Intended for healthcare professionals


GP found guilty of forging trial consent forms

BMJ 1998; 317 doi: (Published 28 November 1998) Cite this as: BMJ 1998;317:1475
  1. Owen Dyer
  1. London

    A UK general practitioner who forged patient consent forms for clinical research was paid over £23000 ($36800) before the fraud was uncovered, according to evidence presented last week to the General Medical Council.

    Dr James Bochsler, 58, sole practitioner at the Pasteur Primary Care Centre in south London, was struck off after being found guilty of serious professional misconduct. He had fraudulently entered patients in to two trials, one of the antidepressant fluvoxamine maleate, the other of nifedipine, a treatment for angina and hypertension.

    Duphar Scientific Research, now called Solvay Healthcare, audited Dr Bochsler because he had entered 46 patients, compared to a typical figure of 10, into a trial of fluvoxamine.

    The first two visits by the auditor revealed nothing out of the ordinary. On the third visit, however, Dr Bochsler appeared to have forgotten about the appointment, and the auditor found that no new entries had been made since her last visit. Duphar engaged a medicolegal investigative firm and warned Dr Bochsler not to enroll any more patients.

    Discrepancies were also found in Dr Bochsler's data during an internal audit by Bayer, which had employed him in a trial of nifedipine. Bayer had the consent forms examined and the electrocardiograms that had been taken to exclude patients from the study. In five cases, identical printouts had been sent in for two different patients.

    Handwriting experts found that of 36 consent forms examined from the two trials, at least 25 had not been signed by the patient concerned. Eighteen patients called as witnesses confirmed that they had neither signed the forms nor received the drugs.

    The chairman of the professional conduct committee, Dr John Ball said: “Scientific dishonesty producing bogus results undermines the integrity of drug trials.”

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