It’s a big theme of this blog, much as it’s been a big theme of my life this past year.
The diabetes diagnosis wrenched control away from me and threatened never to give it back. Especially those first few months, I felt completely at the mercy of my disease. I thought about it constantly. I was never not thinking about it: even when I wasn’t testing my blood sugar, injecting insulin, measuring carbohydrates, learning how to give myself a foot exam, going to doctors’ appointments, reading up on diabetes care and management… even when I was just sitting down to eat or watch TV or riding the subway I was thinking about diabetes. It became my whole entire world.
I just logged in to my doctors’ online portal to check, and so far in 2014 I have had 32 doctors’ appointments. THIRTY TWO. And this is not counting all the times I have been in just for blood draws. Or the dentist appointments, or the recent workup stuff – the CT Scan, the ultrasound, the sonogram. (One day, if I can ever get this narrative to the present, I’ll go into all of that)
Additionally, my online portal is auto-reminding me that I have ELEVEN preventative care services to schedule. Among them: “Diabetes: Optho Exam”, “Diabetes: Dental Exam”, “Diabetes: Foot Exam”, and, my favorite: “Diabetes: Aspirin Therapy Consultation”, whatever the hell that is.
With my family, I talked about diabetes. With my boyfriend, I talked about diabetes. With my friends (when I could bring myself to see them), I talked about diabetes. Plus, in those first few months, with almost no glycemic control, and having to go through the learning curve of diabetes care, I was almost always sidelined, forced to call out of a social or professional engagement because I had just had a nasty low, or unable to go to dinner because I wasn’t sure if I was going to be able to navigate a menu.
Can we talk about what percent of our social engagements revolve around food these days? It’s just what we do – if you haven’t seen someone in a while, you ask them to dinner. You go out for brunch with friends. You grab lunch with your significant other. Food is IMPOSSIBLE to avoid, and yet, I so so badly wanted/needed to avoid it. Restaurants were unknown territory. My few experiments going to restaurants tended to result in huge spikes or lows as I measured carbohydrates wrong, especially at the very beginning of all this. And, let’s face it: the vast majority of restaurants don’t exactly serve “diabetes friendly” food. Sorry guys: vegan restaurants are not inherently diabetes friendly. Nor is fro-yo, or those crazy low fat donuts, or any other restaurant that you naturally in your head associate with “diet” or “healthy”.
I constantly felt like I had to choose between seeing people and maintaining glycemic control. “What do you care about more?” diabetes seemed to be asking me, “Your friends or your health?”
Of course, my friends were understanding. Of course, if I asked to see them in a non-food capacity, they did their best to adapt. But it doesn’t change the fact that, bar none, meals are the absolute easiest way to connect with people. And feeling like you’re the exception to a gigantic social norm is never fun. Watching people make special concessions for me was, in its own way, another example of just how much control I lost.
What, you ask, does this have to do with clinical trials? Well, everything. See, in those first few months, without even realizing I was consciously doing it, I began looking for ways to reassert control literally anywhere and everywhere I could. My decision to change my diet, for sure, came from there. And, ultimately, my decision to participate in a clinical trial came from there, too. However, before we jump into that, another quick game break.
DIABETES 106: Honeymooning
Of all the terms that have been coined surrounding diabetes, “honeymooning” is officially the most horrendous. Whoever came up with the idea of using this word (such a nice word!) to describe this state (not a “nice” state!) has a sick and stupid sense of humor.
As I’ve explained, Type 1 Diabetes develops because one day your immune system decides to start attacking and killing off the insulin-producing beta cells in your pancreas. However, the process, although it starts pretty instantaneously (and does plenty of damage right off the bat – consider: DKA), does take a bit of time to accomplish. While those obnoxious antibodies are doing their mischievous deed and attacking your beta cells, you often have a window of time – from a few months to up to a year – where your beta cells are clinging to life, and thus you still have some insulin production. It’s rare that all the beta cells will die at once.
