Public domain image via Wikimedia Commons
A secure hospital ward, one Wednesday morning in March. When the doctor approaches with her trolley, I still have time to tell her no, that I’ve decided I’m afraid of drugs, that I don’t trust the pharmaceutical industry, that I don’t want the three comically oversized syringes of what might be 40mg of something called RPH-203, or might be a placebo consisting of saline and water, inserted into my abdomen.
RPH-203 is being tested for its potential to slow the progress of cancer-related bone lesions. I don’t have bone cancer. But I will be paid $1075 if I say nothing and submit myself to the mysterious, gleaming needles and, for the first and most likely last time, to the roulette of a paid clinical trial.
My consent form tells me that thirty-two healthy male participants have been enrolled and separated into four groups, and will either be assigned RPH-203 or a matching placebo. For medical science, this stage is an essential part of the road to approval for a new drug. The trial’s subjects are a broad spread: students, backpackers and unfunded artists. This cash injection will pay rent, supplement Centrelink payments, fund expensive art projects, or help pay for round-the-world trips. The feeling is that the risk is negligible. There’s a chance we won’t be dosed with an untested drug anyway, and we’ll merely end up with the placebo. According to my consent form, our assignment will be “random, similar to the toss of a coin.” It’s a coin toss whose result I’m not allowed to see: it is essential to the integrity of the study that the participants, doctors and support staff are kept in the dark as to who has been genuinely dosed.
The doctor is a slight, bubbly woman in her fifties. While her hands work at finding the optimum spot on my belly, she attempts to distract me.
“So, I bet you have a girlfriend,” she says in exactly the conspiratorial way you might talk to a seven-year-old.
“A wife,” I reply. I don’t mention that this wife of mine is dead set against my decision to supplement our meagre student incomes by loaning my body to medical science. Instead, I crane my neck and look for something to distract myself. The TV two beds down is set to a program in which a woman wearing a boxing glove repeatedly hit a clear plastic mannequin in the stomach. A readout at the bottom of the screen displays the force of her blows in imperial measurements: “Fist, 600 pounds.” “Elbow, 400 pounds.”
The needle digs hard into flesh and the doctor pushes down with two thumbs as I watch the dull thud of the boxing glove.
The process from there is simple enough. A cannula—a handy tap leading directly to my vein—is inserted into my arm. I lie flat in the bed and wait for reportable side effects, which will be recorded on a clipboard on the narrow wheeled table at the foot of my bed. I am not permitted to leave the ward for the next few days.
This much I know in advance: I will have blood taken sixteen times; I will stare at the roof a lot; my meals will be strictly controlled; I will watch a lot of movies on my laptop; the bathroom doors will be locked to prevent me urinating without taking a sample cup with me; and all personal interactions with the personnel will be conducted with the customary sterile, generic touch of a scientist monitoring specimens. When I am discharged, I’ll smell faintly of hospital-grade antiseptic for a few days, I’ll be asked to abstain from smoking cigarettes and drinking alcohol for a month, and I’ll return four times for further tests. The rest is left to chance.
My trial is formally known as a Phase I Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RPH-203 Following a Single Dose in Healthy Male Volunteers. I and the other healthy male volunteers are referred to, informally, as “R-Pharmers”.
All she knows is that she’s administering temporary pain and lasting uncertainty.
There’s a sharp intake of breath in the bed beside mine as the subject before me on the list is dosed. “Everyone’s gonna hate me today,” says the doctor. She has no way of knowing if she’s administering a new cancer-beating therapeutic cocktail or a placebo. She will never know who she is dosing and who belongs to the control group, and neither will I, and neither will any of the other test subjects on the ward. All she knows is that she’s administering temporary pain and lasting uncertainty. This is the psychic burden of the clinical trial doctor.
When she leaves, I find the bed remote behind my head and bring myself to a sitting position. I ask a passing nurse if it’s okay to sit up. “You can remain semi-recumbent, yes,” she responds unblinkingly.
I heard about clinical trials from an acquaintance, an aspiring independent filmmaker. It seemed that all he had to do was lie in a hospital bed and take unapproved drugs. In return he received enough money to live off and a little to put towards his films. There are different levels of trial, he told me, from simple blood donations to month-long stints of total quarantine. It’s extremely lucrative—at least for those used to having no money—depending on how far you’re willing to go.
