Crisis

In the winter of 1993 events took a turn that focused my attention on the problem and made me explore my own feelings further when a new partner and a medical researcher joined the practice.

Dr Min Shah had just finished vocational training and this was her first partnership. I found her extremely likeable and honest and soon developed a good working relationship with her. Jean Young had worked for ICI, and latterly Zeneca, for many years in its research department. She was a highly qualified nurse and had met Dr Fairhurst many years ago when he was working in a Liverpool hospital. She had decided to set up her own business coordinating pharmaceutical trials. Geoff had suggested that she rented a room in our surgery and work from the practice, recruiting patients from our list. She was a forthright and honest woman and I had no problems in agreeing to this proposal. Before long Jean came to me with her own concerns regarding Dr Fairhurst's conduct in his trials. She was concerned regarding lack of informed consent and poor drug accountability. She had discovered this while assisting Dr Fairhurst with his work while he was on holiday.

Dr Shah soon had her own suspicions that Geoff's research work was not being conducted ethically. She had quickly attracted a number of patients who were upset by the frequency of investigations requested by Dr Fairhurst. It was apparent to her that these were patients with hypertension who appeared to be taking or had taken study medication.

To her great consternation it was also clear that many were unaware that they were enrolled in pharmaceutical trials. Crucially Dr Shah discovered a signed consent form in a patient's notes relating to a study. When this consent was shown to the patient, she declared the signature was not hers. This was to become part of the evidence presented to the General Medical Council.

At this time I became further involved when an elderly patient died of digoxin toxicity. It was clear that this was due to her having two medicine bottles of digoxin at home and taking them simultaneously. She was also enrolled in a study, a fact I confirmed with the sponsoring pharmaceutical company. I was horrified to find that Dr Fairhurst had altered, in his handwriting, hospital consultants' letters and entries in her medical records made by myself. The effect of these alterations was to change the medical record to make the patient eligible for inclusion into his study. I knew that the alterations had no basis in fact as I had been seeing her regularly until a few months previously. The study involved two medicines that were available on prescription. To complete the deception and to avoid having to get patient consent or arouse suspicion, the study medicine packs were being discarded and NHS prescriptions issued for their equivalents.

My conclusion was that during the substitution of prescription for study medicine the extra digoxin had been supplied in error. I discussed these developments with Dr Shah and Mrs Young and immediately contacted my medical defence organisation and the medical director of the pharmaceutical company involved.

Advice from the defence organisation was vague and unhelpful, apart from the simple fact that we had a duty to report our concerns to a responsible body, probably the General Medical Council. The medical director of the drug company was quite clear that he could not believe my story and that Dr Fairhurst was well respected in this area of research and personally known to him. He then contacted Dr Fairhurst and reported the details of our conversation to him. We needed help and we needed it fast so I contacted the General Medical Council for guidance. They sent me information, intended for patients, outlining the complaints procedures. I now knew that a complaint brought some years previously to the local medical committee about Dr Fairhurst's conduct of pharmaceutical studies had not been taken further and, to complicate matters, Dr Fairhurst sat on the local ethical committee.We feared the old boy network and did not wish to present the matter locally; as a consequence we were floundering and did not know where to turn.

I approached Dr Fairhurst with my concerns regarding his research work. As expected, he denied that there were any problems and insisted that all his work was being done ethically. He concluded the meeting with the expected suggestion that he would dissolve our partnership and take the majority of the patients with him. A friend in the pharmaceutical industry suggested that we contact the Association of the British Pharmaceutical Industry. This organisation, and in particular its then medical director, Dr Frank Wells, was to be a great source of help and support.

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