Possible suppression of data
Case text (Anonymised)
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.
- 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.
- 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.
- For the company there was an important issue at stake in terms of the outcome of this research.
- 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.
- 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.
- 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.
- 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.
What should the editor do next?
The journal could publish the entire story. The paper sounds unpublishable and the study is not hosted by an institution, so there is no apparent investigative body. This was similar to another case where an author objected to the other authors and was hounded out of her position.
It was suggested that this could be a case for the Panel for Research Integrity. The ABPI was also suggested, but it was pointed out that this is voluntary and a ‘toothless tiger’. The HMRA could be another possibility. The committee discussed what the author could do; there were several suggestions, for example - get legal advice orpass the material to an investigative journalist. Also if published the author could write to the GMC concerning any named authors who are on the medical register if he believes the material is fraudulent.
Among the recommendations made by COPE was a suggestion that the author should contact the MHRA and may wish to discuss his concerns with an investigative reporter. It appears that the author took up this suggestion, as a story about the matter appeared first in the Times Higher Educational Supplement and then on the front page of the Observer (a national UK Sunday newspaper) on December 4th. The matter is also being investigated by the Medicines and Healthcare products Regulatory Agency.