Accounts of why people participate in these trials vary. A few actually claim they do it purely to assist with medical research. Many more do it for the cash. In a lot of cases, the quick, easy cash of medical trials provides a kind of unofficial arts funding. Artists, to make a rash generalisation, are not averse to either risk or drugs.
Obviously some people will do anything for money, and thus there is a risk that clinical trials will largely attract the unscrupulous. The screening process is accordingly rigorous.
I meet Tom at his house after a shift at his job. Tom is an actor, but to pay most of the bills he works a day job as a storeman in a warehouse for an infomercial company. He enrolled in his first clinical trial a year ago and he is quick to admit that he did that purely for the money as well.
“I was in-between jobs,” he explains. “I was doing some cash-in-hand work in a bar, which was sort of getting me through. Then my mate said he was going for this trial. My other mate was going to do it as well, so there was going to be three of us in there.”
He didn’t expect to be the only one to get accepted. One mate appeared to get cold feet, and the other was excluded due to a history of epilepsy. Only Tom remained.
Tom was dosed with an experimental drug that was being investigated for its potential treatment for ADHD. The drug was believed to have the capacity to correct the levels of chemicals such as norepinephrine and dopamine, the imbalance of which supposedly causes ADHD. In practical terms, this involved Tom living on a hospital ward for ten consecutive nights, taking four different doses of the experimental drug—this time, the consent form describes the dosage levels being selected “by chance, like pulling numbers from a hat”—and submitting to tests for any adverse side effects. There weren’t any.
“I just took a tablet, then they’d opened my mouth to check that I’d swallowed it,” Tom remembers. “And that was it. I mean, I got jabbed a bunch of times for blood samples, and I looked like a junkie. For probably a week after that I wore long-sleeved shirts.” Otherwise, Tom recalls, it was a simple and carefree time.
“I was in there with a lot of English and South American backpackers. We played FIFA tournaments on the PlayStation. I got fed, so I didn’t have to think about food. I got to relax. If you wanted to lay down and watch TV and do nothing, there was no one there saying ‘No, you can’t’. They had a pool table. I was working on a script. I was on my computer a lot, doing a lot of writing.”
Tom’s consent form listed possible side effects such as nausea, dizziness, anxiety, a sensation not unlike a head rush, and “disturbed thinking.” Tom experienced none of these. “From my recollection, they never made it out to be dangerous, because it was such a low dosage.”
So, I ask, you’re not generally scared of risk? “I’d say I wouldn’t be. I’m scared of heights. Heights scare the crap out of me. And I wouldn’t touch LSD again. But no.”
He went on. “After, my friends said, ‘Why are you doing that? You’re just being a guinea pig for a bit of money. Something could go wrong.’ But I don’t think that way. If it happens, it happens. It was meant to happen. Not fate or whatever, but just that it was supposed to happen that way.”
Tom thinks about that last statement, before adding: “Well that pretty much is fate, actually. But if you think in a positive way,” he concludes, “then good things can happen.”
He’d do it again, he concedes. “I could do another twelve-day one,” he theorises, “and get a big wad of cash. I wouldn’t have to worry about having a job for a little bit. I could just write and write and write… That’s a great idea.”
When I leave Tom’s house he is scribbling reminders in his diary: to enlist a co-writer, and to do another trial.
My screening involves a telephone interview, a full medical examination and a free pass to ask whatever questions I want. Eight days before the trial is due to start, I am emailed the details of my trial in a document which goes some way to filling me in on to what exactly I am exposing myself. I underline a few key phrases. “RPH-203,” it says, “is an experimental drug that is being investigated for its potential as a treatment for secondary cancer of the bone. It is believed that RPH-203 has the capacity to block the activation of a receptor in the body which triggers bone destruction.”
“There is a risk of death in first-in-human studies such as this study. You are encouraged to ask questions until you are sure that you fully understand the nature and requirements of the study.”
How serious really is the risk that I might die?
I plan to ask the following: does my previous aversion to drugs of almost any kind put me in a better, healthier position? Or does it mean I haven’t built up the requisite resistance, and this unapproved, untested cancer drug will hit me all the harder? Isn’t this trial a bit unethical? How serious really is the risk that I might die? Will I have to abstain from drinking caffeine for the whole period of the study, or just the inpatient part?
