My senses were on full alert in the two weeks after my first infusion. I was hyper-attuned to my body, noticing every sniffle, every yawn, every ache and pain. If I sneezed, I immediately started thinking “side effect”. If my stomach hurt, I began composing an email to the team at the Diabetes Center about what my “terrifying new symptoms” were.
As the nurse who I worked with during the clinical trial eventually learned, I am a “sensitive” person in all things physical. My skin reacts, my body reacts… and god knows my blood pressure reacts. It was sort of the perfect storm: take one hypersensitive person who is also a chronic worrier who has also recently developed Type 1 Diabetes and was now participating in a PHASE TWO clinical trial, and you get… a full blown hypochondriac!
And yet, in spite of my insane vigilance towards even the most minute change in my body, there wasn’t much to notice. Given how quickly I tend to get a stomach ache when I’m anxious, or how red my skin gets when I’m nervous, or how high my blood pressure had gotten at the center just at the prospect of starting the trial, this was truly an amazing thing. I took it as the biggest clue that I had probably been given placebo, not drug – nothing in my system, nothing to react to, right?
And yet, deep, deep down, I had a suspicion that I was on drug. I felt it the way I imagine a pregnant woman ‘knows’ she’s having a boy (is that a thing? or is that just something I’ve read in books?). The same way this hypothetical beneficent woman smiles mysteriously, because she knows deep down in her bones that there’s a little penis growing in her belly, I knew, deep down, that it was an active chemical compound coursing through my bloodstream.
Even if I couldn’t feel it “kick”.
So I survived those first two weeks on uneasy footing – half positive nothing was going to happen, half expecting to keel over in the shower one day, never to be heard from again. In my free moments, I did constant “scans” of my body – was anything different? Was anything hurting? Sore? Achey? Was I getting a cold/fever/headache/flu? No, no, no, the answers kept coming back.
It was a pretty uneventful two weeks between my first and second infusion, given that I suddenly felt exponentially more significant.
Is that embarrassing? Believe it or not, the clinical trial did for me exactly what I was hoping it was going to do – it somehow, in its small little way, gave my disease purpose. My diagnosis, while still random, senseless, and excruciating, had at least been put to (semi) good use. I wasn’t deluding myself – I knew that, in the grand scheme of things, my participation in a clinical trial wasn’t going to cure diabetes or contribute that much to the fight. However. It was a small port in the storm. Half of me felt like nothing more than a walking science experiment, but the other half like a valuable piece of something.
Of course, that didn’t change the fact that as Infusion Date #2 (2 weeks later) began to approach, I started to get pretty nervous.
I’d already had over 750 mg of this drug/placebo pumped into my body and it was about to be doubled. Plus, was my body going to freak out again, spazzing and causing a blood pressure spike and generally humiliating me in front of an office full of medical workers?
The more I got nervous about it, the more I would be setting myself up to be nervous in the office – AKA the more I would be likely to have a blood pressure disaster. I tried to be cool with myself – to not think about it, but it got harder and harder as the date got closer. Finally, it had arrived, and I rode the (very long) subway ride to Infusion #2 in a state of what I hoped was “imposed chillness”.
And as we all know, imposing chillness on yourself always works. It’s really easy to tell yourself how to feel about things and then feel that way. That’s why everyone in the world always has such a good handle on their emotions 100% of the time.
I can’t remember exactly what my blood pressure was on Infusion Day 2, but it wasn’t awesome. Not as bad as the first time, but definitely above my normal. One of the more frustrating bits about the whole clinical trial experience is that, since then, I have had occasional issues of “white coat syndrome” in doctors offices – i.e., my blood pressure reading higher than normal because of nerves. Not an issue I ever had to deal with before. But, as is often the case with me, once something that involves anything as delicate as emotion becomes an issue once, it is destined to be an issue perpetually.
Fortunately, I was coddled into calming down once again, and before I knew it, I had 750 more mg of secukinumab – or placebo – pumped into my body. Just like that, Infusion #2 was over. And I hadn’t even needed to watch Ferris Bueller!
