the leukemia is in remission as a way of maintaining disease control.
And for some patients, that is the best approach for a curative option, and some patients’ leukemia does not require a stem cell transplant.
Clinical trials available as well for AML, doctor?
Dr. Jessica Altman:
So, we feel very strongly that the best treatment strategy for most patients is a well-designed, appropriate clinical trial for all phases of AML therapy. It’s because of research and clinical trials over the last number of years that we have had advances and more approvals for the treatments of Acute Myeloid Leukemia.
So, when you’re talking with your patients, what kind of things are you considering when determining how to best treat AML?
Dr. Jessica Altman:
So, that’s a great question. This is something that is the basis for the entire conversation that I have with my patients and their family members.
I consider patient goals and patient fitness, other medical conditions, and a lot about the biology of the leukemia. If someone has an acute leukemia that is expected to be highly sensitive to intensive chemotherapy, then that is something that we want to think about. Versus if the patient has a disease that is not expected to be as sensitive to intensive chemotherapy, we frequently like to consider other alternatives in that space.
So, in terms of options, as a patient what kind of things should I be thinking about when I’m working with you as my doctor about what the best treatment for me might be going forward?
Dr. Jessica Altman:
So, I think the goal of the initial meetings and the initial consultation between a patient and their healthcare provider is to explore those things. We take a detailed history, understanding patients’ other medical issues. In addition to that, the social history and patients’ goals are very important, as things are not always a yes or no.
They’re not dichotomous choices. And to be able to understand a patient’s goals, and for the healthcare provider to be able to explain what the intent of treatment is helps both parties come to the right decision for that individual patient.
https://powerfulpatients.org/pen/wp-content/uploads/How-is-an-AML-Treatment-Approach-Determined_-1.png600600Kara Rayburnhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngKara Rayburn2019-09-17 08:32:532019-09-17 08:32:53How is an AML Treatment Approach Determined?
So, I think that in differentiating relapsed and refractory multiple myeloma, they sometimes get lumped together and you might say relapsed and refractory myeloma. And that’s partly because that’s groups of patients who are included in the same clinical trials or different things like that. But they are different things. A patient who is relapsed may have been off treatment for a substantial amount of time before they relapsed. A patient with refractory multiple myeloma, they may be refractory to just one type of medicine.
You may be refractory just to lenalidomide if you’re myeloma progressed or relapsed while you were taking it, or it may mean that you have not responded very substantially to any of the medicines you have received so far. So, there are different categories even within refractory myeloma. Whether it’s just to one or multiple different medicines, or if it’s more broad where we’re having a hard time getting a response with even different combinations.
https://powerfulpatients.org/pen/wp-content/uploads/Relapsed-and-Refractory-Multiple-Myeloma_-What’s-the-Difference_-1.png600600Kara Rayburnhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngKara Rayburn2019-09-17 08:12:162019-09-17 08:12:16Relapsed and Refractory Multiple Myeloma: What’s the Difference?
I think being diagnosed with myeloma can be a big shock, so I think the first step is to sort of take a beat and work on getting the logistics of care lined up. I think the first thing you want to do is make sure you have a care team in place you’re comfortable with. That means support from friends and family. It also means providers you’re comfortable with. Usually you’re diagnosed by an oncologist and hopefully that’s somebody that you already feel a good comfortable relationship with.
I always think it’s worthwhile to consider getting a second opinion, another voice. And that could be even if you’re diagnosed at the most high-power academic center in the country, or whether it’s in a more community-type setting. I think having another voice just to make sure everything makes sense, that it seems fairly consistent, and that you understand things as thoroughly as you can. But you do want to get the ball rolling in terms of making a care plan and moving towards therapy if that’s the next step, without taking too much time.
So, I think it’s kind of a balance between making sure you’re really comfortable with all the participants in your care team, whether that’s one or more physicians if you have a primary and somebody else who helps to consult or guide as a more specialized voice. But also balancing that with moving towards the next steps in your treatment because often it is fairly time-sensitive to get going with management of the myeloma.
I think that the initial conversation can be a pretty complicated one. It’s one where we want to take plenty of time to work through a variety of different questions. I think some of the most important questions can be fairly open-ended ones. Ones that sort of help to take the conversation to maybe more broad areas. So, asking things like why. Is there a specific reason why we’re choosing this approach? What are the goals for our treatments?
So that everybody can try to get on the same page in terms of understanding what the rationale is, maybe making sure that nobody is missing anything in terms of what a patient’s goal is and that those are in line with the providers and that those priorities are understood.
I also think it’s important to ask pretty specific questions. I think lots of patients are pretty good about that in terms of trying to nail down expectations for logistics of medicines, things that we should expect as we start with treatments. So, I think it’s a balance between making sure we get into those fine-tuned details as well as taking a step back and asking those broad questions so that everyone can make sure that they’re seeing things in a similar way.
https://powerfulpatients.org/pen/wp-content/uploads/Overwhelmed-By-a-Myeloma-Diagnosis_-The-Key-Steps-to-Take-1.png600600Kara Rayburnhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngKara Rayburn2019-09-17 07:45:152019-09-17 07:45:15Overwhelmed By a Myeloma Diagnosis? The Key Steps to Take
If you have not been up to date with healthcare news, or do not work in any healthcare related field, you may be unaware of the gradual increase how reliant the sector is on technology. Every facet of society has been on an upward climb with how digitized it is, and healthcare is no exception. From breakthroughs as interesting as robotic surgery to standardizing electronic patient notes, both primary and secondary care have grown accustomed to the benefits of how artificial intelligence can benefit them.
