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‘There Was So Much Hope’: Biogen Trial Participants Are ‘Heartbroken’ After Cancellation

By | March 24th, 2019

On Thursday, Biogen, along with its Japanese partner Eisai, announced it would be canceling two late-stage trials testing their drug aducanumab. The drug was one of the most promising the Alzheimer’s industry had seen in years—in a previous 2016 trial, it was shown to break up beta-amyloid, the toxic protein that accumulates in Alzheimer’s patients that causes neuron death. A team member on that trial called it “the best news” in 25 years of Alzheimer’s research. 

Biogen’s stock immediately plummeted, and news outlets took note—which is how most patients in the trial found on that the treatment they’d been receiving for up to three years was now canceled and was unlikely to have worked. 

We spoke to 54-year-old Jeff Borghoff, who was in the trial for 36 months, along with his wife Kimberly, on the impact this announcement has on trial participants—and what he thinks should change about trials in the future. 

  • Jeff Borghoff found out about the trial cancellation on social media
  • His treatment included a monthly, all-day infusion and several MRIs, PET scans and cognitive exams over three years
  • “This is about people’s lives,” said Borghoff. “We need a more ethical, personable way to receive this information.” 
  • Despite the emotional and physical toll, Borghoff said trial participants “cannot give up hope.” 

Being Patient: Jeff, how did you hear about the Biogen trial being canceled?

Jeff Borghoff: Well, I was sitting in front of my laptop, and a dear friend of mine contacted me who was also in the clinical trial. He said to me, “Hey, buddy. Did you hear the bad news?” Immediately, I just had this sinking feeling that he was going to tell me that the Aducanumab trial had been canceled.

He actually found out about it through mass media and then I stepped away from my conversation with him and then, sure enough, it was just all over the news. Primarily, interestingly enough, it was mostly on financial news platforms, which I thought was a little ironic.

Being Patient: I was also surprised to read about the share prices, thinking, “There are people behind those shares, people who have participated like yourself.” Now, you were in that trial for three years, is that right?

Jeff Borghoff: That’s correct. I think this coming week would have been my 36th infusion.

Being Patient: Kimberly, you must have been shocked as well. Your husband has committed three years of his life and there must have been a lot of hope. I know there was definitely a lot of people hoping that this Biogen trial would work.

Kimberly Borghoff: Yes, I truly believe it did help Jeffrey. It was our hope. I believe it did slow Jeffry’s progression down. He is progressing very slowly, so my fear now is now that he’s off the medication, that the disease will progress quicker. I actually found out at my day job, and I saw a social media notification come up on my phone. I saw that it was Jeffrey’s friend who’s on the Biogen medication. It just said, “I’m very sad.” Even before I clicked on it, Jeffrey was texting me to call him.

I immediately broke down, ran out of my office into the hallway. It was a very emotional time, so much that I came home from work. We just held each other, upset. It’s heartbreaking.

Being Patient: It’s hard to imagine getting such devastating news on social media. Frankly, I’m surprised that no one from Biogen or from the trial doctors informed you sooner.

Jeff Borghoff: I don’t think I can place any blame on the way this was communicated out from my clinical trial group. They most likely found out about this the same time that we found out about it. I think what may have happened is that they probably went into crisis mode and started calling all of their participants. However, you’re not going to be able to keep up with the flow of mass media for them to make sure that they tell everybody before you get your news from social media. We finally did speak to the doctor.

Kimberly Borghoff: The doctor called us personally.

Jeff Borghoff: We have a very close personal relationship with our clinical trial center. They’re absolutely fantastic people. I could genuinely hear the sadness and the empathy in his voice regarding the cancellation of this trial. There was so much hope placed on this particular trial drug that I truly believe that it’s created a ripple effect through the entire Alzheimer’s and dementia community.

Being Patient: What exactly did they tell you the reason was that they canceled this late-stage trial?

Jeff Borghoff: We’re actually going in to meet with them this week to discuss the whole process. This is not really something you really talk about over the phone. However, from what I was able to glean from the various media outlets, it was that the drug itself wasn’t showing the statistical data to say that it was proving to be effective. I’m bewildered by that because for the last couple of years, we’ve heard nothing but positive results and positive reviews about this particular drug. As a matter of fact, one time the group told me that if there was any clinical trial drug that they would want to be on—these are the clinical trial folks—it would be Aducanumab.