Convincing myself I was now a complete professional in all things trial, I traveled home and continued my day. I had a show opening the next week that I had a ton of work to do for and gave little thought to the infusion over the rest of the day. I had almost completely forgotten about it, actually, when I walked into the bathroom the next morning and caught a glimpse of myself absentmindedly scratching my neck in the mirror.
What was on my neck?
I pulled in for a closer look. There it was, unmistakeable: a long, thin, red rash that extended from just below my ear to my collarbone.
What. The. Heck.
I tried not to freak out. I tried to be cool – to impose chillness, as it were, but things had suddenly gotten pretty real. I was, at this point, pretty damn convinced that I had received drug, not placebo – I had been warned against a rash with the same frequency as I had been warned against infections; both were, as I understood it, major potential side effects of secukinumab. Sure, it was possible my incredible hypochondriachal qualities had somehow conjured a rash for myself, like a false pregnancy or something, but it felt pretty damn unlikely.
Was a rash anything to panic about? Should I be panicked?
Or, I allowed a small, a very small, part of me to hope – did this mean that I had gotten drug, and that the drug was maybe, like…working?
Could I possibly get more life out of my dying beta cells? Could this possibly help my diabetes?
I knew I had to contact the Diabetes Center to let them know about this symptom. Basically, if I got a splinter I had to let them know – they wanted to know everything that happened to me physically. I decided an email made me sound a lot less panicked than a phone call – because, at that point, I was still trying to be cool. (Ha Ha).
I sent an email to the nurse I’d been working with at 12:16 pm and 10 minutes later I had a response:
Call me when you get the chance. I am at my desk.
Hmm. Such a quick response made me a little nervous. But also, “when you get the chance” didn’t make it sound so urgent, did it? But also “I am at my desk” implied that she was sitting there, waiting for me to respond ASAP. Was the email so short because this was really bad news? SHOULD I BE FREAKING OUT RIGHT NOW?
I felt like a teenaged girl obsessing over the intricacies of her crush’s text messages. Except that, you know, I was a 27-year-old woman obsessing over the intricacies of her advising medical professional’s response to the revelation of a new symptom in a clinical trial. Same thing, basically.
I called. I answered a billion questions – when did this develop, how long, had I taken anything, any other symptoms, did I have a fever, what exactly did the rash look like, was it growing, how badly did it itch, did I have any others, could I check my whole body, what was my mother’s maiden name, what did I eat for breakfast on October 3, 1992.
It’s hard not to worry when you get that level of third degree on something you’re hoping is nothing. But it is, of course, just them doing their due diligence. Or so I told myself. Inside, I worried that on whatever notes page she was using, she was actually writing down HOLY CRAP ITS THE BEGINNING OF THE END. THIS CHICK IS SCREWED.
The nurse spoke with the doctor, she called me back, asked a few more questions, and then advised me to take a benedryl and let her know when the rash went away. NBD.
Honestly, I might have been disappointed if I hadn’t gotten a side effect. The rash, at least, seemed to be delivering on the macabre promise of the clinical trial – if I had just been pumped full of clear mystery liquid and not at least gotten some kind of worrying symptom it wouldn’t have been the full “clinical trial experience”. And frankly, it was an interesting development no matter what I was actually “on” – if I had been given study drug, this seemed to be proof of it. If I had been given placebo, I was frankly impressed with my body’s ability to manufacture a symptom seemingly out of nothing more than worry and blind conviction.
Our bodies are insane things.
Within a week, the rash had disappeared. I still had a week to go until my third (and last) “heavy dose” infusion – there would be monthly shots after that of a lower dose of secukinumab. In my mind, I was 2/3 of the way through the real challenge of it- being hooked up to an IV for a half hour while a huge dose of drug is drained into your system is a whole lot more intense than a shot once a month. And once the rash had resolved – really, that was within like, 6 days – I started to feel confident in my body’s ability to fight off whatever negative side effects I might get from this drug. If I was, indeed, “on drug”.
And if I was – again, I entertained this hope in the tiniest part of myself, I admitted it to no one, but inside I entertained it – what if the secukinumab was working?
With one week to go before Infusion #3, and the rash basically gone, I was feeling good as I took the subway to the opening of my show. Which is why it was so very upsetting to get off at my stop and discover I had a voicemail from the Diabetes Center.