Remember the c-peptide test I told you about? It’s OK if you don’t – this shit, as I’ve mentioned, is confusing. C-Peptide is a protein that doctors can measure the levels of in your blood. This is useful because c-peptide is produced by beta cells at the same time that they produce insulin. So based on how much c-peptide you have, doctors can tell how much of your own insulin you’re producing. As we know, Type 2 diabetics, initially at least, tend to produce a lot of insulin – their problem is insulin resistance, so their bodies compensate by overproducing insulin. Type 1s, however, because we are losing the ability to produce insulin, tend to have pretty low c-peptide numbers. Normal is .8 – 3.5. When I was admitted to the hospital, mine came in at .6. So, low, but not 0. That meant my body was still producing its own insulin – the beta cells weren’t all dead yet. As I mentioned, the killing process takes some time.
That “few months to a year” period after diagnosis, when many Type 1s will still be able to produce some (small) amount of their own insulin, is called “honeymooning.”
Although I didn’t know it at the time, this is a significant period, from a medical and scientific standpoint. As we learn more and more about diabetes, medicine is beginning to understand that the right interventions during the “honeymoon” period can have significant impact on the diabetic’s ultimate battle with the disease.
OK, back to the narrative.
Of everyone close to me, I think it’s fair to say my dad has taken my diagnosis the hardest. Honestly, he may have even taken it harder than me. Something about the way he’s built, his own experiences, and the way he processes bad news all worked together to make this news extremely, extremely hard for him to take. He also worked for many years in the pharmaceutical sector. Chronic disease, both in his personal and professional life, is something he’s had to be way closer to than anyone should have to be.
It was my dad who first found the clinical trial. Much like me, when confronted with this diagnosis, he responded with research – looking up anything and everything he could about diabetes. This led him to finding an incredibly good New York City-based Diabetes Center; one that is widely considered to be the strongest in the region. Although I wasn’t going to start seeing their doctors (hello: world’s best endocrinologist), he was interested in finding out if they had any relevant resources for me.
As it turned out, that center runs a ton of clinical trials for people with both Type 1 and Type 2 diabetes. Including, conveniently, one that was just about to start up for adult individuals who were newly diagnosed with Type 1 Diabetes. My dad, no doubt feeling overwhelmed by his lack of control over my diagnosis, suggested to me that I might look into it.
When the suggestion was first made, I hated it. I truly, fucking hated it. Hello — 32 doctor’s appointments in one year! Why in the hell would I willingly go see more doctors?? And to get random mystery drug injected into my system? Umm…what? No.It felt like the set up to a really maudlin TV drama – flash forward to me, a year from now, struggling for my last breath on a hospital bed, surrounded by my loved ones. “If only…I hadn’t done… the clinical trial!” I would sputter out, before I expired.
But I love my dad. A lot. And he was hurting bad – and, technically, as the one who got diabetes, it was my fault he was hurting. And if me learning more about this clinical trial would possibly take some of his hurt away – if he could see me being active and taking all steps to maximize my health in the wake of this diagnosis, maybe that would calm him down. A clinical trial felt like a bold move – but doesn’t fortune reward the bold? My dad is a bold man – he takes calculated risks and they often pay off. If he was liking this idea, it was certainly worth giving a look to.
So I called them. And I spoke to some wonderful, thoughtful, committed clinicians about this trial to see what the deal was.
The deal was this: Novartis, a pharmaceutical company, was launching a clinical trial of one of their new drugs, secukinumab, for people who had been diagnosed with Type 1 Diabetes in the last 90 days. The trial was to see if secukinumab, when administered in this key early time after diagnosis, could slow or halt the destruction of beta cells in the pancreas, thereby prolonging the “honeymoon period” and helping Type 1 Diabetics maintain greater control.
The good people at the diabetes center were completely, 100% transparent with me: there was no chance that secukinumab could reverse or “cure” my diabetes. And frankly, the chance of it arresting beta cell destruction wasn’t guaranteed by any means. But this drug had shown considerable promise with other autoimmune disorders and obviously there was enough potential in the idea for Novartis to decide to launch a clinical trial. Clinical trials are extremely, extremely expensive – Novartis wouldn’t have committed to this without some actual science backing it up. So, if I was interested, I should read over the consent form, talk about it with my family and loved ones, and of course, ask them any questions that I had.
