Downpatrick GP sent to prison to await fate

Downpatrick GP sent to prison to await fate

22 June 2016

A DOWNPATRICK GP has spent almost a week in prison awaiting sentence for the first prosecution of its kind in the UK.

Dr Hugh McGoldrick, of Crossgar Road East, will be sentenced on Friday morning for falsifying a clinical trial involving 10 of his patients.

The 59 year-old doctor, who formally retired from practice earlier this month after working in Downpatrick for over 30 years, was remanded in custody on Friday for improperly conducting the trial of anti-insomnia medication in 2007 and 2008.

He had pleaded guilty in April to breaching trial protocol when carrying out a study on patients with sleeping disorders between November 27, 2007, and June 30, 2008.

Downpatrick Crown Court has heard details of how he recruited 10, mostly elderly, patients to the study, which involved over 1,800 people worldwide.

The alarm was first raised during a routine inspection visit to his Pound Lane practice in December 2007 when some irregularities were flagged. 

Doubts arose when inspectors noted that all of McGoldrick’s patients qualified for the trial following a one week pre-trial screening process.

Prosecutor David McDowell QC described it as “remarkable” that 100 per cent of McGoldrick’s trial group had qualified for the study following the week-long screening process, exhibiting “almost perfect sleep maintenance insomnia.”

He explained that McGoldrick’s patients needed to submit a daily sleep diary through a dedicated phone line to determine if they were suitable candidates during the first stage of the clinical trial. The court heard that just 53 per cent of candidates typically qualify and that a £500 payment was made for each patient who engaged in this screening process with an additional £1600 due for each one who completed the trial.

McGoldrick later admitted fabricating records for six of his patients who he claimed were reluctant to use the telephone system themselves.

When directly asked by Judge Piers Grant on Friday if the defendant had made up the responses he submitted to the phone line, defence barrister Frank O’Donoghue QC said; “That is right, that is what he had pleaded to and has accepted.”

The court heard that if the patients had gone through the correct screening process they would probably have been excluded from the study for a number of reasons including the fact that several participants were overweight, had pre-existing medical conditions that would disqualify them from the study or were taking medication that would interfere with their natural sleep pattern and would therefore make them unsuitable.

Investigators noticed inconsistent height and weight records of patients and evidence that some were receiving repeat preions for hypnotic medication, all of which would have made them ineligible.

The court heard, for example, that Patient Two was clinically obese and suffering from a respiratory disorder that affected her sleep.

Despite hospital records indicating she weighed between 90 and 94 kilograms at the time of the study, McGoldrick reported her to weigh 79 kilograms for the trial.

The court heard that he claimed to have weighed her in her home although she said that had never happened.

Patient Five was recorded as being five inches taller than she was, bringing her into the approved weight limits, four of the patients were being prescribed hypnotic drugs around the time of the trial and seven of the patients had pre-existing conditions causing pain or awakening.

“All 10 patients were probably ineligible,” the prosecutor said.

Mr McDowell said the consequences of McGoldrick’s actions were to the detriment of the study.

He said the patients, the records of two of which were found in the doctor’s garage during police search of his home in May 2009, were being put on a trial of medication that would not have any benefit to them because of the nature of their insomnia.

“It constituted a risk to them without a potential benefit,” he said.

“It may also not have been safe for them if they were also taking the other medicine.”

Pleading for leniency, defence barrister Frank O’Donoghue QC said the defendant, who had a previously clear record, had behaved “out of character” during the clinical trial, which was one of 24 such trials he had undertaken between 2004 and 2008.

If the defendant had made early admissions about the irregularities of his trial, Mr O’Donoghue said McGoldrick may have avoided criminal proceedings “and the total erosion of reputation that has gone with this.”

“His problem has been compounded by the fact he did not ‘fess up to his wrongdoing at an earlier stage,” he said.

“Where Dr McGoldrick went terribly wrong, whether it was an arrogance on his part, or a failure to accept his own wrongdoing, he continued to make the case that patients had been responsible for their own phone-ins.

“This is a product of being over-worked and over busy … It beggars belief as to why he was behaving so out of character.”

Mr O’Donoghue emphasised that the defendant did not undertake the clinical trial, which the court heard would have been worth over £20,000 upon completion, for financial gain and said outstanding money of around £9,200 had now been repaid. 

“Although there are sums of money that may appear significant, the sums of money are not the motivating factor for doing this work. There has been a desire on the part of Dr McGoldrick to do his bit, to assist the research aspect of the medical profession,” he said.

“He has always done it, not only out of a sense of interest but because he believes it does assist his patients.”

Mr O’Donoghue said the legal proceedings had been difficult for all concerned, but had been handled with dignity by all, including the defendant.

“He has lost his career, he has lost his reputation, he has had to deal with the publicity and the speculation of the community of the extent of his wrongdoing,” he said. “He is now at the lowest point of his life.”