In healthcare, introducing new treatment whether based in technology or pharmaceuticals is highly expensive, though great efforts are being taken to increase efficiency, reduce human errors and improve healthcare overall. In the long running of things, this would save the healthcare economy billions in coming decades.
There has been a public declaration made by IBM Watson Health to incorporate artificial intelligence to the ongoing battle against cancer. The focus currently lies with later stage cancer patients who are at their most critical points. This is because it is likely current treatments have failed for them, or aren’t strong enough. New treatments could offer them the best chances when facing their life or death situations.
Specific genetic factors involved in cancer can be identified and targeted with idealized therapies. This offers hope to many Veterans in the US, and cancer patients worldwide.
It has been about three whole decades since a new effective antibiotic has been discovered. This has led to a seemingly losing battle with the emergence of more superbugs (antibiotic resistant pathogens) significantly often. The journey to discovering new drugs is very expensive, meaning many drug companies have slowed down the process of discovery. However, Pfizer’s use of IBM Watson (technology that utilizes machine-based learning) is pioneering the path to finding new drugs that are active for cancer and immune therapies.
Other drug companies such as Sanofi are using artificial intelligence to find new therapies for metabolic disease; Genentech are also leading the way in cancer research with artificial intelligence from Cambridge, Massachusetts.
The correct term for this is robot-assisted surgery, because though it looks like a robot is handling the surgery from the operating theatre, there is actually a surgeon (or multiple surgeons) that are controlling the robotic tools remotely. This has been rolled out successfully in multiple countries so far. These include the United Kingdom and Dubai. The major benefits of robot-assisted surgery is increased precision and accuracy. There is less room for human error, and more room for improved patient care.
One of three or sometimes four main branches of prevention, secondary prevention relates mostly to medical imaging. There has been a huge surge of technological advances in this area in the past century. The simple ultrasound has become 3D imaging and the simple radiograph has become detailed computerised tomography. New approaches can now be taken, that reveals more information about patients. This leads to clearer imaging, faster diagnosing and better results.
Genetic screening has been more incorporated into healthcare since the sequencing of the human genome in recent decades. With genetic information and associations readily available, more accessible means of accessing patient DNA have been developed. There are now easy methods of reaching a patient’s genetic code and assessing their risk for certain health issues that carry genetic risks.
“Polygenic scoring weighs the linear combination of multiple small genetic variations and are used in predisposition assessment,” says Mary Crawford, tech blogger at Australia2Write and Write Myx.
Nursing is investing in the development of virtual assistants, which can take over the role of healthcare assistants and push the healthcare staff population to higher fields of work. Healthcare providers will then be able to maintain continuous contact with patients.
Better Data Security
A major leap in healthcare is digitizing patient records, and rolling out a singular way of standardizing them across the country. Though this is extremely useful for transferring patients from healthcare provider to healthcare provider, it creates room for a cyber-attacks that will steal sensitive data.
“As artificial intelligence increases with patient data storage, it also increases with cybersecurity. Extra security is essential to patient protection,” says Erick Schmid, data analyst for Brit Student and Next Course Work.
Discussing how healthcare may become revolutionized by artificial intelligence may conjure up images of the 1985 movie Daryl. However, the movements are very much real and non-fictional. Productivity is on the rise and medicine has become more business-minded.
Due to its benefits, artificial intelligence is certainly gaining popularity in the healthcare industry and there are developments every year. There are predictions that the involvement of artificial intelligence will grow by 1000% by 2015, pushing it to become a 13 billion dollar industry.
Michael Dehoyos is a medical Blogger at Phd Kingdom and Academic brits. He assists companies in their marketing strategy concepts, and contributes to numerous sites and publications. Also, he is a writer at Case Study Help, academic service.
Michael Dehoyos is a medical Blogger at Phd Kingdom and Academic brits. He assists companies in their marketing strategy concepts, and contributes to numerous sites and publications. Also, he is a writer at Case Study Help , academic service.
https://powerfulpatients.org/pen/wp-content/uploads/How-Healthcare-May-Be-Improved-With-Artificial-Intelligence.png600600Michael Dehoyoshttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngMichael Dehoyos2019-09-12 11:31:262019-09-12 11:31:26How Healthcare May Be Improved With Artificial Intelligence
Care coordination  in medicine is a gold standard goal – it’s a core part of quality improvement efforts across the healthcare system. But, in the words of every kid in the back seat of a car on a family road trip, “are we there yet?” The answer is, “no, but we’re getting closer.”
The US Dept. of Health and Human Services Centers for Medicare and Medicaid Services – a mouthful reduced to the acronym “CMS”, thankfully – initiated an Oncology Care Model  in 2015, which impacts Medicare and Medicaid beneficiaries, as well as people covered by private insurance payers participating in the program. There’s an interactive map of participating oncology practices here .
What this means on the front lines of cancer treatment – in oncology clinics – is that there is a core set of measures for care coordination  that any oncology group can follow, like a road map. Looking at the actual map, linked in the previous paragraph, of where the cancer care coordination model is in use reminds me of cyberpunk sci-fi author William Gibson’s evergreen quote , “the future is here, it’s just not evenly distributed.”
