Saturday, October 11, 2008

the difference between genius and insanity is measured only by a cannula

G'day. I just got out of my very first drug trial and boy is my arm tired. I've always been interested in the world (money) of drug trials and thought I'd give it a shot. There's a place quite near my hospital/main classroom that does them; a few friends have gone and said they were legit so I decided to give it a go. The way these work is that some company (GlaxoSmithKline, Pfizer, etc) has some drug in some phase of development that they need to test. They pay this company, which has the facilities and staff for monitoring stuff, to do some sort of trial on the drug. Drug trials are broken down by phases. The Pre-clinical Phase is when they design the drug in the lab and then test it in vitro and on animals, at highly varied doses, to see if there are any serious adverse effects and if it works the way they want to. Next they move on to Phase 0, where they test very small amounts of the drug on very few people, to figure out a bit more how the drug is metabolized and what pharmacokinetics (the pathways of degeneration and activity of the drug in the body) are important to consider. Phase 1 tests the drug on a smallish amount of healthy people to see what the bioavailability (how much drug is in the body after 1hr, 2hrs, 1day, etc) is like and how the drug is metabolised, as well as any adverse reactions. Phase 2 is on a larger group of people and now, in addition to the aforementioed stuff, they will also check if it has any efficacy in the thing it's actually testing for (eg high blood pressure, diabetes, etc). Phase 3 is the ultimate one: a randomised and controlled trial on a large group of people with the disease/condition on whom efficacy is going to be tested - it is this Phase that helps bring home the bacon.
I was on a Phase 1 trial for a newly released generic version of exemestane. Trade name Aromasin, this drug has been around for like 20 years, as an anti-breast cancer drug in post-menopausal women. After 20 years, a drug company loses the patent on its drug and is forced to reveal the formula, so other companies can make their own versions, especially allowing for generics to be made. One of the reasons I was cool with this trial was because the drug has already been around for a while and this is for a generic version (which I whole-heartedly approve of); the others included that I only had to take 1 pill and the timing and money situation suited me. I had to go in from 7am yesterday (Sat) until 9am today (Sun) and then come in in the morning for the next 4 days. Then do all that again at the end of the month. This gets me $1030 tax-free*. This obviously sounds annoying but I'm actually happy for it since, as I mentioned, the place is near my school and I have a problem getting up early and getting study on, so this will force me to do so.
What was the thing actually like? I got there in the morning, after being told not to have any alcohol, chocolate, caffeine, or grapefruit juice the day before and not to have eaten since 9:30PM the night before, and got a cannula put in. This is access to my veins. We were given a light breakfast and then the drug (they did the thing where they checked under the tongue/in the cheek) and then had a small amount of blood withdrawn every 15 minutes for an hour, then every 30 minutes for 2 hours, then every hour for 3 hours, then 2 hrs later, then 4 hrs later, then 8hrs later in the morning before I left. This may sound annoying but actually is not a big deal at all - the amount of blood is minute enough so you don't feel it and you have nothing to do anyway. I was idealising the experience the whole time, "Wow, I'm getting paid to have a WHOLE day where I'm fed and don't have to do anything... I can study and catch up on internet stuff and watch stuff etc." Oh, how young and idealistic we are... Here's what I did: watched half of Jackie Brown, read more than half of Trust me I'm a (Junior) Doctor, watch 1 episode of Man vs Wild, 4 episodes of The Mighty Bouche, an hour each of Blood Diamond and The Hunt for the Red October, spent an hour reading recipes/looking at pictures on tastespotting, tried to understand what's going on in the economy, and did about 30 minutes of study. Yay. My eyes hurt from all that. I also took a bit of a nap and ate a lot. I was pretty hungry when I got there (having fasted the night before and cycled to the place) and then waited for like 2 hours to get a tiny breakfast. Then 4 hours until lunch - I was quite worried that I was being treated like a post-menopausal woman with regards to her dietary needs. But then we started getting a lot more food and I was happy. I was a bit surprised that we were eating hospital food (for that was whom was doing the catering) yet how not necessarily healthy it was. I had 2 big chunks of carrot cake, 1 lemon cake w/ cream, and 1 chocolate banana muffin, plus like 4 things of orange juice over the day. Talk about diabetic risk. As far as the actual drug goes, I didn't feel anything. I had a slight headache but I