A few days later, in a tiny, windowless office, I get the opportunity to ask my questions. The screening doctor, a pleasant, beaming man who couldn’t yet be thirty, jovially introduces himself as Dr Matt. He pulls up a chair and faces me, hands clasped, and reassuringly confirms that I am not a guinea pig. “We’ve done four stages so far, and…” he flicks through the case history of RPH-203 and acclimatising himself with the finer points. “…everyone lived! Hahaha! So don’t worry.”
Despite this, Dr Matt urges me, if I have “any doubts at all” I should withdraw now. I keep at him for an hour, asking about short-term side effects—“nausea, cold sweats, aching”—and long-term effects. “No idea,” he says. I ask if this is a normal amount of questions. He smiles and tells me not to worry. Dr Matt reminds me more than a little of the teller at the bank who convinced me to open four separate bank accounts when I first moved to Melbourne.
This particular RPH-203 concoction is very similar to something that a rival pharmaceutical company already has on the market – they’re merely trying to emulate an existing drug. This puts them a step ahead. Nevertheless, there are side effects. Monkeys, Dr Matt tells me, had been dosed with more than ten times what I may or may not receive, and reports indicated an increase in liver enzymes, as well as reddening and bruising to the skin. The initial human studies have resulted in two people feeling quite nauseous, one “for about a month.” Dr Matt explains that if my (slightly lower) dosage yields similar results, the drug would likely be pulled from the trial circuit and reformulated.
Dr Matt then tells me a long and baffling story about a study several years ago for a different drug, presumably intended to instil in me a sense of trust in the company’s vigilance and duty of care. Several years after the testing of an undisclosed drug, he tells me, one bovine test subject began to show indications of loss of sight. All human volunteers for the study were recalled for eye tests. Some had left the country, and the tests had to be arranged for them overseas. There was a sense of urgency; the researchers were confident, but they needed to ensure that there was no lasting damage to the test subjects. The results came back and all showed nothing unusual. Dr Matt supports the theory the cow was probably heading towards blindness anyway, and her participation in that study was incidental.
Dr Matt stresses that my submission to experimental drugs is on a strictly voluntary basis. I am being paid for my time and inconvenience, not for lending my body to the study. The rate of inconvenience is roughly $12 an hour; my submission to experimental drugs is strictly voluntary. “The ethics committee are very clear on that one,” he says.
I’m taken to the ward where I’ll shortly be spending my three days and nights, and I’m prodded, tested, weighed and questioned about my health. I fill out forms. I get told off for leaving my shoes on while I’m lying on my bed having my blood pressure taken. The ward is a long, dark hospital room. The curtains around each bed are semi-drawn. The study that is taking place when I visit consists of a dozen or so young women, propped lazily in their beds, dressed as if for a quiet Sunday morning at home. Some look oddly peaky and I wonder about what side effects they might be suffering – but it could just be boredom stemming from the sheer quantity of Facebook and How I Met Your Mother being beamed from the laptops perched on their knees.
Dr Matt explains that this current study is a drug interaction investigation where volunteers are given a cocktail of new and existing drugs to see what happens. This one involves anti-depressants, says Dr Matt. “It’s quite lucrative,” he explains. “They stay in for fourteen days, so it can be about $4000. Backpackers love it.”
The technical part of my assessment is performed by a very young woman who identifies herself as a scientist. “But I’m working as a recruitment officer at the moment,” she adds. She takes a dozen blood samples from me, testing everything from iron to alcohol. She needs to jab needles in both arms due to my recalcitrant veins.
By the end of the day, medical professionals have determined that I am a healthy, clean and suitable male test subject.
Risk is perfectly natural. In this case, it’s an essential part of developing new drugs, and if anything, potentially throwing one’s life down in the name of science is “the driving force behind global capitalist development, a dynamic positive force for good, and a prerequisite to participation in a technologically based global era,” according to University of London sociologist David Denney. “Risk-taking reflects the undying and heroic quest to create wealth,” he continues. But though we are assured, in a way, through the confidence and professionalism of doctors, that we are in safe hands, does risk need also blind and perhaps misplaced trust?
