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Doctor admits falsifying drug trials on patients with sleeping disorders

A County Down doctor has pleaded guilty to falsifying clinical trials on patients with sleeping disorders.

Dr Hugh McGoldrick of Crossgar Road East, Crossgar, was 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.

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

A jury was sworn in at Belfast Crown Court but McGoldrick's lawyer requested that his client be "re-arraigned on counts one and two".

McGoldrick, 59, pleaded guilty to two charges that on dates between 27 November 2007 and 30 June 2008 he conducted a clinical trial in breach of the Medicines for Human Use (Clinical Trials) Regulations 2004.

'Left on the books'

A prosecution lawyer said that 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 probable 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.

Freed on bail

"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."

A defence barrister told the court that McGoldrick had given an undertaking to repay all the money.

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 to a charity of the choice of the court''.

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

In a statement afterwards, McGoldrick's solicitor said: "Dr McGoldrick entered pleas of guilty solely on the basis that the tests were for the benefit of patients and that there was no dishonesty involved for any pecuniary gain."

Source: http://www.bbc.com/

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