Downpatrick GP admits to falsifying of clinical trials in late plea

Downpatrick GP admits to falsifying of clinical trials in late plea

27 April 2016

A DOWNPATRICK GP will be sentenced next month for falsifying clinical trials on his patients.

Dr Hugh McGoldrick has pleaded guilty to breaching trial protocols when carrying out a study on patients with sleeping disorders between November 27, 2007, and June 30, 2008.

The 59 year-old GP, of Crossgar Road East, Crossgar, unexpectedly admitted two charges against him when he appeared at Downpatrick Crown Court sitting in Belfast on Friday afternoon.

Six further charges, relating to fraud and perverting the course of justice, were not proceeded with following McGoldrick’s last minute plea.

The guilty pleas came after a jury was sworn in Belfast on Friday morning and told to expect the three week trial to begin on Monday.

Defence counsel, Frank O’Donoghue QC, applied to have the GP re-arraigned on counts one and two on the amended bill indictment.

Standing in the dock, McGoldrick, who practised at Pound Lane Clinic before moving to the Downe Hospital, pleaded guilty to breaching regulations in two clinical trials assessing the safety and efficacy of drugs for insomnia.

Prosecuting counsel, David McDowell QC, said the pleas were acceptable to the Crown and asked that the remaining charges, 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 said 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,” he said. 

“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.

“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.

Mr 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 to a charity of the choice of the court.”

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

Releasing him on continuing bail, the judge told McGoldrick: “By granting you bail you should not take that as an indication you will receive something other than a custodial sentence. It will be determined by what I hear at the hearing on May 26.”

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.”