Trials and tribulations

Just like the part-time bar job, the summer shifts in the factory or the weekend retail work - taking part in clinical trials has become an established source of student income. 19-year-old student David O’ Donnell has taken part in many such trials and around about now was due to take part in a high dose trial of a drug currently only known as TGN1412.

His trial was cancelled after six men who had been given smaller doses of the same drug were taken ill.
One of the men who were said to be in a ‘serious condition’ in the hospital was a friend of his, O’Donnell told the BBC that as he was ‘partly responsible’ for letting his friend know about the financial benefits of the trial, he felt a certain amount of ‘irrational guilt’. The first year economics student at university in Birmingham said that as someone who has done a number of different drugs trials, he was ‘very shocked’ when he heard how the subjects had reacted to the drug. The 19-year-old said many students took part in the trials because of the large sums of money involved.
He added: “Being a student, it is very difficult to find flexible employment. Clinical trials allow us to earn large sums of money in a small amount of time.”
The fee for the trial in question, he said, was the equivalent of a student loan and would make a real difference to a student’s life.
Most parties would suggest that this much publicised case at London’s Northwick Park Hospital was indeed a ‘freak accident’, and David O’Donnell maintains his confidence in the system. While the efficacy of animal testing is thrown further into question, we should expect to be increasingly reliant on healthy volunteers to aid our quest for medical advancement.
The study, called a phase 1 trial, looks at the safety and tolerability of the product, allowing scientists to find side effects in a small group of patients. Regulators require larger studies of people who have an illness to determine a drug’s dosing level, efficacy and safety. It is true to say that society owes a lot to the students through history who have leant themselves for medical research, although many of the earlier volunteers weren’t enticed with such wealth, but the world is changing fast and capitalism doesn’t leave a single stone un-turned.
Fifteen years ago much of the drug-industry sponsored studies were run by academic centres, today the majority of drug-maker’s trials are conducted by for-profit companies, such as Parexel. Similarly, trial participants are now far less frequently obtained through a volunteer list at the local hospital; instead a growing number of people with varied claims of worthiness are offering themselves as volunteer agents. Everybody wants to make some money from this, so who’s going to make sure you’re looked after?
There are good measures in place to ensure safety, but the volunteer accounts coming out of the trials at Northwick Park Hospital are nothing but chilling. Participants were told that failure to participate correctly in the study would directly affect their pay placing added weight to the daunting scenario, especially if you’re only there for the money. When you are dealing with thousands of pounds; that suddenly becomes a lot of power.
With companies like that, you’re almost certainly going to need an agency, but choose wisely. Also ensure you fully understand what your trial entails, do not let them rush you through any explanations - you are entitled to gain an ‘appropriate understanding’ of what you are about to participate in.
Healthy volunteers for clinical trials form an integral part of the drug development process, comparable to giving blood, it is a great charitable act. The financial benefit should not be considered a fee, in many cases it could simply be expenses. The payment is a reimbursement for your time, you yourself, and the risk you have undertaken. Whether it is a sleep study or an anal probe, consider the consequences. Above all, don’t expect or even try to make a living from clinical trials; they won’t help you get rich quick and that’s not what they are there for.

Comment by Lucy Scott