The Vioxx (rofecoxib) saga “offers important lessons about how best to promote constructive collaboration between academic medicine and industry,” according to Harlan Krumholz, professor of medicine and epidemiology and public health at Yale University School of Medicine, and collaborators. “Academic medicine, industry, medical journals, and government agencies need to come together to define a set of principles by which we can restore faith in collaborations on new treatments that can improve patient care,” the authors write in the British Medical Journal (2007;334:120-3).
The paper offers several suggestions to bolster the collaboration between academics, clinicians, industry and journals. Firstly, for example, the authors suggest that the data from clinical studies should be stored on an academic site, analysed by investigators who are not employed by the sponsor, and made accessible to the public. They also call for independent audits to ensure that companies follow a standardised, predefined protocol.
Secondly, boards monitoring data and safety should be truly independent. Industry should neither select members of these boards nor compensate participants, Krumholz and colleagues argue.
More rigour needed by medical journals
Thirdly, medical journals need to be even more rigorous when considering pharma-sponsored studies than they are at the moment. “Studies with immense financial implications require a higher level of scrutiny than others,” they comment. They called for journals to pay “particular attention to the possibility of bias." Furthermore, only authors without financial conflicts of interest should write the accompanying editorials. The paper also needs to include full disclosure of authorship, including ghost-writing.
Fourthly, when journals discover that information has been withheld or that results are incorrect, they need to rapidly inform readers of the mistake. Web searches should identify the original manuscript and the correction. Authors should sign an agreement to notify journals if they become aware of withheld information or a mistake. Failure to do so would result in the journal blacklisting the author.
Krumholz and colleagues remark that collaborations between academics, clinicians, industry and journals help advance knowledge and improve patient care. This partnership depends, however, on trust. “Recent events have made it necessary to institute proper systems that protect the interests of patients,” they conclude. “A renewed commitment by all those involved and the institution of these systems are the only way to extract something positive from this unfortunate affair.” By Mark Greener