WOMEN who had breast cancer died after trials of a life-saving drug were suspended in St Vincent's private hospital, oncologist and Independent senator John Crown has claimed.
Prof Crown was speaking in the Seanad in the wake of allegations that the hospital engaged in financial fraud and and a cover-up after it wrongly charged the VHI €1m for the medicine which had been provided free as part of a drugs trial.
The trial, which involved testing the drug Herceptin on women with early stage breast cancer, was shut down for a year after the overpayment came to light in 2002.
"Women were denied access to a drug Herceptin, which we now know was lifesaving. Though it was not the intention of the fraudsters or those who attempted the cover-up, as an indirect result of their actions, women died," he said.
Prof Crown, who works in the public and private hospital in the St Vincent's campus said: "Herceptin is the brand name of a medicine called trastuzumab. It can stop the growth of breast cancer and sometimes reduce the size of the tumour."
The Irish Independent has learned that around 50 newly diagnosed patients attending St Vincent's would have been eligible for the trial in the time it was suspended and around 25 would have got the drug, with up to half of these benefiting.
He said that the private hospital had defended the wrongful charging of the VHI for the drug, provided free by the pharmaceutical company Roche, on the grounds it was not aware that the patients involved were part of research.
His hospital, its management and its board failed the women involved in the breast cancer drug treatment trials. "Justice must be done," he said.
Prof Crown told the Seanad that in September 2002, a member of the administration in St Vincent's private hospital alerted him and told him the hospital had been billing VHI and other insurers for drugs which had been provided for free.
"In the letter, he stated that this was inadvertent and invited me to join with the hospital in making a joint approach to the insurers," he said.
However, Prof Crown said other documents were provided to him which showed that this was untrue, that the billing was deliberate, and only ceased when the VHI found out. "Incidentally, they found out from me," he said.
Herceptin until then was only prescribed for late stage breast cancer but the new trials examined if women with early stage disease would benefit. Women in other major cancer centres were also involved in similar trials.
After the data from the various trials was analysed, the drug was also licensed for early stage breast cancer in 2005 and it was found to reduce the risk of the disease reoccurring.
VHI has confirmed it was informed about the wrongful billing by a patient and Prof Crown. It sent in PricewaterhouseCoopers and ended up getting a full refund.
The consultant told the Seanad that a large amount of public money -- probably tens or hundreds of thousands of euro -- was spent by a body in pursuit of a cover-up of financial fraud.
"And of course this was in St Vincent's hospital group 10 years ago, when a large amount of public money was spent trying to defend the absurd contention that the hospital wasn't aware that a very large research programme existed, as it was the only way they could justify a very substantial and deliberate misspending, misbilling, of money from the voluntary health insurers," he said.
A spokeswoman for the Irish Medicines Board, which oversees clinical drug trials, said it received a report of a "protocol violation" in 2002.
This led to the temporary suspension of recruitment of new patients to clinical trials at the hospital. Patients already involved in the trial continued to receive the treatments allocated to them under the trial schedule and it later restarted.
Responding to Prof Crown, the chairman of St Vincent's Healthcare Group, Prof Noel Whelan, said he already asked him to forward, as a matter of urgency, all information that he has in relation to the very serious allegations.
"Due to the gravity of the allegations that Senator Crown is now making, it is even more urgent that he supplies all information that he has in relation to his allegation," he said
The matters raised by Prof Crown relates to issues in 2002 at St Vincent's Private Hospital and it predates the establishment of St Vincent's Healthcare Group and the formation of the board of SVHG. If new evidence becomes available, the Board of St Vincent's Healthcare Group will take all appropriate action, the group stated.
Michael Brennan Deputy Political Editor