Being Patient: Earlier, Kimberly had mentioned that she really did feel like this drug was working. What do you mean when you say you felt like it was helping?

Kimberly Borghoff: Younger-onset Alzheimer’s has a life expectancy of four to eight years. We are starting our fourth year, and my husband is progressing extremely slowly. When we first found out, my mind went right to, “Oh, my gosh. I’m only going to have him for a couple of years.” [I thought that] by the third year he wouldn’t even know who I was.

He’s still progressing, but very, very slowly. That, in addition to how he would feel after the infusions—I would ask him all the time, “Well, do you feel different?” We weren’t sure when he was in the blind study whether he was on the placebo or the regular medicine. And, I would try and measure out whether I thought he was on the medicine or wasn’t because we were all praying he was on the medicine the whole time. He would have these reactions, not bad reactions, but he would feel very foggy.

Jeff Borghoff: It’s very difficult to describe. You just get really tired. Normally, after an infusion, I would nap for a few hours or possibly the next day. The only time I felt like that was when I had an infusion.

Kimberly Borghoff: We were really thinking it’s the medicine that his progression was so slow. On the other hand, with him participating in this trial, it did take a toll on his body. It was a very long day for him. I work two jobs, but I always feel like I need to rush home after my second job. I knew on those infusion days, I didn’t need to rush home because he was already going to be in bed.

Usually, the following day, I knew he was pretty much out of it. He would have a car service come pick him up, drop him off. We go for MRIs at 6:30 in the morning, before I have to go to my first job, every two months. He gets PET scans. He gets all of this testing constantly, bloodwork. It’s a lot to be a participant in this.

Then, you’re sick. You have a fatal disease, and you’re still getting up and doing all of this month after month after month thinking that you could possibly be on the cure or, at least, Jeffrey would always say, “Well, I know I have five more years.” Because they said this drug he would be on it for five more years. That’s was our hope that for the next five years, at least we know that it was going to slow down the progression.

Being Patient: Jeff, take us through this past 36 months and how often were you there? What does it mean to be in a clinical trial from your perspective? It would seem like a lot of time, a lot of energy. Tell us exactly what it was like for the last three years.

Jeff Borghoff: Well, on the infusion day, we get up early. The car service takes me to the clinical trial center. They do your vitals. They take your blood. Treat you like a queen or a king, coffee, donuts, whatever you need. Depending on what the pharmaceutical company is requesting for that day, they may take a few vials of blood. They weigh you. Again, they take your vitals, etc.

You sit in a nice comfortable chair, and they give you the infusion, which lasts about 40 minutes to an hour. Sometimes they would take more blood. Then, afterward, the car service would take you home. Then I basically would rest for the next 18, 24 hours. That was once a month, but in between those times is when we would do all the MRIs. I think we did three PET scans in total over the last three years.

In addition to all of that, you have cognitive assessments along the way. The initial cognitive assessment that I did, which actually got me into the clinical trial, is on a point scoring system and it was up to 30 points. I think I scored a 28. If you score between a 26 and a 30, then that’s helpful for getting you into the trial. They ask you a series of questions. If anybody’s watching this and they’ve had this test done, it’s apple, table, penny. You have to remember those couple of words, repeat them back later, what did you do last week, things like time of day, where do you live, what state are you in, all of those questions.

During that process, I was continually scoring around a 26, I think. The last time we did this exam, I scored 100%, 30 out of 30. My wife thinks it’s because I’ve memorized all the answers.

Kimberly Borghoff: He was rehearsing the night before.

Jeff Borghoff: However, this is all about memory and if I’m in there taking a memory test and I score 30 out of 30 on a memory test, then my memory is actually pretty good.

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Being Patient: How much information are you getting back? Obviously, you have the results of the memory test, the cognitive testing. Do you know what the scans say? Do they give you any of that information? Now that they canceled the trial, have they told you if you’re taking a placebo or actually were taking the drug?

Jeff Borghoff: The first 18 months, you’re on the double-blind placebo-controlled study. After the 18 months, they move you right into what’s called the open-label. From 18 months to now, 36 months, I know that I’ve been on the drug.

The results of the PET scan and the results of the MRI are things that you never know about as well. However, the first PET scan that they took, they did tell us ’cause that’s actually what helped get me into the clinical trial. The first PET scan they did say that there were four areas of my brain where the beta-amyloid plaque was collecting.

