Joe investigates

Finding volunteers willing to hand themselves to pharmaceutical companies for ‘first in human’ medical trials can be difficult. Many of Australia’s Irish immigrants, however, are just desperate enough to put their bodies on the line.

By Robert Carry

‘This is the first time GS-9411 has been administered in humans,’ reads the document Irishman ‘Mark’ is handed ahead of a clinical trial he has just signed up for in his newly adopted city of Melbourne. ‘There is a risk of death in first in human studies such as this.’

The money rumoured to be on offer for anyone willing to sign up for clinical trials carried out on humans in a string of clinics around Australia meant Mark was open to the idea of getting involved. However, with money tight and adverts from a firm called The Nucleus Network pitching for participants via an advertising campaign, he decided to make contact.

The Nucleus Network, an Australian clinical research organisation that carries out early phase clinical trials on behalf of pharmaceutical and biotechnology companies, operates out of two centres – one in Perham hospital in Melbourne and another in the Alfred Hospital in Heidelberg, just north of the city.

Money

“They ran a TV ad, advertising clinical trials,” recalls Mark. “They mentioned that you can get reimbursed. The ad also stressed that you’re helping millions throughout the world by helping to find cures, but my motivation was money. Simple.”

Mark got in touch with the Nucleus Network and after an over-the-phone pre-screening, he was emailed a timetable of upcoming trials he might be suitable for. “You look through them, for the ones that are the big money,” he says. “I applied for one that lasted 11 days and paid AUS$4,000.”

Next up was a two-hour screening. Potential candidates were prevented from drinking alcohol in the run-up to the battery of tests and can’t do any exercise for 14 hours prior to screening.

Mark soon realised that he wasn’t the only Irish person whose financial circumstances had forced them to step forward.

They are also given an extensive list of sometimes bizarre items which they are not permitted to consume. “You’re not allowed grapefruit juice or poppy seed and a number of other odd things, and then you’ve to fast for 10 hours,” recalls Mark.

Subjects then face blood tests, ECG checks, blood pressure tests and urine tests and, if they pass, they are given the green light.

Mark soon realised that he wasn’t the only Irish person whose financial circumstances had forced them to step forward. “I came across two others [Irish people] on the first trial,” recalls Mark. “There were 12 people on that trial so a quarter of them were Irish – and that’s not to say that more didn’t go for it but were not healthy enough.”

Funds

The Irish were not the only group resorting to the trails as a means of securing much needed funds:

“The guys that were in there for the trials that I was doing were overseas travellers and students,” says Mark. “It was nearly 50-50. As well as the Irish, there were also a lot of Indian people there. They don’t really care who it is, as long as they have a healthy participant. You’re only a number.”

With D-Day approaching, Mark was starting to have concerns. “It has a bit of a lab rat feel about it,” he remembers. “You get a bit apprehensive when you go through the consent form and read about it being a ‘first in humans’.”

Another factor was playing on his mind. On 14 March 2006, six men were rushed to Northwick Park Hospital in London after suffering severe adverse reactions to TGN1412, a type of antibody produced by German-based pharmaceutical company TeGenero AG.

One man, a previously healthy 21-year-old, was carted in while screaming in agony about how he thought his head was about to explode as it swelled to three times its normal size. One patient was in a coma for a month while others suffered heart, liver and kidney failure, septicaemia, pneumonia and dry gangrene. One lost part of his fingers and toes. All of them are expected to need treatment for the rest of their lives.

Human

Like Mark, these volunteers were part of a ‘first in human’ trial. “You think about that,” he says. “A lot of people who did the trials were very wary because of what happened in London.”

Mark was given the chance to sit down with one of the doctors working on the trial, which he hoped would put his mind at rest. “You can ask questions,” he points out. “If you’re happy, then you give your consent and go ahead. I asked one of the doctors, ‘Would you let your son do this trial?’ When she said yes, I was happy.”

It’s like playing Russian roulette, the more often you play, the more likely it is that you’re going to get that bullet.

With paper work signed off, it was time to get underway. Mark remembers: “When people see the doctors coming in and taking out their stuff, everyone gets a bit quiet.”

Mark and the other volunteers were told to breathe in through inhalers fitted with a solution containing GS-9411 – a potential cystic fibrosis treatment.

“We [the volunteers] were all in the same room, in beds. There were about 10 doctors all around the place. You have a canella in your arm and they collect a small amount of blood just before you start. Then they take more after five minutes, 10 minutes, half an hour, one hour and two hours.

“Between all of this they’re doing urine tests and ECGs every half hour. You’re lying there being constantly tested and having blood taken with it all being whisked off to the lab to be checked to see if anything is going on. It’s a military operation in there once they give you the drug.”

With the initial testing finished for the day, Mark had the chance to become acquainted with other aspects of the testing process. It was deemed necessary to restrict the salt intake of the volunteers which meant a tightly controlled diet for the duration of  his 11-day stay. “We were eating the driest of pastas and getting lettuce and carrot brown bread sandwiches with no butter. For some reason we were given 10 dried apricots after every meal – and you had to eat all of it – everything that’s put in front of you.”

Pain

Happily, Mark walked away free of the sort of side-effects suffered by the TGN1412 trailists, “I had the odd pain here and there, but nothing too alarming,” he says.

However, another male trailist Mark was later tested alongside discovered that his sperm turned yellow.

For his time and the risk to his health, Mark was paid the equivalent of €9 per hour.  However, he hasn’t been turned off by medical trials. “You’re allowed go back,” he points out. “People do it once, and then they’re normally not scared about going again, but that’s a false security. It’s like playing Russian roulette, the more often you play, the more likely it is that you’re going to get that bullet.”

Up to 75,000 Irish people are expected to leave our shores in 2011, all hoping that the lives they find in their adopted countries will be better than the ones they left. There should be no shortage of human lab rats this year.

Mark’s name has been changed to protect his identity.

JOE contacted The Nucleus Network for comment, but no response had been received by the time of publication.