Cancer drug trial ‘guinea pigs’ in hospital

TWO separate investigations have been launched after three young men were hospitalised yesterday after falling ill during cancer drug trials.

Cancer drug trial ‘guinea pigs’ in hospital

The three were part of a group of 12 men who volunteered as ‘guinea pigs’ for the drug trials, which got under way a few days ago at the private Shandon Clinic in Cork.

The trial in question was to test a drug on its potential use in the treatment of cancer. The trial, which was not due to be completed until Thursday, has since been terminated. As a precaution the nine other volunteers are to remain at the clinic under medical supervision.

One of the three men hospitalised had to be given oxygen as ambulances under Garda escort rushed them to Cork University Hospital (CUH) shortly after midday.

The men were being treated at CUH where their condition was described as stable. The Irish Medicines Board (IMB) and the Clinical Research Ethics Committee of the Cork Teaching Hospitals have launched separate investigations.

One eyewitness, who saw the men as they were taken away by ambulances, said there was a lot of commotion outside the clinic at the bottom of Shandon Street on the northside of Cork city.

“I saw two men in their 20s being taken out to the ambulances in wheelchairs, one of them was wearing an oxygen mask,” the eyewitness said.

Three HSE ambulances, two advanced paramedics and two rapid response vehicles all responded to the call from the Shandon Clinic.

According to medical director Dr Muiris Dowling, the clinic had already completed some testing of the particular drug and the reactions had not been expected.

“Three volunteers had an adverse reaction. They were treated at Shandon Clinic but were transferred to the Cork University Hospital as a precaution. Nine volunteers remain at the clinic. These are healthy volunteers with no previous medical problems,” said Dr Dowling.

According to the IMB, the Phase 1 trial in question was to determine the bio-availability of a drug for its potential use in the treatment of cancer, and there are no other ongoing trials in Ireland using the product.

As highlighted in an Irish Examiner report recently, there has been a surge in the number of people volunteering for clinical drug trials because of the recession and rising unemployment.

The Shandon Clinic, which is the country’s only contract research clinic, is receiving about 400 enquiries a month, with the majority of calls from people aged 21 to 25.

Just over half of those volunteering for clinical trials at the clinic are women. The vast majority are students from local colleges, who can expect to make up to €130 a day for tests on medicines which are not yet licensed for sale.

Clinical trials in Ireland are strictly monitored by the IMB and governed by European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.

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