“Modern air travel,” says Denney, “involves the danger of many tons of metal flying through the atmosphere at high altitudes carrying hundreds of people, powered by potential kerosene bombs. The risk lies in the remote possibility that, given the congruence of circumstances or human error, the machine may fall out of the sky, creating loss of life on a huge scale.” Yet we continue to fly.
Even acknowledging the value of risk-taking, there’s something inherently unsettling about a scientific process involving humans trying untested drugs being described as “random, similar to the toss of a coin.”
I google “clinical trial horror stories” to see what I’m getting myself into for my $1075.
Clinical trials acquired something of a bad reputation a few years ago, when one horror story was pored over by the press for its perfect combination of life-in-the-balance drama, science-gone-wrong wickedness and grotesque human deformity. It’s not difficult to find information about 2006’s “Elephant Man trials”, as they have been labelled. It was the first result when I google “clinical trial horror stories” to see what I’m getting myself into for my $1075.
The Elephant Man trials revolved around TGN1412, a drug designed to treat rheumatoid arthritis and leukaemia. When it was first introduced to humans in North London, it sent six people to the emergency room with organ failure and its development company, TeGenero Immuno Therapeutics, into insolvency. British tabloid The Daily Mail pieced together a timeline of the morning’s events:
At 6am the eight volunteers, all of whom were being paid £2000 for their trouble, were woken for routine tests. At 8:05am, “the horror began”. Six of the eight “strapping young men” began showing side effects that I imagine would be classified as “severe” on my consent form, including “shaking”, “writhing”, “vomiting”, “fainting, coming back to consciousness then fainting again”, and “hyperventilating”. One man became “puffed up like the Elephant Man”. Another’s head grew to “three times its normal size”, and his neck “wider than his head”. Another screamed out that his head was going to explode.
The six men dosed with TGN1412 were transferred to an intensive care unit. One of the two men dosed with the placebo, twenty-three-year-old IT consultant Raste Khan, appeared on BBC News to talk candidly about the trial, describing the men as “going down like dominoes”. The worst affected, twenty-year-old trainee plumber Ryan Wilson, eventually had to have all his toes and some fingers amputated. Problems such as all those listed above were just the short-term side effects. Within months of the trial, doctors predicted the men’s futures would include a variety of forms of cancer, lupus and chronic fatigue.
The dramatic outcome of the TGN1412 trial was said to be an unfortunate fluke – all protocols had been followed to the letter, and the dosage was 0.2% of what had been safely administered to animal subjects. A later report showed that while in animals the drug seemed to multiply T-cells—which researchers believed could alleviate symptoms of a number of conditions—the drug had the opposite effect in humans, inciting a “cytokine storm” and reducing their T-cell count to zero.
“Given the preclinical information,” said one researcher, figuratively scratching her head and shrugging, “it was the opposite of what we expected.” That might not be much comfort to the six men who suffered total system collapse within hours of taking their pills. And yet: everybody lived, and every one of those men got his £2000, and the medical profession learnt a lot about how to properly run a clinical trial and multiple lawsuits. Even in cases that ‘go bad’, risk still generates wealth.
This particular type of risk has, for some, become something of a steady income. In 2010, the Adelaide Advertiser reported on a twenty-year-old named Alex, who they described as a “serial volunteer” for the process. Alex estimated that for the eight–twelve studies (he can’t remember how many exactly) to which he’s subjected himself, he’d earned about $30, 000 to put towards his wind turbine business. “I do it solely for the money,” he said. Like Tom the actor, he spent his time in medical confinement working on projects.
This motif keeps recurring. The young entrepreneur, full of enthusiasm, lacking only cash, donates his or her body for a period of time in return for said cash.
It’s not hard to find them. It seems that everyone I know is only a few degrees separation from someone who has, at some point, made ends meet with cheques from medical trials.
This brings us to thirty-year-old clothing designer, and my friend’s housemate, James, who was also drawn to medical trials during times of financial need. A decade ago he was under pressure to pay unsubsidised university fees. “Medical trials appeared from the outside as an easy and quick-ish way to get some tax-free money,” James says. “I was focused on just getting it over and done with, getting the money and utilising it. It’s only really retrospectively I’ve considered, actually, that the concept of using yourself in that way, placing yourself in a hospital when you’re perfectly healthy, is a little screwed.”
