Top Surgoen `Put Patients at Risk'; Professor in Ethics Row Is Reprimanded . . . While His Whistleblower Is Accused of Misconduct
Byline: KIM WILLSHER;MARTYN HALLE
A LEADING surgeon has been accused of deceiving more than 70 hospital patients and putting them at risk in an experimental drug trial.
Professor John Primrose was reprimanded by the General Medical Council after failing to comply with a strict ethical ruling, but avoided being struck off or disciplined.
Nearly half of the trial patients whose records were examined later developed serious infections after major surgery and required 'rescue' treatment.
The decision merely to admonish the surgeon, made by a GMC committee sitting in private, has surprised former colleagues who claim he ignored the drug test rules.
However an experienced colleague who felt morally and professionally obliged to report the incident was later accused of misconduct for whistle-blowing.
The case emerged after a recent report claimed that the lives of human guinea pigs were being endangered through serious breaches in ethical procedures.
And it has thrown light on a notoriously secretive medical world riven with intense competition for lucrative and prestigious contracts with drug companies.
When Scotsman John Primrose, a reputedly brilliant academic and general surgeon just turned 40, took up the post of Professor of Surgery Southampton University Medical School in October 1993, he was understandably anxious to make his mark. He applied to the ethics committee at Southampton General Hospital for permission to conduct a trial of a new antibiotic, Cipro-floxacin, on patients requiring abdominal surgery.
At any time, around 3,000 experiments on new medicines are being carried out in Britain. Each must be approved by a hospital or health authority ethics committee and conducted with the signed, informed consent of the patients involved.
The trials, paid for by pharmaceutical companies, are a vital source of funding for medical research. While individual doctors gain little financial benefit, such contracts can lead groundbreaking discoveries.
But Professor Primrose's application was turned down after a fellow academic and surgeon raised serious medical concerns with the committee about the trial. Senior consultant Stephen Karran - who had conducted earlier research on Ciprofloxacin - said studies had shown it might be ineffective if given with other pre-operation drugs as Prof Primrose proposed.
The professor was told he could go ahead with the trial only if he agreed to administer the antibiotic at a specific time before surgery stipulated by the committee. The following month, the professor wrote back: 'I am happy to ensure that the antibiotic is given in accordance with the committee's wishes.' The Ciprofloxacin trial began in February 1994, but unbeknown to the ethics committee or the 70 patients involved, the instruction was not followed.
Although the effect of this failure to comply with the committee's directive is unclear, it was later discovered that 28 out of 61 patients given Ciprofloxacin and whose records were available developed 'I'd understand if it was pressure of work'
serious infections needing treatment with powerful drugs after their operations - well over double the expected number.
Former policeman John Whale, then a member of the ethics committee, was astonished when he discovered the ethical rules had been contravened.
'If this had been inadvertent or pressure of work I could understand, but I had the feeling it was not,' he said.
'The amendment we stipulated was to be followed as a specific condition of the research going ahead. I
was very shocked to discover this condition was not being adhered to.' He said Prof Primrose was asked to explain his actions to the committee: 'Had there been any contrition about this it might have been a different matter,' he said. …