Being Patient: The cancellation of the Biogen trials has thrown into the doubt the beta-amyloid hypothesis. Science is even confused and debates what the right direction is and what to tackle. What are your views on that?

Jeff Borghoff: Well, that’s a great question. It’s one that we’re wrestling with at this point. The condition itself is the beta-amyloid plaque, the tangles, and the build-up of the toxic tau protein. I’ve heard in recent months that the toxic tau protein is the worst of the three issues. I do know that the toxic tau protein is another clinical trial that’s actually being undertaken now as well.

Because it’s not just me who has Alzheimer’s, my entire family has Alzheimer’s.

We’re really wrestling with the whole clinical trial, going forward with any additional clinical trials for ourselves. It’s not just my decision, it’s a family decision. Because it’s not just me who has Alzheimer’s, my entire family has Alzheimer’s because everyone is so affected by it. Whatever I do, it really needs to be a family decision.

My inclination is that I want to continue on and try to go into any clinical trial that would have me that could possibly be a cure or preventative measure for this disease. However, I need to really be sensitive to what my family wants for me.

Kimberly Borghoff: We feel that he has given three years of his life and we only have him for a couple more years. We want him to do things that are going to take care of himself rather than running himself ragged and doing the whole trial. Jeffrey was on the most promising one, so the other trials out there are not even near where Biogen was supposed to be.

Jeff Borghoff: We’re going to talk to our clinical trial center about all of these things next week and the potential of additional trials. Kim and the rest of my family don’t want me to do any more trials, but I’m just the type of person where I just can’t quit. I just really need to try to help. I also need to be sensitive to my family’s wishes and what they desire as well.

Being Patient: What you’re so clearly are pointing out to us is really something that’s not talked about a lot, which is the emotional expenditure in participating in trials. It’s not just being a lab rat, so to speak, and getting these tests.

Kimberly Borghoff: The only way I could describe getting the news that it was stopped is heartbroken. I literally was heartbroken. It’s emotional. You’re constantly thinking. You’re constantly observing. I’m one that I need to know what’s going to happen next and by not knowing what this disease is happening because everyone progresses differently, I was holding on to him being on this trial and it was slowing it down. That was my hope.

Even for our children and my mother-in-law, who lives with us, it really ripped us all up last night and yesterday just trying to wrap our head around this. I went to work today and I called Jeffrey and I said, “How do you feel? Did it hit you yet?” He just said, “I’m so disappointed.”

I sincerely believe that the last three years of my life participating in this clinical trial, even as exhausting as it has been and emotional as it has been in that it was just abruptly canceled like that, I don’t feel like any of it’s in vain or it’s been a waste for me.

Jeff Borghoff: I think what’s important though, and I need to continue to remind myself of this, is that this is what it’s all about. This is research. This is why it’s called a trial. Because the research has been done and the hope is there that this will succeed in humans. That’s why they take it through these different phases. I sincerely believe that the last three years of my life participating in this clinical trial, even as exhausting as it has been and emotional as it has been in that it was just abruptly canceled like that, I don’t feel like any of it’s in vain or it’s been a waste for me.

My hope is that the information that has been gleaned from this clinical trial will ultimately serve the larger scientific community for research for a cure for this disease. I truly hope that nothing is going to go to waste or has gone to waste. Also, to whoever is listening right now, we cannot lose hope. We have to continue to seek enrollment in clinical trials because this truly, really is the only way that we’re going to find a cure for this disease is by people who are willing and able to participate, that they do try and enroll in these clinical trials. It truly is a must. Those people that do, they truly are heroes.

Nobody goes into this really thinking just about themselves. This is about generations of lives that need to be saved and to help eradicate this awful disease. I would say to people who are so heartbroken about this disease is not to lose hope and to continue to seek out clinical trials and to be hopeful that there is something else out there in the pipeline that will hopefully prove to be what we’re looking for.

Being Patient: Do you feel healthy?

Jeff Borghoff: I do. I know that exercise is extremely important, especially for brain and heart health. I’ve been working on that. You know what’s interesting? More often than not, I get people telling me or saying to me, “You don’t sound or look like you have Alzheimer’s,” which is a frequent thing you hear especially with someone like me who’s early-onset. However, it’s like my wife always says—spend 24 hours with me and you’ll see how I walk around in small circles sometimes.

Kimberly Borghoff: It always amazes me how my husband is able to get himself together for an interview or a talk because before this, he was out of it and we were telling him to just rest his brain so he could do this. After this, he will be out and probably have a difficult day tomorrow.