One of the reasons that coordination of care is hard in the American healthcare system is that we don’t really have a national healthcare system , we have a patchwork of 50 state systems for private-payer and Medicaid coverage, with a national system for those on Medicare. Coordination of care in the United States requires being able to take information from a variety of sources, some of which are in competition with each other over revenue they gain from having that information. CMS, as a national care system, has some policy and market power to dictate  “you guys will cooperate, or we’ll take action to make you cooperate,” but given political realities, that power is sometimes blunted by industry influence.
“Are we there yet?” “No, but we’re getting closer.”
What this means, on the ground and in the real world of cancer treatment, is that there’s an opportunity for patients to improve the coordination of their own care, and communities to push for better care in cancer treatment clinics, using this same road map of care coordination measures.
If you, or someone in your family, is dealing with a cancer diagnosis, here are my recommendations for turning the Oncology Care Model into your own care coordination road map:
If an oncology practice in your community is participating in the CMS Oncology Care Model program, consider them as a first-choice option, and find out if that practice is in-network on your health insurance plan
Ask the oncology practice treating you if they provide 24/7 access to clinical staff who can see your medical record, and who can answer questions about your treatment, including side effects and other issues that can arise during cancer treatment
Ask if the practice treating you has patient navigators who can help coordinate care within and outside the oncology clinic – with your primary care team, other clinical teams for any other chronic or acute health conditions you may have
Ask if the practice treating you has financial counselors who can help you with figuring out costs for your treatment, what costs are covered by your insurance, and how to get help with out of pocket expenses related to deductibles and co-pays
Ask your oncologist how your treatment protocol is supported by nationally recognized clinical guidelines for treatment of your type of cancer
It’s only when patients and clinical care teams work together that treatment outcomes improve, and quality improvement efforts across the care delivery system also improve. Care coordination – are we there yet? Now, but we’re getting closer … if we all work on this together.
Casey Quinlan covered her share of medical stories as a TV news field producer, and used healthcare as part of her observational comedy set as a standup comic. So when she got a breast cancer diagnosis five days before Christmas in 2007, she used her research, communication, and comedy skills to navigate treatment, and wrote “Cancer for Christmas: Making the Most of a Daunting Gift” about managing medical care, and the importance of health literate self-advocacy. In addition to her ongoing work as a journalist, she’s a popular speaker and thought leader on healthcare system transformation from the ground up.
https://powerfulpatients.org/pen/wp-content/uploads/Are-we-there-yet_.png600600Casey Quinlanhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngCasey Quinlan2019-09-10 09:38:502019-09-10 09:38:50Care Coordination in Cancer – Are We There Yet?
Taking care of a loved one can be one of the most rewarding experiences, especially if you have had a great relationship with that loved one. While the overall involvement in a senior loved one’s life as a caregiver might be satisfying and make you feel happy or proud of working together, there are times when it can lead to mental and emotional burnout. After all, you are constantly required to nurture and care for another human being which could cause you to forget to care for yourself, leading to “caregiver fatigue” or also known by the popular phrase, “caregiver burnout.”
According to the National Alliance for Caregivers, on average, family caregivers spend around 24 hours a week providing care for their loved ones. I personally was spending anywhere from 20-30 hours weekly while taking care of my grandmother. It really depended on the week and the needs that came up. But sometimes, it felt like much more time was being spent taking care of my grandmother rather than myself.
What I learned during the process was that the best way to avoid caregiver burnout was to identify when I felt I was going through it. Then, to prevent it. Which led me to highlight some signs linked to caregiver burnout.
Signs leading to caregiver burnout
The following signs point to caregiver burnout:
Tiredness and a lack of energy for activities that you could, previously, easily perform.
Having trouble sleeping.
You no longer enjoy activities, specifically hobbies, that you loved.
Relationships with loved ones start to become strained.
Frequent headaches and/or body pain.
You are easily irritable.
The above list of signs isn’t exhaustive but contains the most common signs that caregivers start to experience prior to or during burnout. While the above list is specific for emotional burnout, physical burnout is also important to avoid. Most caregivers face it from having to carry their senior loved ones from room to room or up the stairs or not getting proper sleep.
It is vital that our loved ones utilize technology that is available to them such as wheelchairs, canes, and even stairlifts for elderly persons to take that burden off of yourself. You can help with this by making a list of mobility or technology devices that can benefit both of your lives and take the stress off of your body. While your senior loved one may not be very keen on the idea of using mobility devices (not all are), you’ll need to reason with them why the device is a necessity for them and yourself. Hopefully, they’ll end up understanding the needs of both of you.
In any case of burnout, as soon as you start to experience the signs, it is important you take a step back and analyze why you may be burning yourself out. You need to ask yourself the following:
Is being a caregiver for a loved one too much for me to handle while keeping my job and other responsibilities?
Am I overly consumed with looking after a loved one that I no longer take time during the week for myself?
Am I not eating well or finding time to exercise? This can take a toll on you both mentally and physically.
Do I still have a healthy relationship with my loved one? If you feel like you don’t, for whatever reason, then this could be causing you extra stress. Not to mention, your loved one might be feeling the stress as well.
