March 2009 Word Count: 2000
Julian Munday
Guinea Pig
The world
of drug trials lit up on the public radar in 2006 with the infamous ‘Elephant
Man’ trial. The TGN1412 drug had passed all the safety tests and was granted
authorisation to be tested on human volunteers at Northwick Park Hospital,
London. But six men suffered horrible reactions to the drug: multiple organ
failure and grotesquely proportionate swelling to their heads and bodies. It
may seem mildly insane to volunteer for a drug trial in the wake of what
happened three years ago, but I wanted to explore the drug trial gold mine for
myself and figured one freak occurrence was exactly that. Of course, there is
always a risk of unpleasant, or serious side effects, but I was prepared to
take them.
I needed the
money too.
After an
initial registration procedure and a screening medical - to assess my fitness
and glowing health – I was accepted onto a week long trial to test a new
treatment for diabetes. The possible side effects in humans were unknown, but
animals had tolerated the drug well at high doses. I would be paid £1200 for my
time; I felt like a whore, and I suppose that’s what I was.
I arrived
at an anonymous building in Central London on a dark morning in February. I
was let into a minimally decorated reception via an intercom and an
electronically controlled lock. A smartly dressed security guard behind a large
desk and a surveillance camera watched from above. I thought about M15, Area 51
and all things top secret. After my bag was searched, I was allowed into the
inner sanctum where I expected to meet Mulder and Scully, or a mad scientist
with an evil laugh.
The ward,
which would be my home for the next week, looked like a high tech version of a
standard hospital. The room was fairly small and contained about ten beds
surrounded by an orchestra of beeping and blipping technology: heart monitors,
mobile electrocardiogram machines and other stuff that reminded me of robot
wars. There were three other volunteers on my particular trial: Neil, 25, an
Australian traveller, Edward, 37, a recruitment consultant, and lastly a South
African surfer called Pieter, 22. We were assigned beds and given white
wristbands to wear, reducing our identities - in the data world of research -
to numbers.
A guided tour of the building revealed a canteen, four lounges with televisions, a reading room and a games room complete with DVDs, a pool table and various other remedies for boredom. It reminded me of a youth hostel; apart from the barred windows, the CCTV cameras, and the intercoms barking instructions every few minutes. One of the most interesting remedies was seeing a tribe of cyber Rastafarians - volunteers with coloured electrodes hanging from their heads to measure brainwaves - playing the board game: Risk. Hmm …
“You will be fined £75, if you are caught using your mobile phone in the wards,” said senior nurse Dorothy Brown, in her motherly Jamaican accent. “Each time you are caught using it you will get a new fine, so if you don’t want to leave here in the red I suggest only using it in the permitted areas.” I can live with that, but my sense of humour didn’t measure up to the next part. “This is ‘day minus one’ and fairly easy. But you must stay in bed for 6 hours tomorrow on ‘day one,’ which is dosing day, and please do not close the curtains around your bed in the daytime, as we don’t want to find a dead person, ha ha.”
I took special
care to note down the locations of all fire exits.
After the ‘welcome’
speech I lost my hair. I figured Tom Jones would fall at this hurdle as I was forced to shave off all my chest hair with a blunt razor blade. A holter monitor - a Walkman
sized instrument used to monitor heart rhythms – needed to be attached to my chest.
This device would be connected to ten foam-backed metal buttons - effectively
super-glued to my chest – via ten wires. The guy next to me opted for ten
small rectangles to be shaved into his chest wig, but I went for the all over
bald look. We were to be connected to this device for the next 36 hours and we
were not allowed to shower.
Breakfast
consisted of tinned apricots, cereal, two slices of toast and an optional cup
of either decaf coffee or tea. I asked Neil why he decided to volunteer.
“I’ve got nothing better to do,” he said coolly, “ I’ve got a job on a cruise
ship sailing around the Caribbean next month, so I figured I’d do this trial
and then have a party on the money until I leave London.” Another man
(John) also from Australia had already been here for two weeks and had another
week to go; he was testing a new drug for anxiety and was looking forward to
his £2700 purse. ‘It’s a piece of cake, the dosing day is the tough one, but
after that the hardest thing to deal with is the confinement, he said
enthusiastically. “I’m off to New York then South America after this – I can
travel for ages with this money.” So the financial rewards are obvious, but I
was about to find out why the pay was so good.
Another
volunteer from Croatia mentioned a friend of his who volunteered for a steroids
trial recently and apparently gained almost two stones of muscle mass in three
weeks. He was paid £3000 and has probably joined the Olympic weightlifting
team. His was an extreme reaction to a new drug. So, the risks are real:
allergic reactions can and do happen, none more so than the TGN1412 case in
2006. The Medicines and Healthcare Products Regulatory Agency (MHRA), which
authorises hundreds of drug trials a year, said the reactions resulted from an ‘unexpected
biological effect.’ However, clinical trials in general have an excellent
safety record with hundreds being conducted each year in the U.K.