James recalls his first trial as involving the testing of “some form of testosterone drug”. He was injected in his stomach six times a day for nearly two weeks. “That,” he says, “is a pretty fucked up thing to have to endure. I swore to myself that that was it.” A few years later, however, a need for money struck again, when he landed an internship in London and urgently needed to pay for his airfares. After that, never again.
Now, James is an established designer with his own clothing label. He is no longer as prone to bouts of poverty, and he’s developed strong scepticism about taking drugs for money. “Initially I would have said it wasn’t dangerous, but it’s hard to know what the long-term effects of the trials are. Sure, they do go on and on about the high level of safeguarding and pre-testing that goes into the drugs before they get to human tests,” he says. “And maybe immediately there are no real physical dangers. But I do have concerns for the long term effects of new drugs and the test practices on healthy individuals.”
Would he ever do one again? “Never,” he says. “I don’t think I’d recommend them either. It’s strange because the funds from my participation in them enabled me to undertake to pretty important stages in my life, so because of this I feel it was a positive experience. But the actual weeks in hospital were weird and a little sad. There’s definitely something kind of desperate about it. It leaves a bad taste in your mouth.”
I check into the ward on a Tuesday evening.
“Do you have any water with you?” they ask. “Food? Drugs? No sharps?” (Me: “What are sharps?” Them: “Sharps. Sharp objects. Do you have any?” Me: “Oh. No.”) “Have you consumed any alcohol in the last 48 hours? Drugs? No caffeine for 48 hours? No grapefruit products? Good. Please provide a urine sample.”
I walk to the bathroom, piss into the tiny plastic cup, carry it back to bed and hand it to a passing nurse. “Thanks,” she says. “You’re done. Dinner’s at eight.”
The atmosphere of the clinical trial ward has more in common with an awkward youth hostel than a hospital. There’s a common area that people are too ill-at-ease to use, including uncomfortably stiff couches, a pool table and a PlayStation attached to a wall-mounted TV. Mostly, people sit up in bed and scan their laptops noncommittally. Despite the shared space, it’s all very impersonal and solitary. We claim our meals by calling out our initials. Curtains remain half-drawn around the beds for most of my stay.
Several people in my cohort are conspicuous for being sent home early, having been deemed unfit for dosing. An ageing punk with long, greying hair, leather pants and a Buzzcocks t-shirt goes first. The kid one bed over from me, who can’t be any older than twenty, spends a few hours watching YouTube walkthroughs of Guitar Hero, his fingers twitching along involuntarily, before he is told that his blood tests have shown allergies of which he was previously unaware.
After my first dosage, blood its taken at regular intervals. I’m asked how I feel a lot. I feel fine, apart from what I suspect is a caffeine withdrawal headache. I have my laptop. I watch TV, flick through books and catch up on university work. It’s a strictly enforced opportunity to stay in bed and do some things I’ve been neglecting: I read a lot. I write a particularly dry university assignment. I watch Roman Polanski’s Repulsion (a film about a woman who loses her mind and finds herself unable to leave her apartment. Whole swathes of the film depict her lying in her bed, her eyes wide open. On reflection, it was a strange choice).
Across the ward, the five elderly men on a diabetes study frequently rile each other close to total revolution. “This is worse than watching paint dry, this place,” the red-faced, grey-moustachioed one chuckles. “It’s not the first time I’ve heard that,” replies the nurse as she takes a blood sample from his cannula.
The diabetes study inpatients have been afforded a greater degree of dietary freedom than us. They even get jellybeans. They agitate for tea and coffee. They are a tight-knit group, being on the same study, and at dinner times they sit around and converse about the things that men their age converse about – car parks, politics, oil pipelines, Chernobyl, Black Saturday, a potted history of the IRA, (the answer is always: “What you gotta remember is that most people are fuckin’ stupid”). They fantasise about the same foods. They daydream of escaping and going to the Formula One Grand Prix, which we can hear is happening, somewhere outside. “I’ll buy you a pie,” one says to another, “maybe a couple of cans of beer… If we were allowed out of this place.”
