Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry‐funded studies?

Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Industry‐funded studies tend to emphasize favourable beneficial effects of the sponsor's product, but we do not know if reports of adverse effects are downplayed. • Pharmaceutical companies are required to collate and accurately report adverse effects data in order to fulfil regulatory requirements. WHAT THIS STUDY ADDS • The bias found in the studies looking at the association between industry funding and reporting of beneficial effects may not be as prominent when considering adverse effects data. • Industry‐funded studies do not appear to differ from non‐industry‐funded studies in reporting the raw adverse effects data, but the interpretation and conclusions may be slanted to favour the sponsor's product. • Readers of industry‐funded studies should critically examine the raw safety data themselves rather than be swayed by the authors' interpretation. AIM To investigate whether adverse effects data for the sponsor's product are presented more favourably in pharmaceutical industry‐funded studies than in non‐industry‐funded studies. METHODS We conducted a systematic review of methodological evaluations that had assessed the relationship between industry funding and the reported risk of adverse effects. Searches were undertaken in 10 databases and supplemented with other sources of information such as handsearching, citation searching, checking conference proceedings and discussion with experts. Two reviewers independently screened the records and carried out data extraction for potentially relevant papers. We included studies that compared the results and interpretation of the adverse effects data according to funding source (e.g. adverse effects data in pharmaceutical industry research vs. data from nonprofit organizations, or from one manufacturer vs. another). Methodological evaluations were excluded if categories of funding source were not explicitly specified by the researchers, and if we were uncertain that industry‐funded studies were present in the evaluation. RESULTS The search strategy yielded 4069 hits, of which six methodological evaluations met our inclusion criteria. One survey of 370 trials covering a wide range of topics found that trials with industry sponsors had more complete reporting of adverse effects compared with non‐industry‐funded trials, whereas another survey of 504 inhaled corticosteroid studies showed no apparent difference after confounding factors were adjusted for. In contrast, we found evidence from post hoc subgroup analyses involving two products where the likelihood of harm was of a lower magnitude in manufacturer‐funded studies compared with nonmanufacturer‐funded studies. There is also evidence from four methodological evaluations that authors with industry funding were more likely than authors without pharmaceutical funding to interpret and conclude that a drug was safe, even among studies that did find a statistically significant increase in adverse effects for the sponsored product. CONCLUSIONS Our review indicates that indus...

The Drug Facts Box: Improving the communication of prescription drug information

“…Published reports of clinical trials in medical journals are another important source of drug information for physicians. Unfortunately, a growing body of literature has documented disturbing problems with the quality of published research reports, particularly when they are industry sponsored, including selective publication of trials with favorable results (25-29), selective reporting of favorable outcomes (26,30,31), and "spinning" results and conclusions to overstate the benefit of an intervention (32)(33)(34) or to minimize the side effects (35).…”

Physician and Stakeholder Perceptions of Conflict of Interest Policies in Oncology

“…COIs have the potential to affect how information is presented in scientific journals and medical education forums. 7,8 As a result, many medical professional organizations, including the American Society of Clinical Oncology (ASCO), have COI policies in place to address the industry relationships held by…”

Most systematic reviews of adverse effects did not include unpublished data

“…Nevertheless, previous research of systematic reviews of adverse effects from 1994 to 2011 has indicated that, few attempts are made to search for unpublished data or industry funded data (10,15). This may be due to an expected low return or the difficulties of searching for unpublished data or in obtaining and incorporating unpublished data into systematic reviews (16) or a concern that unpublished data is not peer reviewed.…”