Trials for life

In light of the significantly increased number of volunteer participants in drug trials recently, Colm MacEochagain weighs up the pros and cons of risking one’s health for moneyMaybe you suffer with asthma. Migraines. Depression. Or maybe you just took a few paracetamol last Saturday morning as you watched re-runs of Gray’s Anatomy, trying desperately to keep your breakfast down and piece together the fragments of the night before.Whatever the reason, chances are you have taken some form of medication, be it pills, powders, or drops, over the last seven days. And you’re not alone: recently published OECD figures reveal that Ireland’s per capita spend on pharmaceuticals, both prescribed and over-the-counter, is the third highest in the world. This is surpassed only by the US and Canada, and has tripled in real terms over the last decade alone. The insidious normalisation of pharmaceutical (ab)use, so apparent in North America, appears now to have reached our shores.One consequence of the intensification in demand for new drugs is the growth of a peripheral industry involved with the sourcing and managing of the healthy participants of Phase one trials.These trials are initial investigations used to determine the safety of drugs, and to determine the prevalence and extent of potential side effects from their use. They are typically undertaken in a clinical setting, where healthy volunteers are given a small dose of a drug, one which already underwent successful testing both in lab animals and in in-vitro cell culture studies. Relative to its population, Ireland’s involvement in clinical trials is extensive with an average of 390 trials underway at any one time.Dr. Morris Dowling, Director of Clinical Studies at the Shandon Clinic, a Cork-based private institution involved with Phase one trials, recently disclosed to the Cork Examiner that speculative applications by volunteers to participate in these trials had risen dramatically during the past two years of economic stagnation. He stated that it had become “significantly easier to fill the quota of volunteers for trials” since the recession began.It is also understood that a substantial majority of applicants to clinical trials are students. Gary Redmond of the USI described the situation as “extremely worrying” and expressed concern that “students are turning to clinical trials to fund their education because of a short-sighted move by our government in slashing maintenance grants while increasing registration fees”.Strictly speaking, remuneration of test subjects is limited to reimbursing whatever expenses the volunteer has incurred in order to take part, as well as a minimal supplementary payment, which is given in lieu of the participant’s time. In reality, however, most volunteers can expect to earn between €150-and-€200-a-day taking part in these trials. These payments are highly controversial as they are part of a scheme that has come under intense scrutiny in medical ethics circles in recent years by those who view such backdoor payments as an inappropriate incentive to volunteers participating in something that is inherently risky.They may have a point. Last summer, a Cork-based trial ended in controversy following the hospitalisation of three of its participants. Of twelve men participating in the trial, eleven suffered an adverse reaction to Rimcazole, a drug being tested for use in cancer patients.Speaking to The Irish Times, Philip Mulvihill, the only participant not to suffer a reaction to the drug, described how the other men began to suffer seizures shortly after receiving it. “I was in the bedroom and I heard a load of noise – one of the volunteers was after collapsing with a seizure while he was having his breakfast,” Mr Mulvihill said.  “About five minutes after that the guy in the bed opposite me started having a seizure. I actually had to hold his legs down – it was pretty frightening.”This case followed the well-publicised 2006 trials in London of TGF1412, a drug developed by German pharmaceutical giant TeGenero to help boost the immune systems of immunocompromised patients. Within minutes of undergoing infusion of the drug, however, the participants began to complain of a burning sensation, accompanied by severe pain and nausea. Within hours, all of the volunteers had been transferred to intensive care suffering the catastrophic symptoms of a ‘cytokine storm’ – the inappropriate activation of white ‘immune’ blood cells.Dr. Trevor Smart, head of Pharmacology at University College London, remarked that the men would likely “suffer long-term disruption to their immune systems,” and may face “a lifetime contracting cancers and all the various auto-immune diseases from lupus to MS, from rheumatoid arthritis to ME”. One of the participants has since developed “definite early signs of lymphoid malignancy,” according to Professor of Immunology at Nottingham University Hospital, Dr. Richard Powell.Although the majority of clinical trials proceed successfully and without incident, cases such as these highlight a need for more rigorous legislation in the area of clinical Phase one testing, particularly in regard to the timing between doses given to successive patients. It is also a worrying trend that many young people now appear so desperate for work, they would go as far as risking their health just to stay afloat.