I assume their incarceration is as voluntary as mine, though because they’re all actually living with diabetes, they have the added incentive of actual, tangible health benefits. Regardless, the grumbling dissatisfaction continues into the evening until Dr Matt arrives to explain to them the limitations on their coffee allowance.
“I would argue,” says the one with the big moustache, “that in a real world situation people drink coffee. So not letting us have it means the study isn’t as accurate.”
“True,” says Dr Matt, “but we have two groups – one not allowed any caffeine or other stimulants. For the other we have eased the restrictions. We want to know what difference it makes.” The moustache is begrudgingly satisfied.
Dinner is a Tupperware container of overcooked penne Bolognese, a small green salad (with a separate sachet of dressing), an apple, and a chocolate frosted donut. We eat quickly. There seems to be an unspoken understanding around the table that expediency will disguise the odd flavourlessness of all hospital food. While we eat, I talk to two hardened veterans of the medical trial circuit: LB, a tanned, laddish backpacker from Norwich, England, and TS, a thirty-something disability support worker from Melbourne. (The trial ward’s privacy protocol states that “During your participation, you will be known by your subject number, initials, gender and date of birth.” I have disguised these participants’ identities accordingly.) Both are completely unperturbed by the risk.
LB shows me tiny twin scars on his belly where a thirteen-night study involved taking fat samples. He says it hurt like hell.
“I get the placebo,” says TS. “Every time.”
LB hopes that this won’t be his last trial. “Though I might have to beg,” he adds. “I only got on this one out of sympathy. The doctor said that my liver is fucked, that I should stop drinking so much. It’s a decade of partying, I guess.”
I tell them that I don’t think I’d do another trial after this one. I don’t like having my blood taken every hour. “It’s not that hard when they’ve got it on tap,” says LB, pointing to the cannula tube sticking out of his arm, flecked with dry blood.
On the third day we’re tentatively released back into the wild after being continually reminded to abstain from tobacco and alcohol for the next month, during which we will be returning for regular check-ups. Outside the hospital, I stand with TS and LB waiting for a tram. They both light up their first cigarettes in three days.
“I wouldn’t normally bother with one this short,” TS says, taking a long drag and blinking into the sunlight. “Three days. I usually do the week-long ones.”
As my fellow participants wash the hospital scent off with freshly burning tobacco, the slight chance that I might die for the $1075 I am earning is eclipsed by secondhand smoke and, well, the money itself.
A month later, when the trial finally comes to an end after all our outpatient check-ups, we get our money. The (notional) sanctions on alcohol, tobacco and grapefruit products are lifted. None of us have had any discernible side effects to report. A burden is lifted, as if the untested liquid in those gleaming needles loses all its theoretical potency the second we are issued our cheques. I safely cross items off the section of my mental list marked ‘short-term side effects’, having experienced no nausea, headaches, pains, bruising or shortness of breath. Despite whatever may or may not have been introduced to it, my body never lost control of its own affairs.
Later, I try to arrange an interview with someone from the ward – I have all kinds of questions. Do paid clinical trials lead to a kind of kind of guinea pig class? And given the uncertainty of the long-term effects of these drugs, wouldn’t this recurring pool of experimentees bring the unknown to each further study in which they enrol?
All attempts come to nothing. My calls are transferred, or never returned. Referral piles upon referral until I get it: no one is going to talk frankly with me. Even the media department doesn’t want to run the risk: they’re worried about coming off too candid, or too blasé. The weight of the situation could be lost in an interview. Talking to the press is too dangerous.
I do manage to find out that, a month after my trial, a two-day pharmaceutical conference is held at the Moscow Institute of Physics and Technology, and that after lunch on the first day of this conference, in a ‘mega-session’ titled ‘Russian innovative drugs and medical products’, the initial findings of the RPH-203 trials are presented. The facts and figures that came from mine and my cohort’s bodies are disseminated to a room full of scientists still digesting their lunch. By this time, my cheque for $1075 has long since been cashed and spent. I am left only with the vague lingering threat of blindness, sterility or death. The research cycle continues.
All names in this piece have been changed to protect participants’ identities.
This piece appears in The Lifted Brow #24: The Medicine Issue. Get your copy now.
Will Cox writes fiction and non-fiction about the absurd and the mundane, and edits at Casuals Network Press.