In March 1993 a company commenced a randomised double blind placebo controlled multicentre clinical trial in both hospital and general practice on the efficacy of a new treatment for severe depression. Soon after, another company commenced the UK component of a randomised double blind multinational clinical trial on the effects of a new medicine on high risk patients with hypertension.11
One of the investigators chosen for both studies, though quite independently, was Dr James Bochsler, a single handed general practitioner in Upper Norwood, South London. He had not previously conducted any research for the first company, but had expressed an interest in taking part to one of the company field force representatives, to whom he had also stated that he had done a number of studies previously for other companies. He had, indeed, previously conducted research for the second company and had been selected to take part in the hypertension study according to that company's strict criteria.
With regard to the first study, on a treatment for depression, setting-up the study centre for Dr Bochsler took some time, as he had to be issued with the guidance to investigators booklet published by the ABPI, to attend a preliminary investigators' meeting and to satisfy the company that he was prepared to conduct the clinical trial in accordance with these guidelines. This was done, and he duly signed an agreement, which included a commitment to conduct the study strictly in accordance with the principles contained within the Declaration of Helsinki. At the investigators' meeting he had expressed unhappiness at the prospect of direct source document (medical record) verification (SDV) by the company monitor and he was reluctant to obtain Local Research Ethics Committee approval, but both these concerns were overcome.
Dr Bochsler duly started the trial and monitoring visits began. To begin with, it appeared from these monitoring visits that recruitment was very good, and that data recording, drug accountability, and source document verification were satisfactory. However, suspicions soon began to be raised. First, a large number of patient assessments, which were clearly missing on the first day of a monitoring visit, had all mysteriously appeared by the following day. Next, medication bottles, which should have been issued to all of these patients, if they had attended for assessments on the due dates, were still present in Dr Bochsler's surgery. When challenged, he alleged that the patients, whose medication was still in the surgery, had been withdrawn from the study for administrative reasons. The opportunity was taken to obtain photocopies of all the signed consent forms, as Dr Bochsler appeared to have seen a number of patients when, according to the practice appointments book and diary, he was on holiday.
The situation was investigated further and a number of patients were interviewed. Several patients confirmed that they had not given consent to take part in a study, and at least one patient did not appear to exist.
With regard to the second study, on a treatment for hypertension, routine monitoring took place and, again, it appeared at first that recruitment was good, and that data recording, drug accountability, and source document verification were satisfactory. Dr Bochsler was selected routinely for audit, as part of standard company practice. Suspicions then became roused. In particular, these included electrocardiogram tracings (ECGs), which had been duplicated and re-assigned to different patients; and returned medication, which appeared in pristine condition apart from crushing of the outer packaging of each box in a similar fashion. Similarities in handwriting for the signatures of certain patients was noted on the consent forms, which were duly photocopied. Further investigations were therefore conducted, and a number of patients were interviewed, many of them confirming that the signatures on the consent forms purporting to be theirs were clearly forgeries.
Both cases were submitted to the General Medical Council as examples of serious professional misconduct, and at a hearing of the professional conduct committee Dr Bochsler's name was erased from the Medical Register. Standard GMC procedure is to allow 28 days to elapse during which time the doctor may consider an appeal before erasure takes place but, unusually, this erasure was with immediate effect, as the professional conduct committee felt that the offences were so serious that the chance of their being repeated had to be stopped at once.
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