Possible suppression of data

This is a summary of a problematical research interaction between a pharmaceutical company and academic collaborators at a University involving a widely used drug. A pharmaceutical company appears to have exerted undue influence in an attempt to control the scientific literature.

1. The research involved an important retrospective secondary endpoint in the three key randomised trials used to prove the efficacy of this drug for regulatory approval.
2. It is critical to understanding of the mechanism of this class of drugs. The outcome of the research also has practical clinical relevance in terms of choice of drug therapy and therapeutic monitoring. It is pertinent to interpretation of a recent head-to-head trial of this drug versus its main competitor. The information is also relevant to a wider debate about the evidence required for regulatory agencies to licence related drugs.
3. For the company there was an important issue at stake in terms of the outcome of this research.
4. This core problem involved refusal of the pharmaceutical manufacturer to provide crucial raw data (principally randomisation and event codes and information about confounders) to clinical academic collaborators. Thesedata were required by the academics to verify scientific reports, statistical analyses, meeting abstracts, and draft publications "ghost written" by the company in their names.
5. Initial refusal to supply data was compounded by continued refusal even after considerable information emerged to suggest that data analysis and data presentation had been incorrect and misleading. It appeared that "fair" analysis of the data might not have yielded findings desired by the sponsor. This interfered with the ability of the academics to discharge their duties as responsible scientists and medical doctors. It prevented correction of the published literature. It also violated the actual and implied terms of contract between the sponsor and the academic institution.
6. Later evidence emerged to convince one academic (the intended first author and first author on abstract presentations) that information presented in his name had been misleading. The company and his collaborator then attempted to alter the study hypothesis in retrospect and threatened to eliminate him as author if he refused to sign consent for publication even though he had not seen the data. They maintained that PhRMA guidelines justified their actions and that access of authors to data is not required.
7. These events were brought into focus by resulting poor collegial relationships, conflicts of interest, and other alleged research misconduct. Collaborators disagreed over the right balance between honesty and the need to secure funding from the sponsor.

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