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SECRETS
Research Fraud

 

This article appeared in the Campaign's Secrets newspaper in August 1993.

 

Many clinical trials are never published - which means that the published literature may give a very inadequate picture of what is known about a drug.

According to a recent article: "This phenomenon is particularly alarming because unpublished trials may have systematically different results from those that are published. This publication bias obviously increases the chances that reviews based only on published reports will themselves be biased and will in turn promote inappropriate health care". (1) 

Unpublished studies may even conceal fraud. Researchers using the US Freedom of Information Act obtained nearly 2000 US Food & Drug Administration audits of clinical trials. They learnt that the FDA had discovered "serious deficiencies" in 11% of cases, ranging from poorly designed studies to flagrantly falsified results. (2)  No similar study could be done in Britain, because of the secrecy clause in the Medicines Act.

The problem certainly exists here. The medical director of the Association of the British Pharmaceutical Industry, Dr Frank Wells, recently wrote: "For some time there has been an impression among British pharmaceutical physicians, clinical research associates, and quality assurance professionals that a small but significant amount of data supplied by British clinical investigators is fraudulent". (3) 

Footnotes

  1. I. Chalmers et al, British Medical Journal, 3.10.92. 786-8

  2. J. of the American Medical Assn, 5.5.89, 2505

  3. 'Fraud & Misconduct in Medical Research', BMJ Publishing Group, 1993.

 

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