These questions will help narrow your problem leading to burnout so you can avoid and rectify it. Most caregivers do the following to avoid or combat burnout:
You alone may not be able to provide full-time support for a loved one. At times many caregivers are juggling family and a job along with providing care. This, of course, is a lot to juggle and usually leads to stress and mental/physical breakdowns especially when taking care of a loved one going through a long-term recovery. Which is why you need to take breaks and at times, seek the help of professional caregivers or other family members to assist you. It doesn’t have to be every day but taking a break two to three times a week can make a huge difference and help prevent burnout.
By taking time out for yourself, you can also improve your relationship with your loved one. Personally, a break allowed me to focus on myself, which made me less absorbed on just my grandmother. I usually exercised or spent time with friends which kept me grounded.
Before I started to take breaks, I felt I was more irritated and disgruntled from time to time with my grandmother, mostly because I felt I was not getting time to do anything but take care of her. But by taking some time off from my caregiving responsibilities, I no longer felt this way which definitely made our relationship better. Even she started noticing that I was acting happier and my overall outlook about the situation was then positive.
Talk to family members or other caregivers
Humans find comfort in discussing their problems. Just the process of venting helps us get a lot off our chest. Which is why caregivers should look towards family members and other caregivers to talk to about any problems or additional stress they may be taking on. It doesn’t necessarily have to be to seek a solution but just to vent their feelings out so you stay refreshed and grounded.
I sought refuge in a friend who was also taking care of a loved one who recently went through a stroke. We would talk 2-3 times a week to listen and comfort one another. By sharing my thoughts with others, I let go of a lot of steam that I would normally store.
Most of it was just things I had to let go of, but of course, keeping it in did hurt the relationship I had with my grandmother. The more I got off my chest while talking to family and other caregivers, the more comfortable I was. Especially while talking to other caregivers because it made me realize that others also shared similar feelings and I wasn’t alone. This helped me to refocus my mindset with a positive outlook and created a stronger, deeper connection with my grandmother.
If you find yourself experiencing the signs listed above or you already believe that you have caregiver burnout, know that you aren’t alone. The best thing you can do is try to find what works for you to better your mindset. Maybe you don’t feel like you’re the issue and that your loved one is causing the exhaustion. Whatever the case, take a step back, analyze the situation, and find a route to channel your emotions. Don’t assume this is an overnight thing, consistency is key to constructing a relationship and removing negative energy.
Natasha is a firm believer in health and wellness for all ages. Having been a family caregiver for her grandmother, she knows what it’s like to go through family trials and tribulations. She is currently a blogger who wants to aid others in understanding the tips of healthy and safe aging that she has come across with her own personal experiences as well as through deep research on the topic.
https://powerfulpatients.org/pen/wp-content/uploads/What-You-Should-Know-About-Caregiver-Burnout-and-How-to-Avoid-it.png600600Natasha Woodshttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngNatasha Woods2019-08-29 12:36:352019-09-02 12:31:59What You Should Know About Caregiver Burnout and How to Avoid it
When you go through something as stressful, traumatizing, and life-altering as cancer, you may come out on the other end of the tunnel feeling like you were just put through the spin cycle. There’s no “normal” way to respond to a cancer diagnosis, treatment, or remission prognosis, and you should never force yourself into taking on one specific emotion or perspective. You may feel angry, sad, scared, hopeful, or joyous, and all are perfectly acceptable responses to have.
Regardless of how the experience left you feeling, it’s important to work at moving on and processing it in a healthy way. Here are a few ways to help you do it.
Measure Your Mental Health
You’ve spent the last several months or years caring for your body to the point of exhaustion. Now it’s your brain’s turn. Depression, anxiety, post-traumatic stress, and cancer fears are quite common among survivors. In fact, between 18 and 20 percent of adult cancer survivors report symptoms of anxiety, while almost 80 percent of survivors experience some level of fear of recurrence. It’s vital that cancer survivors and patients alike are constantly looking inward and taking daily measurements of mood and general well-being. If you experience any persistent, negative feelings, be sure to seek out advice from a licensed mental health professional.
Focus on Daily Self-Care
Because your daily life was thrown completely off track during treatment, it can be hard to settle back into a healthy routine when it’s all over. Implementing certain self-care practices into your day-to-day life can help you stay mindful and prevent you from slipping into prolonged states of anxiety or depression. It will help you immensely to pick up healthy self-care practices, such as yoga, meditation, or long evening baths. Integrating weekly or bi-weekly social time will also help quite a bit, especially if you’re spending time with people who share similar interests or experiences.
Work on Rebuilding Self-Confidence
Though we’re ever-grateful that they exist (and save thousands of lives each year), chemotherapy, surgery, and radiation take a massive toll on our bodies. They leave us looking and feeling burnt out and exhausted, often grinding the last little bit of self-confidence we have into a sad, lifeless pulp. Even if you’ve never been a particularly vain person, your life post-cancer is time to help you regain your self-worth at every turn, and it’s perfectly okay to spend some time making yourself feel beautiful both inside and out! Here are some great ways to do it:
Regrow a Full Head of Hair
If you lost your hair during chemotherapy, there are a few cutting-edge hair loss treatments to consider. Though they’ve only been cleared to treat hair loss due to androgenetic alopecia by the FDA, many people find that low-level laser therapy devices help hair to grow back  quicker and healthier after treatment. Luckily, while it takes a little bit of time, most cancer patients are able to fully grow back their hair.
