A VOLUNTEER who took part in a drug trial in Cork last week has described how he had to hold down the legs of one of his fellow volunteers while he had a seizure.
Philip Mulvihill, a 25-year-old student from St Luke’s in Cork, said that three volunteers had experienced seizures while eight others experienced milder reactions to Rimcazole, a drug which was being trialled for its potential use in the treatment of cancer at the Shandon Clinic in Cork city.
Mr Mulvihill said he and his fellow volunteers entered the Shandon clinic last Wednesday and were to remain at the clinic until this coming Thursday, September 2nd. He said they had been taken in on two previous occasions for a shorter time and a lower dosage but that there had been “no effect whatsoever”.
The longer trial was to test the drug in what Mr Mulvihill described as a “steady state” to see the effects of the drug when administered continuously. However, following a dose of the drug administered on Friday morning a number of the volunteers fell ill.
“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.
Mr Mulvihill, who was the only volunteer who did not have an adverse reaction to the dose, said other volunteers then began to complain of light-headedness, dizziness, nausea and muscle spasms.
“An hour after that the second volunteer was on his way to the bathroom, he collapsed and had a seizure and 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.”
The three volunteers who experienced seizures were brought to Cork University Hospital but were released over the weekend and returned to the clinic for observation along with the remaining volunteers. All 12 men were allowed to go home today.
Mr Mulvihill said some of the volunteers were “obviously shaken up” by the experience.
“We were informed of the risks in fairness but nobody expected anything like that, not even the doctors,” he said.
Mr Mulvihill said that clinic staff were “very good” in assisting those who fell ill and that the ambulances had reached the clinic within minutes.
Asked if he would volunteer for another trial Mr Mulvihill said: “I probably would yeah, to be honest. At the end of the day we need medical trials – without them there’d be no medicine.” He added that he was donating a portion of his fee to cancer research.
The volunteers received €2,100 in total for their participation in the trial, despite the fact it was abandoned as a precautionary measure by the clinic.
A spokesman for Modern Bioscience, a UK-based drug development company, confirmed yesterday they had initiated a study to investigate the safety of the drug Rimcazole in healthy volunteers.
Muiris Dowling, medical director of the Shandon Clinic which conducts research on behalf of other companies, said all 12 men were released from the clinic yesterday. He said all were well on leaving the clinic and would receive routine check-ups.
The Irish Medicines Board said a full investigation into the incident was under way but that it was too early to say when the investigation would be completed.