Elderly patients used as guinea pigs

'Everything possible must be done to ensure the safety of patients in drugs trials'

Elderly patients were used as "guinea pigs" to test a range of new drugs without their knowledge, a disciplinary hearing was told yesterday.

They were used in various drugs trials conducted by Dr Geoffrey Fairhurst, in some cases after consent forms had been forged.

The General Medical Council's professional conduct committee was told that Dr Fairhurst also allegedly instructed a practice nurse to produce false ECG reports for patients participating in clinical drugs trials.

Dr Fairhurst, a JP and government adviser, had told the nurse that to inform patients of trials was "the kiss of death to recruit them," Rosalind Foster QC, on behalf of the GMC, said.

Dr Fairhurst, of Warrington, Lancashire, who qualified in 1962, denies serious professional misconduct.

Ms Foster told the hearing that Dr Fairhurst had abused a trusted position while conducting potentially dangerous tests on drugs for the treatment of people suffering from heart conditions and hypertension.

"The facts we will submit show that Dr Fairhurst's conduct of these clinical trials was highly irregular and dishonest," she said.

She went on to say that the charge against the doctor related to three separate drugs trials involving a number of elderly patients between 1988 and 1995.

The alleged misconduct was exposed by Dr David Edwards, the partner in his practice in St Helen's, Merseyside.

Ms Foster told the GMC committee: "You will appreciate the importance of clinical research must be conducted with scrupulous honesty. The rational behind this is that everything possible must be done to ensure the safety of patients in [drugs] trials.

"A patient's consent is fundamental and full documentation and records is necessary if a problem in their care should arise."

She said that pharmaceutical companies also expected doctors carrying out trials to do so honestly. "Doctors are remunerated on this basis for good and honest work," she added.

Ms Foster said a danger of including people unknowingly into the tests could be to lead to inaccurate information which would be the basis of new drugs released to the public. As a result there was a risk of "grave danger to the public."

Dr Fairhurst, who had been involved in clinical trials for several years, had resorted to the alleged dishonesty as "a way of topping up the numbers of patients" involved.

The hearing was told that many patients had given their consent to be a party to the trials. But Ms Foster said that in the case of several elderly people a consent form had been forged, or the doctor had written a statement falsely claiming that a patient had consented to participate.

It was alleged that on 23 January 1995, the doctor instructed Irene Hill, the practice nurse, to produce false ECG reports in respect of several patients involved in the tests.

When she remonstrated with him about some of his orders he ceased to give her any further work. Ms Foster said Mrs Hill would tell the committee of Dr Fairhurst's reluctance to inform patients of trials.

He also is alleged to have advised the giving of medication in trials on prescription "to avoid confusing the elderly ... they may think they were being used as guinea pigs"

The charges laid against Dr Fairhurst relate to a study on 10 February 1988 conducted by Glaxo Pharmaceuticals UK Ltd, on the efficacy and safety of the drug lacidipine with atenolol in patients suffering from moderate hypertension.

A second study by Merck Sharp & Dohme in April 1981, was launched to investigate a drug enalapril with hydrochlorothiazide and enalapril, also for the treatment of elderly patients suffering from essential hypertension.

The third trial on 25 February 1993, by Leo Laborotories Ltd, investigated the effects of diuretics, bumetanide plus captopril, for patients with congestive cardiac failure.

Dr Fairhurst accepts that he admitted patients to the drugs trials, but he insists that they gave their consent. He also denies forging any consent forms.

The hearing continues.