Clinical Trials

Kara

Outline: Kara was diagnosed with MS the day before her 30th birthday and was immediately hospitalized for treatment. Kara chose to participate in a clinical trial because she was without insurance and needed access to medication.
Background: Kara, age 32, lives in the South in a small city with her two cats. She works as a nurse in two school systems. Kara identifies as a White heterosexual woman.

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Kara was diagnosed with MS at 30 after she began experiencing progressive tingling in her legs as well as vision issues, fatigue, difficulty writing, and generally felt sick. Kara participated in a clinical trial shortly after her diagnosis. Initially she was hesitant to join: “I didn’t have information on it; of course, I'm going to be hesitant.” However, after looking into the company running the trial and receiving all the information, she felt better about participating in a clinical trial as long as she can make sure the trials are “safe for me, and I am the one to choose it”. Overall, Kara was motivated to join a trial as she didn’t have insurance and needed medication.  She had heard positive reviews of Tysabari in the MS community so chose that trial. The consent process was a lot of information about potential side effects and how the medication had affected other people which Kara went over with her neurologist: “I wouldn't just willy nilly sign anything.” Kara felt okay about sharing her data considering that the trial might help the medication be FDA approved. Her message for other people thinking about participating in a clinical trial is “really make sure you're comfortable with it...just don't sign papers and go...really invest in looking at that medicine...that's what your neurologist is here for. That's what the company is here for is to answer those questions...don't be afraid to ask them.”

 

Kara says clinical trials are both similar and different from usual care.

Kara says clinical trials are both similar and different from usual care.

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They do a lot of similar things, you know. With the clinical trial, they asked for—some things are a little bit different. I’ll have to see another neurologist, because it has to be like two—my main neurologist and then a different one will have—that doesn’t like, really take care of me full time, has to also perform a neurological exam. And so, if it’s just me and her, you know, we don’t obviously do that. But other than that, yeah, I mean a lot of similarities. They ask the same, pretty much the same questions.

 

Clinical trials gave Kara access to medication without insurance.

Clinical trials gave Kara access to medication without insurance.

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I have no insurance, and I needed medicine, honestly. And then, I just, I had heard—at least, definitely with the Tysabri, whenever I got more involved with the MS community. I saw— heard so many positive reviews, and, you know, everybody had been very positive with it. So, that’s why I chose that one as well. But yeah, the not having an insurance thing is kind of a big one.

 

Kara's past experience with a clinical trial gave her concerns about joining another one.

Kara's past experience with a clinical trial gave her concerns about joining another one.

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You said that when you were first diagnosed, medications was one of the things that you looked into. I’m wondering kind of what information you were, you were looking for, either then or as you made decisions after speaking with your neurologist?

The main thing is how long it’s been in a clinical trial, the side effects, and then what the treatment would be, how many times a month or a week. And then what kind of things that could potentially have like, side effects; not really side effects, but like things that I need to look for with my blood work, you know. Like the other one was my IGM levels were just chronically low, which means I bruise—I can bump into anything, I mean, I was covered in bruises because of that medicine. In the course with the clinical trials, if they’re able—how long, if I’m able to leave it or not, you know. If I would get penalized for leaving it, if I-, if it’s not doing very well, or just I don’t like it, that’s another thing. Because I don’t want to be stuck doing something if I have to be forced, if I’m miserable, and it’s making me worse. And I don’t want to, you know, have to go through any type of negativity with that brand or whatever.

 

Kara appreciated having time to review information before signing.

Kara appreciated having time to review information before signing.

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A lot, a lot, a lot, a lot of information. And they would like give you the information, and they would send you home with it for a few days, you know, to really look over it, really make a decision. And they were-, very-, wanted you to really, like, invest in it and take a look at it, and make sure this was what you wanted to do. And the information itself had just like a bunch of—it was very—a lot of statistics. And, very medical, as well, as it had a bunch of information that I thought was good, like the, you know, side effects, percentage of the side effects—and, based out of, like, out of this X amount of people; so, you can see, like the mean, median, mode of it. You could see it all lumped together and how, how it’s affected people and stuff. But it was a lot, a lot, a lot. And the information you take home, is for-, well, you know, it’s for you. So, whenever I would go back in, I would get fresh stuff. And I would go over everything with my neurologist, like, with her. I wouldn’t just willy nilly sign anything. But it was very good—like, if I needed more time, I could absolutely have it. There was no rush from the clinical trial people or my neurologist. If it was like, if you want more time, you could have more time, and they were very pleasant about it.

 

Kara did not sign up for trials where she could be in the placebo group.

Kara did not sign up for trials where she could be in the placebo group.

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What did you think about sort of the chance of being in the placebo group or getting the medication?

The-, the clin-, the trials I was at, I was not going to be in a placebo trial, or the placebo group. Like, the placebo group was not an option. So, I don’t remember why with the first one, because it’s been so long, but I was guaranteed, I was 100% guaranteed to get the medicine for-, and, and for the Tysabri as well, like it was a 100% guarantee. And that was another reason why we chose that first medicine was that I needed medicine.

Oh.

And I didn’t-, my neurologist did not-, was not going to put me on any medicine that I could potentially be in a placebo trial. So, that’s why we chose that one. So, I’ve never had a risk for that.

 

Kara scheduled her infusions so that she could go to work in the afternoon.

