The suspension of clinical drug trials for patients with high-risk breast cancer at two Dublin hospitals may have deprived some women of the chance to prolong their lives because they had no access to new medication, an oncologist has alleged in correspondence with the Tánaiste.
Earlier this month The Irish Times reported that Mary Harney had sought the Attorney General's advice on the trials' suspension by the Irish Medicines Board (IMB) at St Vincent's University Hospital and St Vincent's Private Hospital in Dublin three years ago.
She did this following representations by the trial's chief investigator, consultant oncologist Prof John Crown.
The Irish Times has now learned that the file sent to the Attorney General contains concerns raised by Prof Crown that women may have lost the chance to prolong their lives because they were denied access to a drug under examination which later proved highly successful.
One drug, herceptin, has been found to reduce by around half the chances of a patient developing a secondary breast cancer.
Prof Crown maintained in his correspondence that over 20 women who would have been eligible for the trial could not participate because of the suspension.
The proposed trials at both hospitals was part of a worldwide examination of herceptin and another drug taxotere. Other Irish hospitals participated.
Informed sources said that Prof Crown had sought an inquiry into the circumstances surrounding the decision by the IMB to suspend the clinical trial.
The suspension came shortly after Prof Crown alerted the IMB about financial issues involving the trial at St Vincent's Private Hospital.
The hospital had charged the VHI for the cost of drugs which the pharmaceutical industry had provided free of charge for trial participants.
The hospital subsequently reimbursed around €1 million to the VHI.
On foot of the notification from Prof Crown, the IMB sent inspectors 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 other doctors maintained that clinical trials at the private hospital had traditionally been covered by ethics approval from the committee in the public facility. Management disputed this. The IMB eventually ruled that the trials in St Vincent's Private Hospital did have ethics-committee approval. But the trials were suspended for several months.
