Fair and efficient system of investigating alleged misconduct can be devised

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.

Pharmaceutical industry follows guidelines on conduct of research

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 …