Kara scheduled her infusions so that she could go to work in the afternoon.

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I would do them early in the morning. My appointments would be early, and then I would go—sometimes I would go to work after, sometimes I wouldn’t. It just kind of depended on how I was feeling. But for the first, I think two, I—I just took off for the whole day. But it sucked, I mean you had to sit there the whole time, you know, for hours. I think the first day was like six hours. And because of, you know, the first dose of med, they have to make sure you don’t—you take Benadryl and Tylenol and all of this other—like, Tylenol and Claritin was for this current medicine. It’s intense, and so—but once I got used to it, I would go, just to have the appointments early and go to work and work my eight hours, you know. That way, like, one to nine or something like that.

 

Kara describes various tests.

Kara describes various tests.

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They take so much blood. Oh, my goodness, oh. For the first, you know, three months, I was at—yeah, I think first three months, I was at the neurologist at least once a week getting between 8 and 20 tubes of blood taken. They’re testing for everything. Which is, you know, I understand why. But yeah, for the first three months of the first medicine, it was a lot. CT scans every once a month, labs every day, and I got the-, I got dosed with the medicine more frequently, and then it stretched out. And like, it was like once a week that it was stretched, it stretched out somehow, because it was kind of a loading dose with it and seeing how your body reacted to it. And it was so much blood; get ready for a lot of blood work. A lot of blood pressure taken like three times in a row. Like back, to back, to back, which is technically bad, because if you do blood pressure like that, it’s going to be falsely high, but that’s beside point. And also, like these games-, mind things, like, you know. You have letters and then shapes, and so when you see the shape, you have to correlate it with the letter, and they time you with that. And just little—just to see if you improve. It’s-, it’s intense for the first little bit. It’s hours. EKGs, so the-, I knew whenever I would go in, I would be there for hours, like literally hours.

 

Kara describes why she felt okay sharing her data.

Kara describes why she felt okay sharing her data.

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No. I mean, I felt fine because it, it was, you know, whatever they took from me is like, you know, hopefully it’ll help someone else. And they’ll able to use my information to maybe get this FDA approved. To add me to the statistics of, like, you know, they worked well, but the-, you know, her IGM levels were low. Initial blood analysis and lumbar punctures are similar, this could happen. So, it really didn’t bother me. It’s this kind of like, I mean, what’s it going to hurt? I don’t, you know—it didn’t, I’m not one of those people that’s like, the government has all my information, and, you know. No, I’m not that way at all. Because I’m just like, I have nothing to hide from, you know. I don’t have anything to hide, so I might as well just use it for something good.

 

Kara explains how clinical trials help with routine care while uninsured.

Kara explains how clinical trials help with routine care while uninsured.

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I haven’t had insurance since 2000—December 2019, and so, I’ve been supplementing with the clinical trial. Because, I had—it’s two different ones I was on at the very beginning, in March 2019, and a different one from now. And it’s been able to help me, be able to see the neurologist. It’s paying for my infusion, and any CTs, and any blood work, because it’s-, it needs for, you know, its stuff. So, I’m able to get-, use all-, use that as my benefit to see my neurologist, and, you know, not have to pay out of pocket, and stuff like that.

 

Kara had to leave her trial due to side effects.

Kara had to leave her trial due to side effects.

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They knew about the IGM levels would be low, and they had a window to where you can get it, like, to get it brought back up. But if you don’t get it brought back up, they would eject you from that trial, because I mean, you can’t get the medicine. So—and they give you—and then you can extend it, too. If you want to try it for, like I think I extended it a month—I was able to do that too, because I told them everything, I was doing in order to try to bring them up. And they were like, “Well, let’s extend it another month and see. Keep doing what you’re doing.” And it didn’t work. And it didn’t work enough, rather, it worked like two points. And they actually ejected me from it, but I wasn’t penalized for it. I could not help that I—the medicine caused this. I—it’s not my fault I couldn’t get it back up.

 

Kara urges people to do research about each trial and make sure they are comfortable joining.

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Kara urges people to do research about each trial and make sure they are comfortable joining.

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I say if you have a chance to do a clinical trial, make sure you really—make sure you’re comfortable with it. I had to make sure I was comfortable with the medicine, and I looked into it—just don’t sign papers and go. I really invested in, because this is an unknown medication that’s not FDA approved that you’re putting into your body. I feel like, you know, you really need to invest in figuring out what side effects could occur and getting to know what labs to look for with that. Like, what are the critical—like IGM, I knew that was my critical lab. So, just kind of—don’t just sign and go. Really invest in looking for, looking at that medicine. You know, I’m glad you trust your neurologist; however, you shouldn’t just do something willy nilly.

And if you do go into, say, a clinical trial, read the paperwork, read the articles, call the company, invest in stuff—you’re putting this into your body, that is not FDA approved. You need to make sure that you are comfortable, everybody’s comfortable, and that’s what they are here for. That’s what your neurologist is here for. That’s what the company is here for—is to answer those questions. And don’t be afraid to ask them. And be honest with your neurologist, you know, like if you are having symptoms, or if you’re not sure if they’re symptoms. Make sure you ask and make sure you bring that up. That’s what they’re there for. If you’re, like—whenever I wasn’t sure if I was having a relapse or not, I went to my neurologist, we talked, I got blood work because I wasn’t sure. And that was OK, because I didn’t have a relapse.

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