The amount of paperwork that goes into signing consent for a clinical trial is staggering, and quite frankly, enough to make even the most confident participant start to feel a little anxious. You’re literally writing your name to a multi-page document that says you acknowledge whatever the heck could happen to you, and heck yes, you’re OK with that.
But… can anyone actually be OK with that?
See, here’s the thing: I have always always always wanted to be more of a badass than I am. No surprise there – I assume most of us do. In my case, though, I harbor fantasies of being more reckless; the kind of person who would just take a car and “drive”, who might disappear for months on end without contacting anyone, who’d get a face tattoo without thinking twice.
Additionally, I entertain lengthy fantasies that revolve around me being less emotionally needy – I’ve always wanted to be one of those people who, when faced with bad news, retreats into themselves, becomes quiet and withdrawn. Instead, when I get bad news, I become a needy mess. I need people; I need to talk out my issues, I need to surround myself with those I love. There’s always been something sexy to me about that withdrawn rogue who I will never be – all “don’t worry about it; let’s not talk about it, I’m just gonna stand here and be strong.” In real life, though, I’m not that kind of strong. And, alas, never will be.
To me, that kind of strong goes along with the kind of person who would sign up for a clinical trial. The kind of person I was trying on in my “forget it, forget you, forget everyone, put whatever chemicals you want in my body, let’s see if this works because EFF diabetes.” The kind of person who ignored my dad’s advice to drop the trial, my mom’s pleas to drop the trial.
But the truth is, although anyone can “try on” a different personality, you never stop being yourself.
So although I’d signed up for the secukinumab study in a fluster of boldness, I was utterly terrified.
Logic only goes so far in something as personal and immediate as a clinical trial. As soon as I sent the consent forms back, I immediately consoled myself with all that useful logic I’d outlined from the last post – this was a drug that has been tried in people with psoriasis; standards for safety have to be pretty high in drugs that treat non-lethal conditions. I was at a great diabetes center; I was working with incredible doctors. Additionally, I’d gotten the OK to proceed from my endocrinologist. My boyfriend supported me too. As for my parents, although they weren’t thrilled (my mother especially), I reasoned that if they truly thought I was going to damage my health, they would have staged some sort of major intervention to try and get me to back down. Their relatively easy acquiescence to my doing the trial convinced me they thought that my decision, while the wrong one, wasn’t dangerous, per se.
But still, I was terrified. And somehow, the incredible process that marks the beginning of a clinical trial just served to make it scarier. Because, of course, it’s never as easy as show up and get injected with drug. Rather, there are pre-tests and pre-tests to determine if you’re even eligible for the trial. In my case, I had to have been diagnosed with diabetes within 90 days (check), it had to be type 1 diabetes (despite dozens of well-wishers and Dr. Smug’s “thoughts”, check), and I had to have enough function left in my pancreas that the secukinumab had something to preserve.
Remember, the trial was testing if secukinumab could keep some of my beta cells alive longer than the normal “honeymoon period”. It was determining if secukinumab could prevent the antibodies in my body from attacking my pancreas. But if my beta cells had all been destroyed already, there’d be no point in testing the drug, would there?
The first step(s) were blood tests. It had to be determined that I was healthy enough for the trial. You know, besides the diabetes – I couldn’t have any other major diseases. And, my god, I could not be pregnant. This is huge in clinical trials. The world of clinical trials classifies a certain type of participant as a “vulnerable population”, who requires an enormous amount of additional precautions before they can engage in a trial. People with mental illness, for one, would obviously be considered “vulnerable populations” in clinical trials – you want to make sure that their decisions to engage in the trials are actually their own, that they are being treated fairly, etc. I was entering this trial in the “normal” (non-vulnerable) population; were I to get pregnant during the trial I would immediately become a vulnerable population.
As someone in the study put it, if I were to get pregnant while taking secukinumab, they would be obligated to “follow the fetus for the first several years of its life” to make sure the drug had no impact on it. Woah. Every single visit to the diabetes center for the trial began with a pregnancy test.