would much more easily chalk that up to confined space + air conditioning + fluorescent lighting + no exercise. The only weird thing was the crazy dream I had in the morning. In the dream, I was sleeping but semi-conscious and trying to wake myself up, but I literally couldn't do it. I heard nurses talking about me, saying that I was comatose and not knowing what they should do, and I was like in the mostly-asleep phase (in the dream, remember) and tried to tell them that I was okay and I remember literally shaking myself in order to wake myself up in the dream and then eventually woke myself up in real life. So weird. You know when you're on the cusp of sleep and you semi-dream but are still conscious (the so-called hypnagogic state)? That's what my dream felt like. Weird. If that happens next time, I'm chalking it up to the meds.
So that's that. The rest of my week was pretty decent. I started it by flying too close to the sun and subsequently getting burned. Monday I was in the library until midnight and then Tuesday I was in class/hospital/study from 8am-6pm with no real break. As a result, I was pretty ineffective the rest of the week. On Wednesday I went out to a fish and chips place for a friend's dinner. On Thursday a bunch of people met up for an evening/night BBQ at South Bank - the sweet park and artificial beach that sits on top of a river across from downtown. We sat around eating and drinking and then at 11pm went for a swim. It was so beautiful - we were the only ones there, a nice night, looking at the city, playing catch with a frisbee/nerf. I was talked into going out afterwards and so only got home at like 2:30 and then had to wake up at 7 for class. On Friday I got my head shorn in time for summer (which has been put on hiatus for the last couple days for whatever reason) and then went to a fancy annual lecture thing. Each year the school of medicine tries to get someone fancy pants to talk to us about their accomplishments, as well as dole out teaching prizes to best clinical teachers of the past years. This year the guy speaking was Graem Clark - the guy who invented the bionic ear (cochlear implant). His story was actually pretty impressive... he worked hard for about 30some years and as a trained doctor had to pretty much teach himself audiology and engineering and stuff. Also everyone else around him told him that it was impossible to do. And now over 100,000 people have the thing and they can hear. Pretty incredible. Afterwards there was free booze and food but because of my damn trial I could only stuff my face until 9:30 (10) and eschew all (1 glass) of alcohol.
Today the weather is pretty miserable and I feel a bit groggy. I must tutor later and then dumpster dive - who knows what treasures the dumpster will hold?
Jesus, I didn't know that!1
Yawning, I recently learned from an anatomy tutor, is to aid in pumping an extra oomph of blood back in to the center. The action of the yawn is caused by the lateral pterygoid muscle, and this contraction physcially induces force on the veins in the face, which helps pump blood back into the heart. Muscle-induced blood pumping is one of the main mechanisms that veins have of returning blood. The calf muscles are also useful for this, which is why when you do the full yawn/stretch thing, you also plantarflex (tippy-toes) your feet to return blood that's been pooling down there.
Last week was female sexual pathology stuff and we got to learn all about periods. This contained a very ample amount of information that I didn't know. Like how menopause can be like one long 6-month period, or that a lot of women get menorrhagia (increased amount/time of bleeding) and that this can be diagnosed by: longer than 7 days; greater than 80mls/cycle; changing pad less than every 3 hours; needing "double protection" (pad + tampon); loss of clots, etc. How do you know it's 80mls? Apparently some researchers spent time weighing/wringing out pads and tampons. For your own knowledge, 1 tampon is roughly equivalent to 5mls and 1 pad is about 10-15mls.
We also got to learn about the wide-world of contraception. It's amazing how much shit there is, and all for women, to prevent pregnancy. Pills and IUDs made of copper and rings and depot-shots and implanted pieces of rubber (which is definitely the one I'd go for). We also got a definitive answer on that oft-queried problem: is it cool to skip the sugar pills and keep taking the pill in order to "skip" a period? "Hells yah! Just try to have a bleed 4 times a year," is what they recommend. I was doing a bit of my own research into male contraception and found this thing, which seems awesome and I'd be willing to try out. There are other possiblities out there but, unfortunately, nothing that's really marketed well besides condoms and good ol' coitus interruptus.
Medical word of the post:
Pseudocyesis - the false belief that you are pregnant based on physical cues (no period, morning sickness, abdominal mass), despite evidence that you are not.

*I'm supposed to declare it myself

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