Susan
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Susan began experiencing numbness running down her neck spine when she turned her head. The local neurologist she saw “dropped” her diagnosis, but after advocating for herself and finding a neurologist with “stronger, more accurate” machines, she was diagnosed with MS at 39. Susan participated in a clinical trial for the MS drug Tecfidera. She agreed to participate when her neurologist asked her because she wanted to help somebody else “down the line.” Susan was comfortable participating because she trial wasn’t in the first stage: “I didn't feel that I was being a guinea pig to take something that was going to harm me, because it had been already identified and put into the next stage.” Susan was not currently taking an medication for MS, so felt she had “nothing to lose.” The trial involved a once a month visit which was “quite a commitment” because Susan lived an hour and fifteen minutes away. There was a lot of testing for the trial - urine tests, blood tests, EKGS, MRIs, neurological tests, and other “games that you have the maneuver and play” – and Susan remembers getting “kind of competitive with myself” about how she did on the tests.
Susan found the trial “fascinating” and asked a lot of questions about where her data and scans would go. Sharing her data didn’t bother Susan; she knew the test results would “just for their knowledge.” One time, she recalls “they did let me in” because her lab values were abnormal from another medication she was taking. Susan knows she was initially in the placebo group and did not receive the trial medication because when she was switched to the trial medication in the second phase she had a bad reaction with itching, diarrhea, and lack of appetite. She called the neurologist to tell him “I think I have the real medication, and I think I have every side effect you want to think about” and stopped participating in the trial. Susan wasn’t upset by spending a year in the trial to find out she is allergic, reasoning “if it can help somebody else, then that's all I was meant to do.” Though she recognizes, “it's all their secret little data that they don't want to share,” she “would have loved seeing a printout afterwards” with the study results. Overall, Susan enjoyed meeting people working on the study and “the learning experience,” finding the “whole process interesting.”
Susan talks about why she wouldn’t participate in a stage 1 trial.
Susan talks about why she wouldn’t participate in a stage 1 trial.
I don't know if I would've partaken in the first stage. It was further down so- well, I don't know that I would not have partaken in the first stage, but stage– stage one is really, really starting and so you're really guinea pigging a lot of people. But by the time you're down into stage two and stage three, you know, it's different because they've isolated some things.
I don't know, though, if I would have done the first stage where they're just testing out things.
Susan describes what she looked for in the consent forms.
Susan describes what she looked for in the consent forms.
I don't– I don’t know. I knew that– I knew from the beginning that when you sign the forms, you don't have legal grounds to anything. You can't ask for your stuff. And I also knew that any time you wanted to quit, you could quit. So that– that was– that was really all you needed to know. I didn't care if they used my data somewhere. It didn't bother me at all. I knew that I wasn't going to get any of my data back. I wasn't going to get any results on anything. I knew that they would let me know if there was something serious about my condition that they were just– not that they would. And that's the one thing I asked. What if something is– you see something and it’s like– needs to be addressed? Are you going to just let me go and not tell me that I need to address something? And they said that was a no. So, I knew that if something really happened and they found something in my blood work or whatever, that they would– that they had an ethical– they had to tell me. And just let it go and say, well, guess what? You know, so that I knew, and I knew you could quit any time. So that's really all that really mattered.
In Susan’s trial, study group assignments changed in different phases of the trial.
In Susan’s trial, study group assignments changed in different phases of the trial.
But you– you go in and you don't know then because I had to take these pills. I think it was four times, three or four times a day. I don't remember. And you get these pills, and they give them to you for the month. And you don't know if they're placebos or the real thing, because that's the study, is your—you know, what group you're in, so they don't know, you don't know.
