Introduction – Day 0

June 26, 2006

I am participating in a clinical drug trial in Japan. Its a phase 1 trial for a drug that boosts haemoglobin levels in order to treat anaemia. The experiment is designed to determine ethnographic differences in the drug effects between Japanese nationals and caucasion or black subjects. So they need a whole bunch of gaijins. ‘Gaijin’ is the Japanese term for foriegner. Its pretty commonly used, so much so that us gaijins living in Japan refer to ourselves by that name, even though some say its a mildly offensive term.

The clinic needs gaijins who have flexible schedules, don’t mind being stuck with needles and have a reasonably strong or perhaps desperate need for cash. I fulfill all those criteria, except for the bit about not minding needles. In fact I hate them, but I went and ahead a volunteered anyway.

It wasn’t something I did without thinking. Phase 1 trials can be dangerous because they are the first time the drug is tested on humans; the next step after animal testing. The drug is given to healthy volunteers in small but increasing doses and the main area of study is how the drug is metabolised in the blood and excreted in urine. They are serious business and accidents do happen. In March of this year, 2006, in a clinic in London, 6 out of 8 subjects had major reactions during a Phase 1 drug trial. The drug was an anti-inflammatory, developed to treat leukemia patients. Within a few minutes of dosing all 6 feel ill, suffered organ failure and 2 fell into coma’s due to brain injury. As far as I know, these two guys are still in critical condition. The remaining 2 from the total 8 were given a placebo and suffered no reactions.

So particpating in a drug trial is not something to take lightly, but several factors convinced me. Firstly, the compensation money is very generous. Its not like I couldn’t do without it, but it will come in very useful, particulary as having recently moved to Japan my financial situation is unstable. Secondly, drug trials in Japan are more strictly controlled than in other countries. Like many other Japanese administrative bodies, the drug administration is beaurocratic and conservative. For example, while many Japanese drugs trials are technically Phase 1, they have often been passed into Phase 3 in the United States and many already have FDA approval. In order for it to be approved for sale in Japan, it must be proven that there are no adverse effects peculiar to Japanese physiology. So gaijins are used for comparison, as a scientific control.

I first heard about the clinic from an old friend, who told me about it when I enquired how he managed to live in Tokyo for so long with only semi-constant work. Not less than a week later, another friend told me about the same clinic, via a gooby guy he met in a night club in Roppongi. Roppongi is a notorious district in Tokyo famous for nightlife catering to westerners. Its probably the one place in Tokyo thats feels dodgy. You either love it or you hate it. I hate it.

A week after that, I hooked up with a guy I met on the internet to go spearfishing in Chiba and anyway it turned out he works at the clinic as an administrator/recruiter. It was enough synchronicity to convince me. I don’t like needles much but I’m not a pussy either so I volunteered and here I am.

But actually, my story doesn’t begin here and now. Its a bit more interesting than that, and starts several months ago when I first volunteered.

That was about 3 months ago. I volunteered for another trial, an anti-smoking drug. The clinic needed test subjects who smoked at least 10 cigarettes a day, but were otherwise healthy ^o^/-” ‘! I don’t smoke that much, but was happy to boost my addiction for a couple of weeks in exchange for about a little (or a lot of) cash. A whole bunch of interesting gaijins joined me, some gooby, some not, and we stood around chainsmoking on the balcony, telliing jokes and and rating the girls from the local catholic school as they walked past, as the doctors screened our blood and the nurses monitored our heartbeats with portable ECG packs. We wore these in a pouch looped around our shoulders, attached to electrodes on our chests, under hospital issue pajamas. The next step was the catheter (or canula) insertion, which is the reason why I prematurely left that trial and why I’m back here now on another trial, thankfully for even more money.

A catheter is a long slender needle that is inserted in and up your vein on your wrist. It attaches to a collection of valves that allow blood to be taken regurlary without futher needle puncturing. Most of these clinical trials require the drugs activity to be monitored in the blood, to determine its half-life, its effectiveness, how soon its washed out of the system etc. So the nurse take blood every couple of hours, sometimes every hour. The catheter helps simplify the process. Actually, the correct name for the device is canula, whereas a catheter is the name reserved for similar tubes that go up your whatsit. But in Japan, or at least in this clinic, the term used by doctors and staff was catheter. Maybe its a mistranslation, but its the term I’ll continue to use in this diary.

Closeup of a Catheter

When I had my catheter put in, it was about 5 in the morning. I had fasted since 7pm the night before, and I had been up all night playing Quake on my laptop. The catheter was inserted and I immediately noticed that the tube running out of my wrist was leaking blood, not freely, but up the tube towards the two way valve. Others had a little blood in their tubes also, but mine exceeded theirs and was increasing, maybe a a few millimeteres every minute. This is really nothing to worry about and quite normal until the pressure inside the tube stabalizes, but it was rattling me a little, so much so I started joking about it, which is never a good sign – forced hunour to alleviate fear. I joined some guys out on the balcony to have ciggie. I inhaled deeply on my clove ciggerate and, as the nicotine hit, my arms resting on the rough concrete ledge suddenly felt very frail. My vision began clouding into a deep green and I knew I was going to pass out. I’ve never passed out before, but I didn’t panic. I asked a friend, standing next to me and on the same trial, to hold my cigerette. I told him quietly I was going to faint, and sat down on a chair so I wouldn’t fall. I vague remember thinking that if I was spearfishing it would be a good time to release my weightbelt, but that might be have been after the fact.

I was told later that as soon as I passed out my head tilted back and I started snoring. But, later still, my friend said, in hindsight, that he didn’t think it was snoring, rather it was the sound of me choking on my own tongue. I choose not to believe him.

I woke up with a couple of nurses in front of me….

Daijobudeska?

“er….Hai…..daijobudes……I was just sleeping….no sorry, I mean I fainted…. thats weird….. I thought I was sleeping….”

I was fine, but they insisted I move into a wheelchair, the sudden movement causing me to throw up. Some puke went over my leg, some got on the wheel chair. They laid me down in bed and removed my catheter, and I thought ‘Fuck! I guess that means I’m off the trial!’ But anyway I was paid the reserve fee, which is pretty reasonable, but not the big bickies I was there for. But being mates with a dude here gave me another in – I just had to wait 3 months or so for the nurses to forget my face. Not hard, a dozen new gaijins pass through here every week, and besides we all look the same to them >_0

So anyway now I’m back, I’ve passed the screenings and so far the none of the nurses have recognised me. I’ve been poked, prodded, weighed, blood-pressured and my height has been measured. I’m lying in bed typing his and tomorrow at 5pm they put the catheter in again, so I better get some sleep.

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