In mid-1992, the major international company, Pfizer, decided to conduct a double blind placebo-controlled parallel group clinical trial assessing the safety and efficacy of a new medicine in patients with heart failure and impaired renal function, inadequately controlled on the treatment that they had been taking, unaltered, for at least eight weeks.13
One of the investigators chosen by Pfizer to conduct this study was Dr John Anderton, a consultant general physician with a known interest in renal medicine, who was based at the Western General Hospital, Edinburgh. He had previously conducted a number of other studies for the company and was recognised as a distinguished doctor who had previously served as an office-holder of one of the medical royal colleges.The protocol and the usual agreements were signed by both parties; specifically, Dr Anderton agreed to conduct the study as described in the protocol, carried out in conformance with the Declaration of Helsinki, including the obtaining of informed consent from all participating subjects.
Recruitment and assessment of patients for this study appeared satisfactory to start with, but, during a routine visit at which the hospital notes were being checked against entries in the study report forms, the clinical trial monitor suddenly noticed that several patient signatures on the study consent forms were not consistent with patient signatures elsewhere in the hospital notes.The company arranged for two audits to be carried out at Dr Anderton's centre and a number of irregularities were discovered, which are set out below. As a result of these irregularities having been brought to light over this study, Pfizer decided to review the work previously conducted by Dr Anderton on its behalf, and found a number of additional acts of misconduct.
The case was referred to MedicoLegal Investigations and a number of witnesses were interviewed. It was clear that several of the recruited patients were not aware that they had been put into a clinical trial and that their consent had not been sought, let alone obtained. Dr Anderton's personal assistant had also been required, by Dr Anderton, to sign that she had witnessed patients' signatures, which did not, in fact, exist. These are the acts of misconduct committed by Dr Anderton in the course of the two Pfizer studies:
• All the echocardiogram and nuclear medicine data for patients were provided on forms that were no longer used in their respective departments. There was no evidence that the information on these forms had ever been generated by the departments concerned. Dr Anderton, when challenged, admitted that these data were bogus but attributed them to a research fellow working with him at the time, but the research fellow appears to have been invented as Dr Anderton had no records on him, no CV, no forwarding address, and no previous (or subsequent) correspondence.
• Records had been made of the involvement of some patients, and of the effects of their randomly allocated treatment, before they had actually been put on such treatment.
• There were discrepancies between the case report forms and the information given in letters to general practitioners of a number of patients. The letters revealed that the patients' treatment had been altered at least once during the eight weeks preceding the start of the clinical trial, which meant that they were not eligible for the study. However, they were still entered - but the case report forms for these patients stated that their treatment had not altered during the preceding eight weeks.
• Although the hospital outpatient register confirmed the appointments for the patients in the study for their first and fourth visits, the register showed no appointments for them on the reported dates of their second and third visits.
• Some of the ECG tracings and some of the patients' x rays had been cut to remove either the date on which they were taken, or the patient identification, or both.
• There was no evidence in certain cases that x rays were ever taken at all.
• A number of patients were purported to have been seen on three separate Scottish Bank Holidays when the hospital outpatient department was closed.
• Thirteen patient visits were purported to have taken place when Dr Anderton was on holiday, but there was no evidence of recorded cover during this period.
• Compared with the results reported from other centres taking part in the second study, which was reviewed by the company, Dr Anderton's results showed remarkable consistency in the intervals between patient visits, and in the timing of taking blood samples. On the other hand, he demonstrated a rise in blood drug metabolite levels when every other centre demonstrated a fall, he reported one-eighth of the adverse events per patient reported by the other centres - those adverse events, which he did report, being exactly as indicated on the data sheet for the products in question, whereas many of the other reported adverse events differed widely from those included in the data sheet.
The case was submitted to the General Medical Council and, at the hearing of the professional conduct committee, Dr Anderton pleaded guilty to a charge of serious professional misconduct. Despite receiving a number of character references from some of his distinguished colleagues, the committee directed that his name be erased from the Medical Register.
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