Allegations are extremely serious

The protocols say research drugs must be supplied free of charge

‘Senator John Crown’s allegations about research practices at St Vincent’s Hospital are extremely serious. The distinguished consultant oncologist is unlikely to have made them without documentary evidence to back them up.’ Photograph: Brenda Fitzsimons

‘Senator John Crown’s allegations about research practices at St Vincent’s Hospital are extremely serious. The distinguished consultant oncologist is unlikely to have made them without documentary evidence to back them up.’ Photograph: Brenda Fitzsimons

Fri, Dec 20, 2013, 01:00

Senator John Crown’s allegations about research practices at St Vincent’s Hospital are extremely serious. The distinguished consultant oncologist is unlikely to have made them without documentary evidence to back them up.

His concerns centre around the modus operandi of clinical trials at the hospital, one of the largest in the State.

It is common practice to enrol Irish cancer patients in international trials of new treatments. Indeed it has been shown that people with tumours who undergo trials of a new treatment receive the best of clinical care and benefit from good outcomes.

These trials are carried out under strict EU protocols, with rigorous prior assessment of the proposed research by the Irish Medicines Board and the European Medicines Agency.

From an ethics perspective the protocols are clear: no clinical investigator is ever paid for the research work – it is carried out strictly on a pro-bono basis.

And because the drugs being administered to the patient are still undergoing testing and have yet to be formally approved by drugs regulators, they are supplied free of charge to the patient.

In practice, the drugs are supplied directly to a hospital pharmacy, usually with explicit liaison between a research pharmacist and the hospital pharmacist. They are clearly labelled as experimental drugs and are coded to preclude their involvement in any billing process.

The VHI’s unambiguous statement that it has been reimbursed by the hospital for any medication for which it erroneously claimed suggests St Vincent’s hospital has acknowledged its error.

Whether it informed authorities and whether appropriate investigations took place remains to be seen.

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