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[needles] Flourescent lights and tile floors. Sterile rooms and synchronized clocks. Televisions with nothing on them just for the noise, conversations with nothing to say for that same reason. Blood. Needles.
i've been here before. it's what i get paid for.
[45bpm] I'm in PPD. PPD stands for pharmaceutical product development. I'm sitting in a chair and using a procedure table for a desk in the procedure room. The signal is strongest here and I'm half-watching a guy in a brown shirt a couple years younger than me play super mario world on a Super Nintendo. He's good, makes it look fun.
A procedure room is a room in which blood is taken from healthy volunteers, which all of us are, to find out how the phase-one study drugs we're ingesting for money react to our system. In addition to taking blood, they also check vital signs and perform ECGs. ECG stands for electro-cardiogram and is every bit as fun as it sounds. For an ECG they attach plastic leads to eight key parts of your body, then attach wires to those eight parts. A button is pressed and within minutes a detailed map of your heart is drawn by a computer and printed out, added to a file full of information about your heart and your blood.
Blood is taken the same way blood is always taken. A woman or man who makes seven dollars an hour inserts a clean, unused needle into the center vein in your right or left arm and then inserts a tube into the needle and fills it with blood. It hurts at first, but after a while you get used to it. A while after that, if there are a lot of blood draws, it hurts again because the hole into which they've been injecting the needle begins to scar over and so they have to insert it through the scar tissue. This study has sixty-eight blood draws.
[so you're on vacation, right?] I'm here because they pay well, and I ain't too proud to get my money as a lab rat. The duration of the study is the next eight days, Wednesday morning through Thursday morning, followed by two weeks off. During those two weeks off, I'm required to appear twice for more needles and another ECG. At the end of the two weeks off I check back into the facility, this time for sixteen days. At the end of those sixteen days I have to come back for still more needles and another ECG.
For all of my trouble and bleeding they pay me four-thousand dollars. This is staggering money, and odds are if you're reading this you don't need me to tell you that. This is the fifth study I've done, for the most money. I made a little over a thousand dollars a month at my last day job, working forty hours a week every week. Four months of my life and I'd make this much money and it'd never end, working in a bookstore not the surest route to financial independence I've ever seen, and there's never enough time in life.
Every hour I spend when I am not in here, I have paid for with blood in a very literal sense. It puts in perspective the way you spend your time, when that time came at a tangible cost. In return for doing this I don't have to work a job. Part-time volunteers do these studies to pay off their car or the credit card bills they racked up when they were eighteen at an interest rate too-high, to fund one wild summer in Europe or their next semester at college. Professional volunteers do it because here's no way to make money that seems necessarily better, so why not this?
[the drugs] The drug I am testing is for HIV. No, they don't have to infect you with HIV to test it.
The way that clinical pharmaceutical research trials work are they go in phases mandated by the FDA. PPD is a phase-one clinic. Ever see those ads in the back of the alternative newsweekly or on Craigslist for do you suffer from insomnia/gastrointestinal problems/high blood pressure? Those are phase two-through-four clinics. Phase-one clinics test drugs for any variety of diseases, viruses, and ailments on healthy people who suffer from nothing of the sort. Got asthma? Not allowed in. Clinically depressed? Back to the soup lines or the night shift at the Waffle House, chief, or wait for a phase-two study for people who suffer from your particular ailment.
Phase-one studies are to test the drug on people who are healthy to determine what, specifically, the side-effects are. Each phase has several stages of its own. The drug I am testing has been tested for over a year on other healthy people; at this point we are taking it in combination with another anti-viral drug used to treat HIV to determine the side-effects of the possible drug cocktail. Because of the stage the testing is at, they can anticipate the side effects from what was reported by other people in the previous trials.
Phase two-through-four clinics are to determine whether or not the drugs work. This is the point at which the volunteers will need to have been diagnosed with the problem the drug is designed to treat. I've never done a study that wasn't phase-one; it's rare that the two overlap. People who qualify for later-phase testing rarely clear the screening process for phase-one studies. Studies pay volunteers at all levels, but phase-one studies pay the most. They're for the desperate.
[sounds like a party] The facility is divided into three neighborhoods, each of them with a hardly-noticeable theme to distinguish it from the others. We are in the city, clearly identified because, uh, the tile floor is in a pattern vaguely resembling a city street. The other two neighborhoods are the mountain and the beach. I feel somehow cheated, being stuck in the city, given the alternatives, but I couldn't tell you why. It ain't like any of us are gonna see the sunshine in the next hundred and sixty hours.
A hundred and sixty hours. It doesn't sound so long in those terms, until you start counting down to dinner because you're bored. Dinner is in two hours. A hundred and fifty-eight hours to go, from there.
Clinical drug research studies are not safe, but the health risks they pose have never been the primary concern I've had before volunteering. The number one enemy of the lab rat is boredom. Lock yourself in a room with fifty or so strangers for a week. Ya'll can watch TV. Having fun?
My group, the ones testing this particular HIV drug, are all dressed in dark brown t-shirts. This is to identify us against the other studies going on quickly and easily. There are twenty of us, but come tomorrow morning there will be only sixteen; four unlucky individuals who were assigned a letter, rather than a number, were selected as backup volunteers and will be sent home unless there are changes in the health of any of the other volunteers before the dose is given. I have been designated DJS-034. In truth, it's what I've always called myself in my heart. After the dose is given, any health changes are considered to be an adverse effect as a result of the study drug and reported. If the ae is very serious, the doctor can remove the subject from the study, who is sent home with full pay. This is rare, but it happens. Tony did a study last year that was cancelled shortly after dosing. The best one could hope for is a scandal of some sort involving the drug company to break mere hours after dosing, resulting in them cancelling all current studies to save face. It is a very strange life one leads when one finds oneself hoping for this, lighting imaginary candles and praying to imaginary deities.
The other group in the city is a group of forty volunteers. They are testing an HIV drug as well; the fact that none of them are suffering from obvious, visible side-effects is heartening. This is day fifteen of their study; they checked in on the first of June and shall be released on the last day of the month. They're making five-thousand dollars in exchange for not seeing by anything except flourescent light or breathing fresh air during the entire month of June 2005. They are wearing teal blue t-shirts.
By nature people in studies tend to gravitate first toward people in their own shirt color. The teal blues are an exception; having been in here so long, with so much longer still to go, they're bored and desperate for new people to talk to.
There is much more to say, but it'll be said later. The Super Nintendo is free.
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[hanging] Complication! Because of some boring nonsense with the last study I did, the study coordinator paged me over the intercom. djs-034, she intoned with a crisp, warm timbre to her voice, please come to the procedure room. I went.
[when your number isn't up] you've been moved to backup status, she informed me, because the study sponsor has not yet returned our phone call, verifying your approval for the study. Well, okay. What's that mean? It means that the study sponsor has to get in touch with her by eight o'clock in the morning. It means that, of the twenty of us who are here, sixteen of us are going to stay and four of us are going to be sent home in the morning, no drugs in our system and a check for seventy-five dollars for our time in the mail, and unless four of the twenty people who are here now have complications with their ECG, vital signs, or blood, I am going to be one of those sent home.
Yow! Sure puts a damper on things, doesn't it? I'll be left hanging till around eight o'clock in the morning, that promising four-thousand dollar check suddenly a whole lot less promising, wishing misfortune on all of my study compatriots. This is dirty business here, and I'm hoping someone takes a fall. Things have been tense the past few weeks, waiting for word, and unless I get the answer I need they're about to get a whole lot tenser.
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