Letters

Fraud

BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7172.1590 (Published 05 December 1998) Cite this as: BMJ 1998;317:1590

This article has a correction. Please see:

Fair and efficient system of investigating alleged misconduct can be devised

  1. Lars Breimer, Clinical research physician
  1. 24 Manor Park, Richmond, Surrey TW9 1XZ
  2. Association for Clinical Research in the Pharmaceutical Industry, Good Clinical Practice Forum,PO Box 1208, Maidenhead, Berkshire SL6 3GD
  3. St Helens and Knowsley Hospitals NHS Trust, Prescot, Merseyside L35 5DR
  4. Tees Stroke Register, University of Newcastle, Newcastle upon Tyne NE2 4HH
  5. Unity Laboratory of Applied Neurobiology, Guildford, Surrey GU1 2BX
  6. Division of Obstetrics and Gynaecology, Guy's, King's College, and St Thomas's School of Medicine, London SE1 7EH

    EDITOR—Only one of the five papers on dealing with research misconduct in the United Kingdom (that by Riis) mentions the pharmaceutical industry and the national medicines regulatory agencies—and only as an aside.1Licences for drugs are granted on studies conducted by pharmaceutical companies and assessed by the regulators, so fraud endangers safety.

    In the United Kingdom the pharmaceutical industry has been responsible for uncovering misconduct and fraud. The initial evidence is usually obtained by the company's clinical research associates who monitor the centres. Fraud can include falsification of data (even phantom patients) and the ethics review process.

    A company loses on average about £650 000 ($1m) a day in delay in registering a new drug. In addition, conducting a trial to good clinical practice standards costs about £20 000 ($32 000) a patient. Thus if a 25-patient study has to be repeated and 100 days are lost a company can lose over £1m ($1.6m); in the case of a 400-patient study requiring two years from start to finish it can lose about £500m ($800m). In addition, the reputation of the company is at stake. In the United Kingdom companies hand over the evidence that they have gathered about fraud to the institution where the person works and lets it act. If officers of medical schools or district general hospitals were to find themselves facing a bill of £500m plus legal costs, they would soon devise a fair and efficient system of investigating alleged misconduct.

    References

    Pharmaceutical industry follows guidelines on conduct of research

    1. Laura Brown, Chairwoman
    1. 24 Manor Park, Richmond, Surrey TW9 1XZ
    2. Association for Clinical Research in the Pharmaceutical Industry, Good Clinical Practice Forum,PO Box 1208, Maidenhead, Berkshire SL6 3GD
    3. St Helens and Knowsley Hospitals NHS Trust, Prescot, Merseyside L35 5DR
    4. Tees Stroke Register, University of Newcastle, Newcastle upon Tyne NE2 4HH
    5. Unity Laboratory of Applied Neurobiology, Guildford, Surrey GU1 2BX
    6. Division of Obstetrics and Gynaecology, Guy's, King's College, and St Thomas's School of Medicine, London SE1 7EH

      EDITOR—We welcome the articles on research misconduct but would like to draw attention to two issues.1 Firstly, some of the articles imply that there are few, if any, guidelines in the United Kingdom for the conduct of research. In fact, detailed guidelines which include information on the protection of patients and the validity of …

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