Oh, here’s a general life tip: never, ever, ever, ever, EVER get any medical/diagnostic testing before going on vacation. One of my visits to the diabetes center for pre-trial bloodwork occurred a few days before I hopped on a plane to Aruba for my first ever post-diabetes-diagnosis vacation (that can be its own post). The first day of vacation, I got a call from the diabetes center that my CMP (Complete Metabolic Panel) had come back with some terrifying, atrocious numbers. Specifically, my potassium levels were off the charts – crazy, crazy high. For those of you unfamiliar with the minutia of CMPs, an ultra-high potassium level indicates that your kidneys are failing. The doctor who I spoke to from the diabetes center, upon hearing that I was able to engage in a conversation and, you know, not dead, told me he thought this horrifying number was probably the result of something called hemolysis – basically, lab error. Most likely, when my blood was flowing into the sample vial, the red blood cells had hit the side of the vial and broken prematurely; had hemolyzed, which was what caused the terrifying reading. But, you know, just in case that wasn’t what had happened, could I please get my ass to the nearest Aruban hospital as soon as possible to confirm that I wasn’t on my last breath with two failing kidneys?
Spoiler alert: it was hemolysis.
The major test I needed to undergo before I could be deemed eligible for the trial, though, was something called a glucose tolerance test. This is a big test in diagnosing diabetes – type 1 or 2 – and was meant to confirm for the trial that I was indeed a type 1, with enough beta cell function left to be useful for the test.
Remember c-peptide? (Dude. I feel like I start a lot of sentences on this blog with “remember c-peptide”). Anyway, c-peptide is that protein that your body produces when it produces insulin – by measuring it at any given time, your doctor knows how much insulin your body is producing at that moment. A glucose tolerance test is designed to measure your c-peptide level (and thus, your insulin production) over a period of a few hours, to see how your body responds when you eat something with glucose.
Basically, you go in to the doctor’s office fasting. They take some blood, to see how much insulin you’re producing when you’re fasting (not a ton for most people – and very, very little for a Type 1 diabetic). Then, you eat something with a pre-determined amount of carbohydrates, and they take your blood every half-hour from when you start to eat it to see exactly how much insulin your body produces in response to the carbs, and what your blood sugar does in response to the carbs.
As I mentioned, this is a big test for diagnosing Type 2 diabetes. Many type 2 diabetics, at least initially, have normal fasting blood sugar numbers, but when they eat something with carbs, their body might not quite respond normally. A healthy body would incorporate the carbs with only a minimal spike in blood sugar (the blood sugar of a non-diabetic rarely gets over 140). Someone with newly developing Type 2 diabetes might, in a glucose tolerance test, find that their body doesn’t quite “tolerate” the carbs as nicely – they might get a bigger blood sugar spike.
In my case, to prove that I was a Type 1 diabetic, I really needed to fail the glucose tolerance test.
And fail I did! I arrived at the diabetes center, got an IV put in, and proceeded to swallow a bottle full of Boost, a horrifying nutritional drink (silly me, hoping for a milkshake or a piece of cake…), and had blood drawn on the half hour for the next three hours. Of course, because the test needs to see what your body naturally does in response to carbohydrate, I drank the boost while taking no insulin to combat it.
Three hours later, my blood sugar had gone from 120 to 287 (that’s a glucose tolerance test fail if I’ve ever heard one!) and, as the blood draws would later reveal, my c-peptide levels remained grimly low the entire time. My fasting c-peptide came in at a measly .3 (remember it was .6 when I was diagnosed), and didn’t get much higher during the test. Meaning, my body did a pathetic job of making any insulin at all to counter the carbs. In fact, I learned later, that I barely produced enough c-peptide to even qualify for the study — I needed just that amount of function to even be eligible.
However, once I’d demonstrated that, yes, my pancreas is indeed broken, my kidneys are not failing, and no, for the 10,000,000th time, I am not pregnant, there wasn’t much left to do but start the study.
The secukinumab trial was set up to last 1 year: to start, I’d get three IV-infusions, 2 weeks apart each, of a high dose of the drug, followed by a monthly injection of a smaller dose until a year was up. The IV-infusions were the big ones — I was getting 10mg of drug per kilogram of body weight – given what I weighed at the time, that meant more than 750 mg of the drug.
