The case of the challenged company

In 1996 a pharmaceutical physician moved from the French subsidiary of an international company to a different company in England. On his arrival in the UK he shared with the managing director of the company he had just joined his concerns that the data accompanying a marketing authorisation submission to a national licensing authority were incomplete, leaving out some of the adverse reactions that had been reported during certain clinical trials, the positive (efficacy) results of which had been included in their entirety. Clearly the doctor felt strongly that he should whistleblow in this case, with which his new managing director concurred. However, the managing director recommended that the facts should be fully ascertained first and the case was therefore next referred to MedicoLegal Investigations.

These began by interviewing the research director of the parent company of the French subsidiary so as to secure his complete cooperation and his confidence in what MLI would be investigating. The medical director and chief executive of the subsidiary company were then interviewed and the safety information within the dossier submitted to the licensing authority was reviewed. It became apparent that the dossier clearly included the complete safety data arising from all the clinical trials referenced in the dossier, as well as the efficacy data. The grounds for the whistleblower's concerns were thus not confirmed. Further enquiries confirmed that no other studies had been conducted on the investigational substance in question, and there was therefore no suggestion that the overall picture regarding the product might have been distorted by any selection of studies to be included in the submission. However, it also became clear that, for reasons which never became entirely clear, though likely to be related to why the doctor chose to change companies at this stage in his career, the whistleblower had not had access to the final dossier submitted to the licensing authority.

It was accepted that the whistleblower had acted in good faith, even though his concerns were unfounded. The company concerned accepted that, for itself, it had learned from this episode that it needed to ensure that those who had responsibility for compiling the safety and efficacy data for a marketing authorisation submission were fully informed regarding the contents of the final submission. The pharmaceutical physician involved has since moved on from his post in the UK.

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