Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?
Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?
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DOI：
10.1111/j.1365-2125.2008.03272.x
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发表时间：
2008-12-01
影响因子：
3.4
通讯作者：
Loke, Yoon K.
中科院分区：
文献类型：
--
作者：
Golder, Su;Loke, Yoon K.
关于这一主题的已知情况业界资助的研究倾向于强调赞助商产品的有利作用，但我们不知道是否对不良影响的报道被淡化了。制药公司必须整理和准确报告不良反应数据，以满足监管要求。在研究行业资助和有益效果报告之间关系的研究中发现的偏见在考虑不良影响数据时可能不那么突出。在报告原始不良反应数据方面，工业资助的研究与非工业资助的研究似乎没有区别，但解释和结论可能倾向于赞助商的产品。行业资助研究的读者应该严格检查原始安全数据，而不是被作者的解释所左右。调查在制药行业资助的研究中，赞助商产品的不良反应数据是否比在非制药行业资助的研究中更有利。我们对评估行业资助与报告的不良反应风险之间关系的方法学评估进行了系统回顾。在10个数据库中进行了检索，并辅以其他信息来源，如手工检索、引文检索、检查会议记录和与专家讨论。两名审稿人独立筛选记录，并对可能相关的论文进行数据提取。我们纳入了根据资金来源比较结果和不良反应数据解释的研究（例如，制药行业研究的不良反应数据与非营利组织的数据，或一个制造商与另一个制造商的数据）。如果研究人员没有明确说明资助来源的类别，并且如果我们不确定评估中是否存在行业资助的研究，则排除方法学评估。搜索策略产生了4069个结果，其中6个方法评估符合我们的纳入标准。一项涵盖广泛主题的370项试验的调查发现，与非行业资助的试验相比，由行业资助的试验有更完整的不良反应报告，而另一项针对504项吸入皮质类固醇研究的调查显示，在调整混杂因素后，没有明显差异。相比之下，我们从事后亚组分析中发现证据，涉及两种产品，与非制造商资助的研究相比，制造商资助的研究中危害的可能性更低。从四项方法学评估中也有证据表明，有行业资助的作者比没有制药公司资助的作者更有可能解释和得出药物是安全的结论，即使在研究中确实发现赞助产品的不良反应在统计上显著增加。我们的回顾表明，行业资助可能不是报告原始不良影响数据时存在偏见的主要威胁。然而，我们担心在行业资助的作者和研究的解释和结论中存在潜在的偏见。
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECTcenter dot 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.center dot Pharmaceutical companies are required to collate and accurately report adverse effects data in order to fulfil regulatory requirements.WHAT THIS STUDY ADDScenter dot 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.center dot 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.center dot Readers of industry-funded studies should critically examine the raw safety data themselves rather than be swayed by the authors' interpretation.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.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.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.Our review indicates that industry funding may not be a major threat to bias in the reporting of the raw adverse effects data. However, we are concerned about potential bias in the interpretation and conclusions of industry-funded authors and studies.