Co Down doctor admits falsifying clinical trials

Dr Hugh McGoldrick (59), of Crossgar Road East, Crossgar, had been due to go on trial next week on a total of eight charges.

Along with two counts of falsifying clinical trials, he faced a further four charges of fraud by false representation along with two counts of perverting the course of justice.

A jury was sworn in earlier today at Belfast Crown Court in front of Judge Piers Grant who told them the trial would start next Monday, April 25, and it was expected to last up to three weeks.

But in a dramatic twist this afternoon, counsel for McGoldrick, Frank O’Donoghue QC, told Judge Grant: “I have an application to have Dr McGoldrick re-arraigned on counts one and two on the amended bill indictment.’’

Standing in the dock, McGoldrick pleaded guilty to two charges that on dates between November 27, 2007 and June 30, 2008 he “conducted a clinical trial relating to the efficacy and safety of 2mg per day of M100907 on Sleep Maintenance Insomnia’’ in breach of the Medicines for Human Use (Clinical Trials) Regulations 2004.

The offences took place at his Pound Lane GP practice in Downpatrick.

David McDowell QC, prosecuting, said the pleas were acceptable to the Crown and asked that counts three to eight, relating to fraud by false representation and perverting the course of justice, be “left on the books and not to be proceeded with without the leave of this court or the Court of Appeal’’.

He added: “The defendant has pleaded guilty to counts one and two on the following basis:

“One, the defendant accepts that he conducted the clinical trial in deliberate breach of the trial protocol. The patients enrolled onto the clinical trial were probably not eligible to participate in it.

“Their probably ineligibility arose in one of the following four ways: they suffered from secondary insomnia; they were prescribed medication which would have excluded them from the study; the body mass index of one of the patients was too high and the body mass of another patient may have been too high; false information as to their sleeping patterns was knowingly submitted by the defendant via the interactive voice response system (IVRS).

“Two, the defendant accepts that in doing so he deliberately breached the conditions and principles of Good Clinical Practice which apply to all clinical trials.

“Three, the defendant maintains that he did so because he believed the medication would be beneficial to each of his patients. But that is not accepted by the prosecution.

“Four, the defendant agrees to repay all monies received in respect of the clinical trial in so far as they have not been repaid to date,’’ added Mr McDowell QC.

Defence QC Frank O’Donoghue told the court that “in so far as the monies are concerned, Dr McGoldrick has given an undertaking to repay all the monies’’.

He added that one of the companies he was conducting the trials for had now been liquidated and said if there was any money still owed to the firm McGoldrick would “make a cheque payable too a charity of the choice of the court’’.

Judge Grant adjourned sentencing until May 26 and ordered a pre-sentence report to be prepared.

Releasing him on continuing bail, the judge told McGoldrick: “I should make it absolutely clear to you that by releasing you should not be taken as any of indication of what sentence will be passed other than a custodial sentence.’’