So they sent me the consent form. And then, of course, I did what I do best: I researched.
First off: clinical trials. For those of you who are unfamiliar with how drug research happens in this country, here’s a quick explanation: the journey from hypothesis to FDA-approved drug takes a very, very long time. Years and years. Scientists think about what combination of chemicals and things they can cram together into a pill or serum to cure or treat specific conditions, then they research, research, research and test, test, test.
When things are still in hypothesis phase, most of that testing happens on animals. Sorry. For more of my thoughts on this, please check out Breakdown, my latest play with Murmuration Theater Company, in which I am writing ALL ABOUT these thorny animal-testing and other issues surrounding clinical trials. (Shameless plug!)
Anyway, once researchers have determined that a new drug formula has enough promise to move on to the next phase of research, they begin clinical trials. Clinical trials are rigorously controlled scientific experiments in which new drugs are tested on human beings to see if they work. They are divided into three “phases” – Phase 1 Clinical trials, Phase 2 Clinical trials, and Phase 3 Clinical trials.
Phase 1 is the very first level of human testing. Basically researchers are wanting to see if the drug has ANY potential at all. They are generally regarded as the riskiest and most dangerous type of trial – if you’re a participant, you’re among the first human beings to ever put this combination of chemicals in your body. To a certain extent, although it can be predictive, science never really knows what will happen when a human first takes a drug. Especially if no humans have ever taken it before.
Why would anyone do a Phase 1 clinical trial, you ask? Well, some drugs are so similar to other drugs, or judged to be so low-risk that people decide to go for it. In other (sadder) cases, the participants in Phase 1 clinical trials are often people with very few options. Extremely sick, terminal patients, for example, for whom all regular treatments have failed, may sign up for a Phase 1 clinical trial of an experimental drug as a kind of Hail Mary when there’s no other options. Otherwise, these people have no way to access any additional treatment.
If a drug “passes” Phase 1, i.e., is judged to have enough promise for more research, it moves on to Phase 2. Generally, Phase 2 is about figuring out dosing – researchers have determined that the drug has potential in doing what it’s supposed to do; now they want to see how much they can safely give patients without adverse side effects. Phase 2 is obviously a much safer phase to participate in than Phase 1 (you’re not the FIRST EVER PERSON to get the drug), but the focus is on efficacy secondarily, safety first. That means researchers want to make sure you don’t have side effects before they want to see if the drug “works”. If the drug “works”, too, that’s bonus.
If a drug “passes” Phase 2, it moves on to Phase 3, the final one. This is often where the researchers will open it up to many, many more participants. The primary focus here is effectiveness – does this really do what we want it to? If so, the drug “goes to the FDA” – that means, the researchers and drug company send all their findings to the Food and Drug Administration, who evaluate everything, all the research from all the trials, and ultimately decide whether or not the drug can be “released to the market”, i.e., legally sold.
It’s a very long, multi year process. The vast, vast majority of drugs never make it past Phase 1. Most drugs that do make it past Phase 1 will not make it past Phase 2. In fact, only about 5% of Phase 2 drugs will make it to Phase 3. And only a small proportion of Phase 3 drugs will ever actually make it to market.
I knew all this as I began my research into secukinumab. My dad told me – he was never trying to manipulate me into doing a clinical trial – he was merely looking for a way, I assume, to soothe his boundless grief and frustration over my diagnosis. I was never promised that doing a clinical trial would cure me, or that it would do any good at all. And yet, the more I researched, the more interested I became.
Secukinumab is a biologic – that’s a class of drugs that manipulates the immune system. So far, this made sense to me: my immune system is fucked, so a drug that messes with it would probably be the first place to go. And this drug had been researched already – just not in diabetics. Novartis had already, at the time of my research, taken secukinumab all the way through Phase 3 clinical trials for the treatment of … wait for it… psoriasis.