And this one was not coming from the nurse or doctors I had worked with.
This one came from the Director – a doctor, but also, like, the head – of the Diabetes Center. A woman I had yet to meet – I was just a clinical trial participant; I had no need to meet someone that high up in the center. Why in the hell was she calling me?
Of course, because it’s a message from a doctor, it was disturbingly void of actual content. She introduced herself. She said she was calling me about the clinical trial. She told me to call her as soon as possible. On her cell phone.
Mind you, it was evening at this point. If the head of the center where you are committed to a clinical trial calls you after hours and tells you to call her as soon as possible on her cell phone, you’re probably going to worry.
If the head of the center where you are committed to a clinical trial calls you after hours and tells you to call her as soon as possible on her cell phone, AND YOURE ME, you’re probably going to panic.
I thought about my rash – what was wrong? Had she gotten word this was the first symptom in a deathly consequence of the drug? Maybe they’d learned the results of one of about a billion blood tests that I did with them – perhaps something much more significant was wrong. Blood tests can reveal about a billion different things that could be wrong with you – all ranging in severity from Scary to Majorly Scary. Which was I suffering?
I had missed her call by about 20 minutes (damn you subway!!), and I immediately called her back, no longer worrying about the fact that my hands were shaking. I was beyond deluding myself into pretending I could “impose chillness” anymore. I was scared. I waited as the phone rang.
She didn’t pick up.
What. The. Heck.
I left a message – I’ll call you back soon, call me back whenever, my phone is on all night, please just call, just call, just call.
I called her back 20 minutes later. Nothing.
You guys – why do doctors do this? When they tell us to call them back about something do they not realize how scared we are? How absolutely scary it is to hear that you have to call your doctor “as soon as possible”? Why do they not then make themselves accessible to ANSWER YOUR CALL BACK – or at least give you some hint of what the hell is going on in their messages (damn you HIPPA!)??
Meanwhile, my show was starting. So I couldn’t actually leave my phone on all night. I left it on for the next two hours, as long as I possibly could, then, when I was pretty convinced she wasn’t going to call me back that night, I reluctantly turned it off and attended the opening of my show. I was in a really good place to critically evaluate my theatrical work at that point, if you can imagine.
I didn’t actually speak to this doctor until she called me back THE NEXT MORNING. I had to endure one night of being pretty sure something was seriously wrong, of having my boyfriend reassure me that if it was actually an emergency, she would have called back that night- the fact that she didn’t meant I probably didn’t need to be that worried!
It didn’t matter that this made logical sense to me; what mattered was my fear and the fact that I was pretty convinced that something was wrong with me and I was about to learn exactly how bad it was.
Which is why, when I finally spoke to the doctor the next morning, what she did have to say came as a complete shock.
“We just heard from Novartis,” she told me, “And they’ve decided to cancel the trial.”
“It has nothing to do with the safety of the drug – they would legally have to tell us if it did – so please don’t worry about that.”
“Actually, it’s not completely clear why they’re canceling the trial.”
“They’ve told us very little. Just that they’ve decided to focus their resources elsewhere.”
“They seem to be shifting their priorities in funding Diabetes research, perhaps?”
“And it can’t be that they’ve noticed the drug isn’t working – because it’s way, way too early for them to have gotten any results.”
I finally thought of something to say. “Is this, like, uhm… something that happens a lot?” I asked her, sputtering like an idiot, “Drug companies just canceling trials?”
“I’ve worked here for decades, Jessie, and I almost never see this.”
I asked the next logical question. “So what happens to me?”
Nothing happens to me, dear reader. No more drug, no more trial. Effective immediately. I was to go in one more time to learn if I had been given study drug or placebo, then go in one final time in a few months to make sure, you know, I wasn’t really sick or like, dead, I guess, then I would be given a pat on my head and a lollypop and sent on my merry way.
Just kidding about the pat and the lollypop. Actually, the lollypop might have eased the blow a bit.