Work on Getting Back to a Healthy Weight
Cancer patients know that the constant barrage of chemicals and harsh treatments can seriously mess with our weight. Weight loss is one of the most common symptoms of both cancer and treatment, with between 40 and 80 percent of patients reporting weight loss and cachexia (wasting) from diagnosis to advanced treatment. Working with your doctor or a dietician will help you return to a healthy weight in a safe way. He or she will design a diet and, if needed, prescribe medication to help you manage your weight.
Treat Your Skin and Nails
Hair isn’t the only physical feature that takes a beating during the treatment process. Chemotherapy and radiation can leave skin red, dry, itchy, or discolored, and it tends to leave nails cracked, infected, or yellow. A full-blown spa day is in order after you’ve recovered from your final treatment. Make sure to also see a dermatologist, especially if you’ve seen any serious changes in your skin since you were diagnosed.
Connect with Other Survivors
Building up a strong social network is vital to staying happy and positive post-cancer, and nobody will help you get there faster than fellow survivors. Like anything on this list, make sure you ease into it and wait until you’re fully ready. Having to recount your experience before you’ve fully processed it can worsen symptoms of post-traumatic stress, depression, and anxiety. But, after a period of time, it will help you feel stronger and more secure when you have a group of friends or family members to share your experience with. You can use the American Cancer Society’s resources database  to find specific support groups in your area.
Get Enough Exercise
Medical experts consistently say that exercise is among the most important components of a healthy life during and after cancer. One of the biggest reasons for this is that, though it sounds counterintuitive, getting physical can help reduce the ever-present cancer fatigue while also helping you get better sleep, reducing symptoms of depression and anxiety, and helping you build back muscle strength that may have deteriorated during treatment. Just be sure to follow all medical advice as you ease back into exercise, especially if you’ve recently had surgery.
Volunteer for a Research Foundation
If you’re experiencing any feelings of sadness, anger, or hopelessness, it can really help you to get involved in cancer-specific organizations that donate to research efforts. Finding a cure or at least more viable treatment options for this devastating disease is certainly on the horizon, but getting there takes a lot of money, resources, and effort. Getting involved can help you connect with other survivors and hopeful people, which will lead you into a deeper state of happiness and optimism.
Let Yourself Experience Loss, Pain, and Joy
Again, there’s no “correct” way to experience cancer, no matter if you’ve just been diagnosed or have just finished your final round of treatment. The most important thing you can do is to constantly take stock of your feelings, being careful not to suppress them, and do everything you can to stay healthy both mentally and physically every step of the way.
Shane McCarthy is the Content Director for Capillus, the world’s first, clinically-proven, FDA-cleared laser cap to treat hair loss. Shane works to share informative and engaging content based off of the struggles and prevention of adult hair loss and thinning. In his free time, he enjoys spending time out on the water wakeboarding and fishing.
https://powerfulpatients.org/pen/wp-content/uploads/Facing-Forward_.png600600Shane McCarthyhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngShane McCarthy2019-08-27 12:35:282019-09-02 12:31:59Facing Forward: How to Move On After Cancer Treatment
Bias – noun – prejudice in favor of or against one thing, person, or group compared with another, usually in a way considered to be unfair.
Humans are, by nature, biased in favor of their own group – village, country, race, social status – over “others” from outside that group. This tendency toward bias against those different from us is rooted in how humans process the information they get from their surroundings – “is that friend or foe?” is a pretty basic processing form. If someone looks, talks, or smells “different,” the most basic parts of the human brain can start firing warnings about stranger danger. That’s called a cognitive filter, or cognitive distortion .
How does this impact medicine? Since medicine is a human endeavor, everyone involved is bringing their own implicit biases  into the room with them. It’s human to feel a little uncomfortable with someone who looks, or acts differently than you. However, in a medical setting, what happens when a clinician “others” a patient? Or when a patient does the same thing to a clinician? My educated guess is that this drives down positive health outcomes, creating burnout in clinical staff and hampering recovery in patients.
I’m not the only one asking questions about bias in medicine. My fellow funny person (I am, after all, the “comedy health analyst ”) John Oliver devoted most of a recent episode of his HBO series “Last Week Tonight” to the topic , which I’d say is required viewing for anyone interested in this segment of health policy. In the piece, Oliver and his crew stack up some serious evidence of racial and gender bias in medicine, particularly in the cases of women having heart attacks , and women of color giving birth .
How should we – all of us, patients and the clinicians who prove our medical care – address this issue? A good first step would be to recognize that we’re all a bit racist  (link is to a Psychology Today article with that very title), which would at least put us in a frame of mind to question our assumptions about the person in front of us in the clinic, or the exam room, or the hospital bed – whichever side of the stethoscope we’re on.
If you’re willing to take that first step, your next step could include taking any of the Teaching Tolerance Project Implicit  self-tests on bias with regard to gender or race.
“I wouldn’t have seen it if I hadn’t believed it” is a quote often attributed to Canadian philosopher Marshall McLuhan  – a perceptive twist on the “seeing is believing” aphorism, one that asks us to challenge our assumptions about the people we encounter in our daily lives, in medicine and beyond.
Self-awareness leads to a better understanding of others. Better understanding of others leads to less distrust, and more cooperation between individual humans, and among the groups we gather in. Which just might improve human health overall. Let’s test that theory, shall we?
