Minister for Health Mary Harney has asked the Attorney General for advice and guidance on the issue of the suspension of clinical trials of drugs for patients with high-risk breast cancer at St Vincent's University Hospital and St Vincent's Private Hospital three years ago.
The chief investigator of the trial, consultant oncologist Prof John Crown, has made representations to the Minister about the suspension of the trials at the hospital by the State regulatory body, the Irish Medicines Board, in autumn 2002.
The results of the trials, which have emerged in recent months, have shown the drugs involved to have been particularly successful for patients. It is understood that Prof Crown has argued that the suspension resulted in patients with breast cancer being denied access to potentially life-saving medication.
The suspension of the trials came shortly after Prof Crown alerted the Irish Medicines Board about financial issues involving the trial at St Vincent's Private Hospital.
The hospital had charged health insurance companies for the cost of drugs which had been provided free by the pharmaceutical industry for patients who were to participate in the trial.
The hospital subsequently reimbursed a substantial sum of money, believed to be around €1 million, to the insurance companies.
On foot of the notification from Prof Crown, the Irish Medicines Board sent an inspection team to St Vincent's to examine the trial. It is understood that the team discovered some problems regarding the reporting of adverse reaction to drugs and patient-processing issues, as well as the financial matters.
Around the same time a dispute erupted between management at St Vincent's University Hospital and Prof Crown over whether approval for trials granted by the ethics committee at the public hospital extended to the nearby private facility.
Prof Crown and a number of other doctors maintained that clinical trials carried out at the St Vincent's Private Hospital had traditionally been covered by ethics approval from the committee in the public facility.
However, management at St Vincent's University Hospital disputed that its ethics committee could extend approval to the private facility. Under legislation, all clinical trials on drugs carried out in Ireland must be covered by approval from a hospital ethics committee.
The Irish Medicines Board eventually ruled that the trials in St Vincent's Private Hospital did have ethics committee approval.
However, the trials involving the drugs taxotere and herceptin for breast cancer remained suspended for several months and patients at St Vincent's private and public hospitals could not be enrolled.
Patients with breast cancer at St James's Hospital did participate in the trial.
A spokesman for the Minister said last night that Ms Harney had received a letter from Prof Crown and had decided to ask the Attorney General, Rory Brady, for his advice and views on the matters raised in the correspondence. Prof Crown said last night that he welcomed the intervention of Ms Harney.
St Vincent's University Hospital and the Irish Medicines Board last night declined to comment on the Minister's move.