Being Patient: A viewer has just raised a really interesting point. He says, “What the heck happened to Right to Try? If Kim and Jeff think it’s helping, and it seems to me it is, let them continue if they want.” If you’ve been taking it for three years, why not longer?

Jeff Borghoff: I’m right there with that particular viewer. Honestly, I think that’s something that we will probably talk to our clinical trial folks on Tuesday about.

Being Patient: Both of you said you felt like the progression wasn’t as rapid on the drug, but what about your short-term memory? Did you notice that perhaps your short-term memory was still impacted by the disease or maybe not as bad?

Jeff Borghoff: Well, I think we know that Alzheimer’s attacks your hippocampus first, which is the processing unit of your short-term memory. In my case, it’s actually built up in areas of my brain that actually affect my speech and my cognitive, my multi-tasking and my personality.

I tell people that it’s really difficult to articulate to a person how I’m changing living with this disease. Because the organ that I use to measure that change is my brain. If my brain is changing, if it’s beginning to fail, how can I use that thing to make judgment calls about how I’m changing?

Kimberly Borghoff: You ask Jeffrey how he’s doing, he’ll tell you, “I’m doing great. Things are awesome.” Then, I’m like, “What?!”

Being Patient: What are your observations? ‘Cause they always say talk to the partner to find out how the person is really doing. What are your observations on that?

Kimberly Borghoff: That was part of the Biogen protocol. Every now and then, every couple of months, they would bring me in alone. Jeffrey would go in one room, I would go in another room, and they would talk to me about his progression. It was always very interesting because Jeffrey’s very positive, whereas I am a very direct person so I don’t sugarcoat things.

We would debate on how he’s progressing. Jeffrey’s cognitive ability is what has really gone. To make a cup of coffee, to make oatmeal, he really has to think about the different steps he’s doing. Two, his anxiety level is just increasing. His anger, his ability to deal with small tasks he could no longer do. So, he gets very frustrated at himself, which, in turn, comes out in anger.

He can’t control that and then afterward, he feels horrible. We’re at that point where it’s progressing and he knows it. I think it’s the worst part of it right now. I almost want to get to the point where he doesn’t know what is going on because then I would just have to deal with it instead of him also struggling with it.

For us to go to the park that’s right around the corner, we have to get in the car and drive there because he can’t cross the street with the cars coming. He gets too anxious. Going to the grocery store is a fiasco because he’s going off that way and every other way and I just want to get in and get what I need. He no longer comes to the store with me. Church, it’s too loud. There are too many people. We no longer go to church, we watch it on TV. There are so many little things, more than just the short-term memory.

Now, the short-term memory we deal with too. I’ll tell him tonight that tomorrow I have to do this, this, and this. Tomorrow morning, I’ll tell him, “OK, don’t forget. I have to do this, this, and this.” And, he’s texting me, “Where are you?” Then I just say, “It’s okay. I’m going here, here, and here.” It’s a daily thing of a lot of little things, not just one major issue right now. But that’s okay. We’re dealing with it. We are adapting. My mother-in-law, who lives with us, is absolutely fantastic with supporting us. We all realize, the kids and my mother-in-law, we all realize that Jeffry’s changing and we can’t get upset that he’s changing and try and tell him, “You’re doing it wrong. This is the way you should be doing it.” Instead, we are adapting to his changes.

Jeff Borghoff: And, a lot of times I see that and I express my appreciation for that to the family.

Being Patient: We talked earlier in this interview about how the news coverage has been about the company, about the share price falling, but I really want to talk about your voice and what your message is having been a participant for the past three years dedicating a lot of your time to this trial. What do you want to say to the pharma companies about the future?

Jeff Borghoff: I’m actually on a patient subcommittee with the National Institute of Health. That was actually brought up about how this information was actually disseminated around the world and patients found out about it from the financial networks. The efficacy of it just seems really askew.

This is not just about shareholders, this is not just about corporate bottom lines, this is about people’s lives. This is about the genuine hard work of clinical trial participants. We need a more ethical, personable way to receive this information, especially when you’re talking about your life.

If there’s any way going forward that the information from the biopharmas can be disseminated to the clinical trial centers first so that the patients can receive the information gracefully and compassionately, that would make a difference, I believe.

[ Next: ‘They Are Still Here, and They Can Still Contribute’: What He Learned From Alzheimer’s at Age 51 ]

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