Wait, what? Psoriasis?
Actually, it’s not as crazy as you’d think. In case you’ve never heard of psoriasis (although you probably have), it’s a skin condition that causes irritation, flakiness, and redness – often in patches on the body. Believe it or not, psoriasis and Type 1 diabetes are not so different from one another – both are autoimmune conditions. Remember how I said that your immune system can pretty much confuse ANY healthy thing on your body for a foreign invader? (Alopecia – hair, Diabetes – beta cells…) In psoriasis, it’s having that same confusion, but with your skin.
So Novartis has already tested secukinumab for psoriasis, and apparently it’s been pretty miraculous. Right now there’s a few biologic drugs that people with moderate-to-severe psoriasis can use; if secukinumab makes it to market it could be a real competitor for the Enbrels of the world. At the time of my writing this, I believe secukinumab is “at FDA” awaiting approval for the treatment of psoriasis.
The more research I did, the more I felt like I understood what was going on: Novartis discovered this drug with incredible treatment of one autoimmune disease. Being as so many autoimmune diseases are so similar in mechanism, it naturally figured it would try its luck with other autoimmune disorders. The deeper I looked, the more I found signs of this – scattered internet evidence of clinical trials of secukinumab to treat MS, or rheumatoid arthritis, or Crohn’s disease.
Why not try it out in Type 1 Diabetes?
I find myself wondering what you’re thinking as you read this. I’m glad I can’t see your face – I’d be nervous if I could.
Are you tensing up, thinking oh my god, she didn’t actually do this clinical trial, did she? oh my god, she didn’t. Are you excited for me? Nervous? Thinking I am certifiably insane?
Honestly, I might be certifiably insane. But here’s the thing: clinical trials are huge, messy, crazy things. There’s potential for some very, very scary shit. But there’s also potential for some incredible stuff. Like, let’s talk about cancer for a second. For our entire lives, the foundation of cancer treatment has been chemotherapy – let’s blast these malignant cells with as much poison as we can; hopefully, we’ll kill them. The risks – of killing off and harming all the healthy stuff in your body – are worth taking, because there’s no other options available.
But maybe — cross your fingers, cross em! — maybe that’s not going to have to be the case forever. Recent progress in immunotherapy – truly, in a way, the opposite of chemotherapy – has been astounding. The basic premise is: instead of blasting your body with poison, hoping to kill off the cancer, why don’t we strengthen the body’s own immune system – give it as much of a boost as we possibly can – and hope that it can do the trick on its own. Recent clinical trials using immunotherapy to treat skin cancer have shown incredible promise. We might, truly, be on the brink of a whole new way to treat cancer. And yeah, testing on animals fucking sucks. And clinical trials have some serious pitfalls. But also: A WHOLE NEW WAY TO TREAT CANCER.
Now, obviously secukinumab is not gonna cure cancer. Nor can my experience compare, in any way, to that of a cancer patient. But sickness is sickness, and cures are cures. Only 2 months into having diabetes, I was already sick of being a passive “patient”. The more I thought about it, about what it would mean to willingly show up at a doctor’s office, welcome an unknown drug into my system (yeah, fuck you, immune system, take that), the more I liked it. It made me feel like a rogue, like a badass. It made me, most importantly, feel like I had forcibly grabbed some degree of control back. I was doing something. I was doing it. And while I didn’t necessarily think secukinumab was going to be “the answer” for Type 1 Diabetics, there was still something calming, something soothing, about feeling like I was using my senseless diagnosis for good – using it to do something productive, allowing it to make its own small contribution to the vast stockpile of knowledge that will, I bet, one day cure Type 1 diabetes.
It was, in its own stupid way, purpose. I wanted to do it.
Now, I am not an idiot. All this big picture bullshit was only worth considering if the immediate threat – potential side effects – was something I judged to be minimal. This was to be a double blind clinical trial, with 50% of participants receiving active drug, and 50% receiving placebo. That means, there was a 50/50 chance that I would be getting secukinumab at all – I might just be getting saline dressed up as a drug.