And then at the end of that time, when we went to the next phase– was the next phase– phase three, I believe, as when they gave everybody– everybody got the medication. But some got at different doses so you didn't know what dose you got, but you got– you got the real drug. Well, I knew I had the placebo the first time I took the first dose of the drug. I knew I had the placebo because I thought, nah, this is something not right about this drug. And then it didn't take me but– I don't know, I think I was only on it 2 weeks, 2 and 1/2 weeks, because I had every side effect. I had itching, and I could hardly eat anything, and I had the diarrhea, and I'm like this is not– so then I had to finally call the neurologist and say, I think I have the real medication, and I think I have every side effect you want to think about. And then I had to stop, and I had to dis-enroll because it was too unsafe. I couldn't– I couldn’t eat. I couldn't keep anything down. So you know, I don't know what dose I was on. Could I have taken the smaller dose and been more comfortable? Maybe so. Who knows?
Susan had to make sure she could take off work to attend study visits.
Susan had to make sure she could take off work to attend study visits.
He just told me about it when I had to go– once a month, I had to go down to [LOCATION] which was quite a commitment. Because, like I said, I'm an hour and 15 minutes away from [LOCATION], so that means I take off of work once a month to go down there. It takes me, you know, a while to get down, a while to have the– the session and then come back. So I had to make sure that at work I could take off, and they were fine with that.
Susan’s husband came with her to study visits.
Susan’s husband came with her to study visits.
My husband and I would go together, so we got used to what time to go, where to go, and we know which way to go. And we got loaded around a couple of times because
[LOCATION] always changes their– remodels and changes their things. We moved from basement to basement, to the next floor to the next floor, but it was fine. I mean, we knew where to go, what to do. We knew the protocol, so it was just like something you get into– it's just– it’s just a long commute back and forth, and especially if you're going to do it in the wintertime when it's snowing, you know, but we managed. It was OK.
Susan talks about being “competitive” with herself on neurological tests.
Susan talks about being “competitive” with herself on neurological tests.
And then you do all the neurological tests. They do you know, the testings on you and games that you have to maneuver and play. It got to be kind of funny because I would– I got kind of competitive with myself, like what I could do faster the next time or what I could do better. And you know if it's stacking things or distributing things, I'm like OK, I can do this faster now.
Susan experienced multiple side effects.
Susan experienced multiple side effects.
I had every side effect. I had itching, and I could hardly eat anything, and I had the diarrhea, and I'm like this is not– so then I had to finally call the neurologist and say, I think I have the real medication, and I think I have every side effect you want to think about. And then I had to stop, and I had to dis-enroll because it was too unsafe. I couldn't– I couldn’t eat. I couldn't keep anything down.
When Susan’s participation ended abruptly due to side effects, she wondered about the trial’s outcomes.
When Susan’s participation ended abruptly due to side effects, she wondered about the trial’s outcomes.
It was sort of abrupt. You know, because you're just kicked off because you can't continue if you have the side effects. And it was just sort of kind of like, “Oh, I'm done.” So, I mean I have to be done, because I couldn't continue. I had to stop taking the medication. But there was no follow-up other than me asking my neurologist, like, “How did it go? And did the drug finally get on the market?” You know, and then I knew, yes, it did. And, yes, your side effects were the major ones that most people, a lot of them, had.
Susan says she would have liked to see the results of her trial.
Susan says she would have liked to see the results of her trial.
And it sounds like you didn't get any results back either about yourself or about the group.
No, but I would have loved to have seen it. And I don't know why at the end you can't, but I know it's all their secret little data that they don't want to share. But it would be– it would be a nice thing at the end of the study to know. And I don't know why you can't because look at the COVID vaccine. I don't know if you have, but I've read the study stuff online, and you can see the percentage of people and how much– what they're– I would have loved to see it. So if you can see it for that, like you see it for mine. So I would have loved to have seen a statistical thing saying these people– this number of people got GI disruptions, this number of people got these symptoms. And maybe you could Google it now and see it—I don't know—in there, because it's on the market. But I just would have liked to have seen some of that statistics.
I didn't mind sharing my data, but, like I said, I would have loved to have got something back. It doesn't– doesn't bother me to share the data. That doesn't bother me at all. No. I just– I just wish I could see something back. Just to know how you ranked or where you were, because it's like you know, it is just interesting to find out.