In all those “deemed-safe” psoriasis trials, the most anyone got at one time was 300 mg.
This fact was not lost on me. True, there was a 50% chance that I was getting no more than saline in my body if I had been put on placebo, but there was also a 50% chance I was getting a higher dose of this drug than almost anyone had yet had in their body.
And so, it is an understatement to say that, on that day in May when I showed up at the diabetes center to get my first infusion, I was pretty terrified.
Everyone was so nice. And there were so many people there! The doctors and nurses that I had worked with previously, yes, but also a representative from the independent company that Novartis had hired to make sure that the trial was run appropriately. And the head of the diabetes center checked in to make sure things were going well. And then there was me, smiling and acting like the coolest customer there was, pretending that I hadn’t spent the previous night awake for hours, thinking back to that grim daydream of me on my deathbed six months from now, holding out my hand dramatically and gasping “If only…I hadn’t done… the trial…!”
You guys, I am so not a badass.
And I can pretend I am one in front of the kind doctors, pretend I don’t give a crap about whatever-the-heck chemical was about to be fused into my bloodstream, but there was a piece of this puzzle I had forgotten about: my body.
Unlike me, my body is incapable of lying. Which is why, when they checked my blood pressure before beginning the infusion, it came in at a whopping 155/110.
That is, bar none, the highest blood pressure reading I have ever gotten. In fact, my blood pressure tends to run low – I’m usually in the 110/60 range. The nurse who had been working with me was floored – what was this? I looked so calm! (It’s the acting background, I’m sure). There was no way they could give me drug with a blood pressure reading that high – instead, she gingerly asked if I wasn’t a bit nervous.
“No!” I insisted innocently.
Our gazes both drifted back to the machine: 155/110.
“Maybe a little?” I conceded.
So, the independent monitor, the doctors, the nurses…everyone had to hold up while your dear non-badass had to be handled with kid gloves to see if I could calm myself down enough to actually get the drug that day. I was mortified – and not just because I was wasting everyone’s time. I felt like my entire experience with this trial had been an exercise in pretending I was someone I wasn’t (see the beginning of this post). And yet, when it all came down to it, you can’t change who you really are.
You’re probably wondering why, if I was this torn up about it, I had let myself get this far in the trial. Why didn’t I just quit?? But the truth is, despite my incredible anxiety, I wanted to do it! I really, actually did! The main reason that I kept coming back to was that, stupidly, stupidly, it gave me a sense of purpose. It took my pointless, senseless, needless diagnosis and turned it into something that I could make even minorly useful. It made me feel like less of a burden, a drain, a waste. I was contributing something – something small, something that would probably get lost in the vast annals of diabetes research, but something nonetheless. It was, in its own small way, order within chaos.
And yet, on this day, with what seemed like the entire staff of the diabetes center bending over backwards to “calm me down”, I was feeling the opposite of purpose. I was, once again, feeling like a burden, a drain, a waste. And embarrassed – really, really embarrassed. Why couldn’t I just man up? Why was I so nervous?? It wasn’t that big of a deal.
The nurse, who is a wonderful, wonderful person/nurse, suggested I watch a movie. She popped in a DVD of Ferris Bueller (a good choice), and while that ran, I acknowledged to myself that since I’m me, the thing that would probably make me feel most better was the thing that always makes me feel better – talking. So, I talked. I became the opposite of the badass I wanted to be, monologuing to a relative stranger about my anxiety about this trial, the challenges of diabetes, blah blah blah blah blah blah.
And it worked. By the time Ferris got Sloane out of school, my blood pressure had settled not to my normal 110/60, but an acceptable 128/80. Confirming with me that this was, indeed, what I really wanted, without further ado the infusion began, and the small bag of “could-be-saline-could-be-secukinumab” began draining into my body.
It felt…like nothing. I left the center feeling vaguely ashamed by my body’s outburst, but with a kind of satisfying sense of “no going back now”. I had been told about the side effects to look out for – basically, if anything happened to me medically I had to let them know, but I was definitely looking for infections, fevers, rashes, etc.
However, I felt fine. It was done. It had begun.