Liz
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At 23 years old, Liz experienced her first symptom when she fell to the floor one morning and was unable to move for about an hour. Over the next few years, symptoms persisted, including numbness, tingling, and clumsiness, that would resolve after a few weeks or months. Twenty years later, Liz experienced an intense pain like an electrical shock in her leg and arm, which led her to make an appointment with a neurologist. The neurologist tested her for MS through a brain and cervical MRI, an EMG, and a lumbar puncture. At 43 years old Liz was diagnosed with MS.
Liz’s experience with medication clinical trials was a substantial part of her treatment history. After relapsing while on Copaxone, Liz worked with her MS specialist to decide on a different medication. She chose a newer medication called Tecfidera because of the promising efficacy. At the same time, there was an ongoing phase four study of the efficacy of switching from Copaxone to Tecfidera. During the study, Liz experienced gastrointestinal issues when taking Tecfidera but after receiving advice from her MS specialist, she found that eating peanut butter after taking the medication resolved the issue. During this year-long clinical trial, Liz went in for blood work, MRIs, full neurological exams, and appointments every few months.
A relapse after being on Tecfidera for two and a half years prompted Liz to switch medications. At the time, Ocrevus was being studied for FDA approval and Liz’s doctor asked if she would join the clinical trial since because fit the study criteria of having “been on a couple previous Disease Modifying Treatments that had not worked well enough.” Liz chose to participate in a 2-year, phase three study of Ocrevus for several reasons. Liz had her neurologist’s support and felt that she would get “just as much good care or better” because of the increased frequency of MRIs, blood work, and surveillance of MS progression associated with the trial. Throughout the study, Liz always had someone” she could call with questions or issues. Overall, the study “went well” for Liz and she is still on Ocrevus.
Liz’s decision-making around trial participation involved a lot of discussion with her husband “looking at the study, looking at what is required and requested, and looking into what they already knew about the particular medications.” She also spent time discussing the decision with her doctor and her sister who was, at the time, participating in drug studies for stage four breast cancer. Liz’s participation in clinical trials stems from her being a data-driven person who was always for trying to advance things and trying to improve. Liz sees her decision to participate in clinical trials as a way to understand her MS and do whatever she could to help herself and others. At the end of the trial, Liz smoothly transitioned back to regular care because her doctors and the drug company worked together to get the medication approved through health insurance. Throughout the studies, Liz had access to her individual results and was able to monitor the results of the study from the government clinical trials website.
Liz carefully reads information about past studies.
Liz carefully reads information about past studies.
So, I always look at the information, which is probably why I was interested in the different studies. And I don't believe every study that's out there. I think you need to look at the information, look at how it's presented, look at how many people were in the study. And is the information that they're reporting the same as what they were actually testing for is another tidbit. Also, when I said earlier on my husband and I just went through the different drugs at the time and picked the one with the least amount of side effects, well, then you really start to get information on the studies and the side effects. And just because a side effect is listed doesn't mean that 100% of those people had it. It could have been one person out of 20,000 people, but they were in the study. And now, it is a side effect, because that person may have had it even if it wasn't actually due to the drug itself.
A member of Liz’s healthcare team invited her to participate in a clinical trial.
A member of Liz’s healthcare team invited her to participate in a clinical trial.
Just the neurologist that I see is with the [INSTITUTION] here in [LOCATION], actually, [INSTITUTION], too. So, these are the two main hospitals in our area. Both of them are teaching hospitals. They both have been very involved in and learning and so forth. So, if he's able to be involved in a particular study, then they will work on that. So, it just happened to be that, when I had an issue and was switching over, there happened to be a particular study that I fell into. And so, he would just—after I made the decision, though. So, after I decided to go on the Tecfidera, then it was probably a couple of days later. He called and said, “Hey, we have this study. Would you want to be involved? You fit into it, because you chose this medication. We have the study. We want to go for it.”
Liz describes what she consented to as a participant.
Liz describes what she consented to as a participant.
So, in signing up for the study, it was all laid out. There was a whole chart about, week one, you get the MRI. You have to do certain blood work. You have to do all these different tests and so forth. And then, say, week six, you get these other tests done and so forth. So, the whole study was laid out as far as what was required of me and where these tests and things would be conducted. So, I knew up front whether or not I was going to be able to hold up my end of the study or not
Liz emphasizes needing to “be open” when filling out questionnaires.
Liz emphasizes needing to “be open” when filling out questionnaires.
There were also questionnaires and things that I would fill out. And you know, you just really needed to be open about any side effects and any sensations, anything that we were experiencing. Any infections or any medication, anything that I was taking, they needed to know from the study. I don't have really anything negative to say about it. It went well.
Liz had trouble with the trial medication at first.
Liz had trouble with the trial medication at first.
So really then it would have just been the medication, whether I would be able to tolerate the medication or not. I did have a reaction the first time I got the infusion, because the Ocrevus is an infusion at this point. So, they knew what to do, and it was fine. I did get sick. I was due for another infusion 2 weeks later. That's how they kind of titer to you in at first.
Liz describes her experiences with insurance coverage for her trial medication.
Liz describes her experiences with insurance coverage for her trial medication.
So, when you ended participation in the clinical trial, how did that work in terms of going from the trial drug to the drug that you were responsible for yourself, I guess, in a way?
So, it actually didn't go horribly bad, because it had been FDA approved. And then I know that they were quickly working on getting the insurance companies to pick it up. So, by the time I was through the study, the insurance companies, they were working with it. So as far as the facility that I attend, those nurses, the infusion nurses and so forth, they knew what they needed to do to work with the insurance companies on that respect. So, I really didn't have too much trouble switching over. And then I also found out that Ocrevus has a copay program, which is wonderful. Because I probably would have never been able—I would have been working forever to pay for it. So, while Ocrevus is not the most expensive drug to be on, it's at least $60,000 a year for that medication. It's probably more like $65,000 which is phenomenal, but it's not as bad as some. So, they do have a copay program. So that's the only thing is a lot of different drug companies that I found out do have assistance with your copays. I think Tecfidera, they actually have one as well. So, I was able to switch over fairly easily because of that program.
Liz offers advice for making trials accessible.
Liz offers advice for making trials accessible.
So, if you want to be more inclusive, they need to make sure that those people are able to access the study as well, especially if it’s going to be an earlier phase trial—so whether it’s providing transportation and so forth or having the study in a way that, like I said, it’s more encompassing for all and just easy access. And certainly, being straightforward in what is expected and what you’re hoping the outcomes are in the end. And just that feedback, to me, that’s very important as you go along. You would like some type of feedback. And certainly, at the end, you want to know whether or not it helped, whether or not it made a difference.