Because yeah, it was a blow. In case you couldn’t tell by my psychotic narrative, I was kind of emotionally invested in this trial. And now, out of nowhere, it was over? Because some multi billion dollar business had decided to “restructure”? Because some assholes in a conference room somewhere looked at graphs with dollar signs and realized it would be very easy to click a box marked “cancel” without considering the hundreds of hours already committed to this trial – and the work, my god, the work put in by the professionals at the Diabetes Center. This trial had been slated to be conducted at a hundred different locations throughout the country. And all 100 were now being told, “thanks but no thanks, we’ve changed our mind.”
And then there were the trial participants like me, who, frankly, weren’t even given a thank you for our participation, but were told “get out: we have no need for you anymore.” Novartis gave the Diabetes Center NOTHING to pass along to me. And I don’t mean compensation – I was being paid for the trial, that’s not what I was worried about – I mean like, a piece of paper saying “Sorry we screwed you over, Love, Novartis.”
I was told nothing. I still have no idea why they cancelled the trial besides that it had nothing to do with safety (because, as the director had told me, they would have been required by law to advise me of that), and that it had something to do with a “business decision.”
Does this narrative feel anticlimactic to you? Were you hoping for some interesting apex, wherein I survive the trial, or I learn if the drug did me any good, or I get sick and have to quit, or like…something satisfying?
I was hoping, at least, that the story of my clinical trial experience had a better ending than “Big Business Decides To Reallocate Resources, Jessie Gets Screwed.”
So now, I’ll never know if secukinumab would have made a difference in my system – and oh yes, they confirmed at my close out appointment that I was given study drug, NOT placebo. And the world will never know if there’s any value in biologics as an early intervention for Type 1 Diabetes. Plus, remember how I wrote, (stupidly, now, it seems) that doing the clinical trial felt good because it gave me back some kind of agency over a disease that had so completely wrenched control from me?
Novartis had now effectively screwed me over the exact same way diabetes had: by arbitrarily making a decision about what was going to happen to me that went against my wishes and was made without my input. What I had hoped would be an empowering antidote to the disempowering nature of diabetes turned out to simply magnify its effects. I felt five times as bad at the end of this clinical trial experience as I had before I started.
You guys, I’m not a moron. I know the chances of the drug making any difference to me were small. I know that businesses don’t care about individuals. I know that, in their eyes, they did just fine by me – when I signed on to the trial I signed on to whatever possibility they felt like throwing at me. Including canceling the trial.
But I’ve done a lot of research on this, and while trials are often cancelled, it’s almost always before participants receive any drug. It’s pretty rare to pull the plug after people have actually gotten the drug. And if the plug is pulled at that point, it’s usually for a pretty serious – read, safety – reason. Not an “allocation of resources” reason.
Novartis canceling the trial also effectively made me feel like an idiot. Were they not even curious as to whether this drug would have worked? Or were the chances of that happening actually so small that it was pretty easy to call it off? Like, they knew it wasn’t going to work; they didn’t need to wait to get results.
In which case, what did it say about me that I was willing to sign on to this?
This blog contains very few specific references to actual people or places. I don’t feel the need to broadcast the name of my hospital, or my doctors. They didn’t ask me to write about them, and it would feel invasive for me to do so. Even Dr. Smug deserves the benefit of anonymity.
But not Novartis. NOVARTIS cancelled my clinical trial, NOVARTIS screwed me over. I have so little agency in this whole episode that if all I can do is name them in this story to the few hundred of you who read this, I’ll take it.
Clinical trials can be pretty incredible things. They are responsible for some of the most significant advancements in medical science. It would have been nice to be a part of one. For now, however, I think it’s pretty safe to say that clinical trials are not for me.
Clearly, I get a bit too emotionally invested for the ride.
2 thoughts on “Living With Diabetes: The Clinical Trial (Part 3)”
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I’m so with you on those doctor voicemails- they could, at the very least, say something along the lines of “it’s not urgent” or “nothing to worry about” without violating HIPPA but perhaps calming the patient at the other end of the phone.
I’d also never really thought about clinical trials in the context you’ve placed them in, and I’m so glad to be reading about your experience. It makes perfect sense to me that you’d feel a sense of autonomy and even more, a sense of hope. I’m so sorry to hear about your frustrating experience and I just wish there was a better explanation they could give you!!
Can you tell I love reading your blog?! I’ve told so many people about it- including many patients with new diagnoses in the hospital I’m working in 🙂
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