But, in the 50% chance that I did get drug, what were the side effects?
I did lots of research, lots. As you might imagine, most of the side effects of a drug that messes with your immune system involve immune system responses – you can get infections or fevers, or skin rashes. Things where your immune system, corrupted by the drug, would be unable to defend against regular invaders.
Well, infections and rashes are no fun, but they’re not the end of the world. The drug was, in my estimation, pretty low-risk. True, the long-term effects of biologics haven’t been studied too much (they simply haven’t been around that long), but I would be taking it for a year at most (that was to be the length of the trial), not for five years, or for life.
And I kept coming back to the psoriasis thing. This was a drug that had been successfully developed to treat psoriasis. Now, not to minimize the suffering of any of you with psoriasis, but it’s not a life-threatening condition. It is annoying and painful and embarrassing, but it does not threaten your life the way some other autoimmune conditions do. If a drug is being developed to treat psoriasis, it’s gotta be pretty safe. Otherwise, why would anyone use it? People with psoriasis can always opt to not take drugs to treat their condition – because they don’t technically “need” the drugs for survival, they can be selective about waiting for a drug that’s extremely safe. If it had been used on psoriasis patients, I judged it to be safe enough for me.
Plus… yes, I’ll admit it, there was a teeny, tiny part of me that quietly hoped it could actually work. If I was going to get a few months before my beta cells completely went kaput, wouldn’t it be a miracle if I could extend that period a bit? What if I never descended fully into “type 1 diabetes” and instead, thanks to this new magical drug, was able to maintain some of my own insulin production? It would give me a kind of “buffer” against the most dangerous stage of the disease – the stage where, with no insulin production at all, I would be 100% dependent on a chemical intervention to survive on a day to day basis. Maybe, just maybe, and yes, the chances were small – but maybe – this could really help me.
I was, in fact, moments away from signing the consent form and throwing caution to the wind (fuck you, take that immune system!), when my dad called. He, too, had been reading over the literature that I’d sent him on the trial.
“Jess,” he said, “I’ve been reading up on this, and I really don’t think you should do it.”
“Why?!” I asked, deflated, stunned.
“Did you see what Phase this is?”
Yeah, you guys… I’ve been holding off on that last critical fact: it was a Phase 2 trial. Not a “we’re pretty damn sure about this, it’s been tested in a lot of people, let’s just get our final facts” Phase 3 trial, but a “we dunno! Let’s see if it’s safe” Phase 2 trial. The much less safe Phase. The much less likely Phase.
Oy… once again I wonder what your face looks like as you read this. Were any of you on my side, rooting for me to jump in and take the mystery drug? I’ll hope for a few of you. I’m sure there are some for whom this entire idea is complete madness – my mother, for one, was so angry at my dad for putting the idea in my head that she let him feel her resentment for weeks. And hell, at this point even my Dad, who came up with the whole idea, had defected to the “don’t do it” camp.
But the truth was, it was my decision. And, phase 3 or phase 2, I was in.
Sorry Dad. I am truly your daughter – the idea, once caught, held. Fortune rewards the bold, and this was about as bold as I could imagine. My body had betrayed me, just solidly betrayed me; I wasn’t exactly feeling like I wanted to cherish and coddle it. Frankly, part of me wanted to punish it (this makes no logical sense, I know, I am my body…), or at least, to assault it with something.
Here’s the thing: I’ve spent a lot of my life reviling modern medicine in a theoretical sense with its sleekness and sterility. Long live the natural, I always thought. Let’s drink weird teas and eat good food and trust our bodies to heal themselves.
Well, my body can’t heal itself. Without the direct, daily intervention of sleek, sterile modern medicine, I would be dead. Maybe it was time to fuck the natural. Medicine had given me my life back. I wanted to ask it for a bit more. The worst case scenario seemed to be that I would be contributing to the fight, adding some knowledge to the pile.
So I signed the consent forms.
I was in.