Recommendations were also implemented – after the TGN1412 case - to further
improve the safety of future drug trials.
‘Day One,’
was judgement day, otherwise known as dosing day – gulp. I was woken at
7:00am from a broken sleep and felt a tension in the air. Many nurses were
rushing around preparing syringes, checking machines and oxygen tanks. Another
wristband (red this time) was fitted and I was told from now on I must urinate
into a bottle; I couldn’t access the locked toilets without a nurse’s
permission. I was prepared for dosage; my weight was checked, blood samples were
taken, and blood pressure measured. I felt like a family turkey on Xmas eve:
thawed, stuffed and prodded with various things in preparation for a good
roasting. Though, this much attention was also perversely enjoyable.
If you have a
fear of needles then skip this paragraph; I struggled to write it actually,
with a 5-inch cannula attached to a vein in my right forearm. A cannula is
basically a valve, much like a beer tap, but instead of filling glasses full of
beer, it fills test-tubes with blood - my blood. A new drug needs to be
monitored when entering the body; consequently, blood is extracted (around 100
test-tubes in total) at regular intervals to observe the behaviour of the drug
in the bloodstream. The cannula is inserted into the vein using a very long and
menacing needle. When the needle finds a vein it is then removed – similar to a
rocket booster, after firing a shuttle into space - leaving a plastic tube
floating around inside your vein that is attached to the valve on the outside.
The result is an accessible supply of blood with minimal discomfort to the
patient, except when it’s being inserted that is. The alternative is to play
human pincushions and be pricked by syringes every fifteen minutes for ten
hours.
A new drug takes many years to develop. After testing the drug in animals, the MHRA authorises Phase One testing on human volunteers – basically the first time new drugs are given to humans. This particular drug was being tested for the first time on me, so I guess I felt the kind of pride that accompanies an astronaut, but also the fear that overtakes a ... well, a drug volunteer, I guess. Five minutes before the dosage and I am the centre of attention. There are three nurses, one doctor, a person representing the actual sponsor of the drug and somebody else with a clipboard. One of the nurses has a bottle of what appears to be frothy liquid in her hand. I feel scared; the contents of that bottle may contain my poison, or even my death, but part of me also feels that it is too late to let the side down; it isn’t of course – as a volunteer I am free to withdraw at any time.
On the wall the
red spots of the digital clock disappear and the countdown begins; my body is
wired to a heart monitor and I can see the pretty peaks my heart is drawing as
it beats at a cool 56bpm (pretty good in the circumstances). Wires cover my
body and the beer tap in my forearm is ready for happy hour. “Tip your
head back and drink it all.” The nurse opens the lid and hands me the bottle. I
put the bottle under my nose, but it is odourless. Jack Nicholson had it easy
in One Flew Over The Cuckoo’s Nest. This is real ‘medication time,’ Jack.
“Down the hatch baby.” I throw the mixture down my neck. I’m expecting the
worst and get ready for a foul taste, but it tastes oddly like cream soda.
After five minutes I haven’t shrunk, changed colour, or died. I am
told if something was to go wrong, then it would be within the first hour, so
the checks on me are intense: blood is taken every 15 minutes and the music
coming from my body via various machines is listened to carefully by nurses. After
an hour I felt relaxed and had complete confidence in the medical minds around
me. The hardest part was spending six hours stationary in bed. After the dosage
day it’s pretty much downhill (easy that is) unless you are taking part on a
longer trial with multiple doses. The rest of my week (medically) consisted of
two blood samples a day and urinating into a bottle, which can be frustrating
when one needs to go, but cannot open the toilet door. Overall the experience
was akin to having a week off: three meals a day, time to read and watch some
films and get paid for it. When I was released, I felt slight trepidation
stepping out into the cold air and noisy traffic of London.
There are
many reasons for not doing a drug trial: the unknown, the potential damage to
physical and mental health, the moral implications of helping pharmaceutical
giants, and the prostitution of ones’ body. One major reason for doing a drug
trial is money (unless you’ve an honest interest in the medical world).
Volunteering is a novel, fast, and statistically safe option to make few grand
in a time of financial gloom. If the money alone doesn’t convince you,
then maybe the perceived risks (to you) can be balanced with the possibility
that you’re saving the lives of potentially thousands of people dying from
disease.
Whether it is an apple, an acorn, or antibiotics, somebody has to put it in their mouth first.