Casey Quinlan covered her share of medical stories as a TV news field producer, and used healthcare as part of her observational comedy set as a standup comic. So when she got a breast cancer diagnosis five days before Christmas in 2007, she used her research, communication, and comedy skills to navigate treatment, and wrote “Cancer for Christmas: Making the Most of a Daunting Gift” about managing medical care, and the importance of health literate self-advocacy. In addition to her ongoing work as a journalist, she’s a popular speaker and thought leader on healthcare system transformation from the ground up.
https://powerfulpatients.org/pen/wp-content/uploads/Bias-in-Medicine-An-Untreated-Epidemic.png600600Casey Quinlanhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngCasey Quinlan2019-08-23 15:01:032019-09-02 12:31:59Bias in Medicine - An Untreated Epidemic
As patient advocates we are highly motivated to make things better for others. Our commitment and passion for the work we do can lead us to take on more activities with ever-increasing demands on our time and energy. All of this we do willingly, but this work doesn’t happen without a degree of personal cost. “If we are living with the condition, it is personal beyond measure,” writes diabetes advocate Renza Scibilia. “If we are caring for someone and advocating for them, there is a different sense of pressure and investment. And if we decide that this is ‘a calling’ and do it professionally, there is a difference again as we try to work within different parameters – the need to keep within the realms of what our work allows, and the less structured realities of actually living with a health condition.”
Commenting on the nature of patient advocacy, therapist Karin Sieger  points out, “this area can be heightened with emotions because lives can depend on it and often advocates themselves are directly or indirectly affected by patient care aspects or illness they are advocating for. It stands to reason that those involved in advocacy will be at the receiving end of emotional, mental and physically draining activities.” Given this fact, it’s not uncommon to experience symptoms of burnout the longer we work in the field of advocacy.
“This is a real thing,” says patient leader and two-time cancer survivor, Shari Berman . “Working without pay but as a patient leader is recipe for burnout especially when you feel like the needle isn’t moving.” As metastatic breast cancer patient and advocate, Julia Maues  says, “Oh the burnout is so real and so unique. For once, many of us have the same illness as the people we are advocating for. It’s like advocating for better lives for prisoners while being jail ourselves.”
What is burnout?
Burnout is a state of chronic stress which occurs when we’ve taken on too much and in the words of Sieger, “overstepped our coping threshold.” Scibilia describes how she has “found myself at that breaking point on more than one occasion when the system is failing me, and equally, when I see it failing others and I can’t help.”
One of the lesser acknowledged contributing factors to burnout, particularly in the field of cancer advocacy, is the emotional toll of losing friends to the disease. As Susan Zager, founder of the non-profit organization, Advocates for Breast Cancer (A4BC)  describes, “the biggest factor that’s caused me burnout is the intense loss and grief of losing so many friends and family to this terrible disease.” Research advocate, AnneMarie Ciccarella  agrees. “I had to force myself to take a step back from actively supporting individual people in favor of more research advocacy because the losses became unbearable,” she explains. “There are times I’ll look at a particular blog post and start crying when I read the comments. I see comments from so many who are now gone and it’s heartbreaking.”
Pamela Katz Ressler, founder of Stress Resources , draws a distinction between burnout and compassion fatigue which can co-exist with burn-out. “Compassion fatigue is generally rapid onset and often is the result of exposure to extreme suffering or witnessing traumatic events and situations,” she explains. “It can be one event or a cumulative exposure. Burnout can be described as emotional (and physical) exhaustion leading to withdrawal and disconnection from activities that once were meaningful. As advocates, we often expend energy, caring, and empathy as if it comes from a bottomless well.”
Spotting the Signs of Burnout
Burnout doesn’t happen suddenly. It creeps up on us over time, but our bodies and minds do give us warning signs. Symptoms can include physical and emotional exhaustion; impaired concentration; increased irritability or feelings of apathy, detachment or cynicism related to the work you are doing. In the words of Scibilia, “I get tired. I get overwhelmed. I get discouraged. I get disengaged. I get disheartened.
Looking at some of the common factors related to burnout, Sieger points to:
An inability to say ‘no’.
The fear of putting our needs first and in doing so letting others down.
Taking on too much because we want to please, need to control, cannot delegate, want to micro-manage, cannot trust anyone else to do things for or with us, or have no-one to share responsibilities with.
We are not sufficiently in touch with our bodies, minds or emotions to see the tell signs.
We think it is a sign of strength and authority to be able to take on more and more.
We are afraid of becoming replaceable.
We find it difficult to accept, that we can no longer take on as much as before.
If you recognize your own tendency towards any of these factors, you may be at risk of burnout. Katz Ressler advises that “the first step in preventing burnout and compassion fatigue is awareness and recognition that the well of empathy, energy and caring needs to continually be refilled.” The following self-care strategies and tips can help you, in the words of Katz Ressler, “refill the well of empathy to maintain your ability to advocate effectively.”
14 Self-Care Strategies to Address Burnout
“Different people have different ways that work well for them, says Sieger. “Self-care, keeping health boundaries, a healthy diet, limited stress, moderate exercise, sufficient sleep and quiet down-time are the essentials.”
Let’s take a deeper dive into these essential strategies and add a few more to our self-care toolkit.
1. Set realistic expectations. Patient advocate, Liza Bernstein , believes a key element in managing burnout is to set realistic expectations. “One key to mitigating patient advocacy burnout is to recognize our role and agency in trying to manage it,” she says. “It is not easy, once you’re diagnosed with and treated for cancer to reconcile your new physical and emotional reality with the non-cancer person you used to be. So we have unrealistic expectations.” Bernstein describes her “burnout prevention strategy” at the 2018 San Antonio Breast Cancer Symposium. “It was a few months after a surgery and I wasn’t yet 100%,” she explains. “So I gave myself ‘The Talk’ and granted myself permission to do ‘as little as possible’ there; e., I paced myself, took breaks, and didn’t burden myself with ableist expectations. I did more tangible things tuning out the presentation & DM’ing people in my network to connect a distressed newly diagnosed person with a second opinion appointment. Seems like small thing but had big impact!”
2. Take breaks between big projects. Try to avoid jumping from one time-consuming project to the next in order to give your mind and body a chance to recover. “When projects turn into being a tedious chore, that’s a big sign of burn out,” says patient advocate Mary Pettigrew , who advises, “make it a habit to purge the unfulfilling, stressful activities, keep those of value and explore new territory/opportunities.”
3. Learn to prioritize. Ovarian cancer advocate, Dee Sparacio, wrote on her blog  about taking a step back from her heavy work-load of advocacy activities to focus on her priorities. She outlined a list of questions to help her decide which activities to prioritize:
How effective am I at doing that work?
Am I the only one doing that work?
If I am the only one can another advocate/person do it?
How much does the work benefit other survivors/patients?
How many people are effected by the work I do?
Do I ever regret having agreed to do the work and feel that way when I am doing it?
Does the work ever prevent me from doing other things – like hang out with my husband, grand-kids or dog?
Does that work bring me joy?
Remember, to quote Stage 4 melanoma patient, Kay Curtin , “it’s very easy to get caught up trying to fix everyone’ else’s priorities.” These questions can act as a helpful guide when it comes to reassessing your own priorities and what matters to you.
4. Say no. Self-care may involve you saying no more often, which, if you are like me, you might find challenging. There are always new opportunities or requests for your time, but an important element of self-care is the ability to pace yourself. Before you say yes to the next request, look at the time and energy you have in a realistic way. Follow Sparacio’s advice “I review my advocacy work and its impact once a year. I keep what brings me joy -not necessarily that which brings me exposure. The hard thing is learning to say no. If I say no I will provide the name of a new advocate voice. We need to cultivate new voices.”
5. Schedule time for yourself each day. “Schedule time to step away from ‘doing’ and shift to ‘being’. Take five minutes to turn off your phone, notice your breath and release muscle tension in your body,” recommends Katz Ressler. “I’ll hit the beach collecting shells to clear my head, but a simple walk around the block is helpful too,” says Ciccarella, “and when I have nothing left, I give myself permission to hit the sofa and turn on mindless, silly television.”
6. Feed Your Fighting Spirit. Registered dietitian and founder of “Dam. Mad. About Breast Cancer”, Cathy Leman reminds us of the importance of good nutrition in maintaining a healthy balance. “Balanced blood sugar for sustained energy and optimizing your immune system so you stay well are just two benefits of nourishing your body with quality meals and snacks,” she says. “Dried, fresh and frozen fruit, nuts, pre-washed and bagged veggies, whole grains and good olive oils and flavored vinegars can help you pull meals and snacks together quickly and easily.”
7. Control your devices. iPads, computers, and smartphones are essential tools in the patient advocate’s toolkit, but they can consume large amounts of your time and energy. Get in the habit of turning them off as much as possible, particularly before you go to bed at night.
8. Slumber Your Way to Good Health. “With all you have to get done, getting adequate sleep may fall to the bottom of your list,” says Leman “But when you don’t get the sleep your body needs (and deserves!), your overall performance suffers.” A good morning, she advises always begins the night before. “Create an evening ‘sleep hygiene’ routine that signals to your brain and body you’re ready to call it a day. When you’re well rested, you’ll have more patience, clarity of thought and focus to do your important work. And as a bonus? Getting enough sleep helps you make healthier food choices, which supports good health all the way around.”
9. Exercise Your Body’s Need to Move. “You need mental clarity, focus and stamina, and regular exercise is a simple way to tap those reserves,” advises Leman. “Even a 10 minute walk can clear brain fog, deliver nutrients and oxygen to every cell in your body, and build physical endurance for the long haul. Combine strength training, cardiovascular, core, flexibility and balance exercises as often as possible for a well-rounded fitness routine that will keep you moving forward.”
10. Take time for reflection. Taking time, whether it’s sitting quietly on your own, journaling, or speaking with a friend or therapist to reflect on what’s going on for you is important. “It’s important for all of us in this space to pause, assess, and take whatever time we need to reboot,” advises Ciccarella, for whom writing is “a powerful outlet to deal with all of my feelings. Identifying my feelings and their underlying cause allows me to accept the feeling and FEEL it – whether it’s fear, anger, grief -really, any emotion that drags me down.”
11. Don’t go it alone. Whether it’s peer support, or a professional, find a group or an individual who can support you on this journey. “I would even go as far as saying that having another independent professional to support us is essential,” suggests Sieger, “like supervision for therapists and counsellors, where we can talk things over, an outlet for our pressure and feelings.”
12. Intentionally step away from your “tribe” for short periods of time to refill your reserves, advises Katz Ressler. “Detribe” is a term she coined a number of years ago that may seem counterintuitive. As she explains it: “How can we step away from our ‘tribe’ when there is so much to do? Research shows that by intentionally engaging in self-care activities (think meditation, a walk in nature, a cup of tea with a friend) burnout can be reduced or eliminated.”
13. Choose what works for you. “You have to find what works for you,” says Bernstein. “It might not be a massage/spa, it might be doing what you love, giving back, being in nature, taking a nap, patting your dog… it really means being compassionate to you, as if you were your best friend.” Katz Ressler echoes this and advocates practising a spirit of loving-kindness. “Allow yourself to be as kind and empathic to yourself as you are to others. What ‘gift’ would you give someone else to show they are appreciated? Give the same gift to yourself,” she says.
14. Knowing when it’s time to quit. Sometimes the best self-care is to quit. Sue Robins  took the decision to do just that. “I still do advocacy but on my own terms, though writing and storytelling and with individuals. I handled my burnout by quitting the ‘patient engagement’ world.”
“Burnout in patient advocacy is real,” says Terri Coutee, founder of DiepCFoundation.org  . “It takes a tremendous amount of dedication and discipline with the potential of draining your personal emotional and physical energy.” But the good news is that burnout is reversible. By putting the focus back on self-care, you can learn to manage your energy, time, and personal resources better. Although, this too takes self- discipline. “I think it takes discipline (ie, effort) for many of us to remind ourselves we need to practice self-care regularly,” notes Bernstein. As Coutee explains, “choosing the gym, saying no, and letting others take care of themselves are among the many actions requiring discipline. Choose the one that works for you so you can continue the work of patient advocacy with passion without burning out.”
Whichever path to self-care you choose, once burnout is recognized and attended to, it can become a chance to rediscover your commitment to the important work you do as advocates for better care for yourself, your loved ones and your community. Let these tips and techniques be a reminder that YOU are most deserving of the gift of self-care.
A Stanford Medicine X e-Patient scholar, Marie Ennis O’Connor is an internationally recognized keynote speaker, writer, and consultant on global trends in patient engagement, digital health and participatory medicine. A board member of the Patient Empowerment Foundation, a network of people, foundations, organizations and medical institutions dedicated to empowering patients worldwide, Marie’s work is informed by her passion for embedding the patient voice at the heart of healthcare values. She writes about the experience of transitioning from breast cancer patient to advocate on her award-winning blog Journeying Beyond Breast Cancer.
I recently listened to one of my favorite podcasts, “What Should I Read Next.” The premise of the podcast is the host, Anne Bogel, chats with a guest about their reading life, including three books they love, one book they don’t, and what they’re currently reading. In a recent episode, she spoke with a physician who was about to retire. She said that she had been trying to read more books with different genres, as her main focus for the majority of her life and education had been science-based texts. She grew up in the library reading a variety of books and still tries to educate herself by going to lectures and author talks. However, she was looking for more books that focused on the humanities. HUMAN. Which got me thinking about my background in health communication and my passion for health literacy. I know that one of the many reasons that doctors go into the medical field is because they want to help people. They have a strong sense of empathy and the passion to care for others. However, throughout all of the scientific jargon that they retain and medical knowledge that they gain, they may lose the ability to connect one on one with the patient, to really understand what’s going on behind the aches and pains. Plus, office visits with patients are getting shorter. Doctors don’t have the time to really understand what is going on with the patient before they try and get them in and out to move on to the next. They feel rushed, and as a result, the patient can walk out not knowing what happened. According to the Agency for Health Care Research and Quality, a division of the U.S. Department of Health and Human Services, poor communication can have a detrimental effect on people’s health. For example, patients may not comply with doctors’ orders because of a lack of understanding. It can also hurt medical practices as patients have the option to leave doctors who they feel do not communicate well and therefore, a lack of trust develops.1
So how can we fix this? Can we emerge communication education into the medical curriculum, including required continuing medical education? Can we focus on the human connection that led these doctors to practice medicine in the first place?
Here are a few suggestions for physicians:
Pay attention to the patient though active listening. Repeat back to them what they’re saying to develop an understanding.
Use lay-friendly language. Patients come in because they feel sick, something is wrong. Being bogged down with medical jargon isn’t going to help.
Use the teach-back method. Have the patient repeat back what you told them.
Use pictures of graphics to explain complex concepts.
Talk to them about other aspects of their life. It’s not just an illness you’re treating, but a patient with a life outside of the doctor’s office.
Show that you have the time to listen even if time is short. Patients know when they’re being rushed.
What do you as a patient want from your doctor? What do you feel is lacking in the patient-physician relationship?
Carly Flumer is a young woman who was diagnosed with stage I papillary thyroid cancer at the age of 27. She recently received her Master’s degree from Boston University in Health Communication and received her Bachelor’s from George Mason University in Health Administration and Policy. While being diagnosed with the “C” word at such a young age was a surprise, as it would be to anyone, she found strength, support, and inspiration in sharing her cancer journey on social media. As a result of her health outcome, she looks to advocate for other cancer patients through education, research, and health literacy.
https://powerfulpatients.org/pen/wp-content/uploads/Putting-the-back-in-healthcare.png600600Carly Flumerhttps://www.powerfulpatients.org/pen/wp-content/uploads/New-Logo-300x126.pngCarly Flumer2019-08-22 14:30:592019-09-02 12:31:58Putting the Human Back in Healthcare