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行业指南、法律法规被忽视:医学期刊中药品广告的质量

Industry guidelines, laws and regulations ignored: quality of drug advertising in medical journals.

作者信息

Lankinen Kari S, Levola Tero, Marttinen Kati, Puumalainen Inka, Helin-Salmivaara Arja

机构信息

ROHTO Programme, Finnish Medical Society Duodecim, P.O. Box 713, FI-00101 Helsinki, Finland.

出版信息

Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):789-95. doi: 10.1002/pds.1017.

Abstract

PURPOSE

To document the quality of evidence base for marketing claims in prescription drug advertisements, to facilitate identification of potential targets for quality improvement.

METHODS

A sample of 1036 advertisements from four major Finnish medical journals published in 2002. Marketing claims were classified in four groups: unambiguous clinical outcome, vague clinical outcome, emotive or immeasurable outcome and non-clinical outcome. Medline references were traced and classified according to the level of evidence available. The statistical variables used in the advertisements were also documented.

RESULTS

The sample included 245 distinct advertisements with 883 marketing claims, 1-10 claims per advertisement. Three hundred thirty seven (38%) of the claims were referenced. Each claim could be supported by one reference or more, so the number of references analysed totalled 381, 1-9 references per advertisement. Nine percent of the claims implied unambiguous clinical outcomes, 68% included vague or emotive statements. Twenty one percent of the references were irrelevant to the claim. There was a fair amount of non-scientific and scientific support for the 73 unambiguous claims, but not a single claim was supported by strong scientific evidence. Vague, emotive and non-clinical claims were significantly more often supported by non-Medline or irrelevant references than unambiguous claims. Statistical parameters were stated only 34 times.

CONCLUSION

Referenced marketing claims may appear more scientific, but the use of references does not guarantee the quality of the claims. For the benefit of all stakeholders, both the regulatory control and industry's self-control of drug marketing should adopt more active monitoring roles, and apply sanctions when appropriate. Concerted efforts by several stakeholders might be more effective.

摘要

目的

记录处方药广告中营销声明的证据质量,以促进识别质量改进的潜在目标。

方法

抽取2002年在芬兰四大医学期刊上发表的1036则广告作为样本。营销声明分为四组:明确的临床结果、模糊的临床结果、情感或不可测量的结果以及非临床结果。追溯Medline参考文献并根据现有证据水平进行分类。还记录了广告中使用的统计变量。

结果

该样本包括245则不同的广告,有883条营销声明,每则广告有1至10条声明。其中337条(38%)声明有参考文献支持。每条声明可由一条或多条参考文献支持,因此分析的参考文献总数为381条,每则广告有1至9条参考文献。9%的声明暗示明确的临床结果,68%包含模糊或情感性表述。21%的参考文献与声明无关。对于73条明确的声明,有相当数量的非科学和科学支持,但没有一条声明得到有力的科学证据支持。与明确声明相比,模糊、情感性和非临床声明更常由非Medline或无关参考文献支持。仅34次提及统计参数。

结论

有参考文献支持的营销声明可能看起来更具科学性,但参考文献的使用并不能保证声明的质量。为了所有利益相关者的利益,药品营销的监管控制和行业自我控制都应发挥更积极的监测作用,并在适当的时候实施制裁。多个利益相关者的共同努力可能会更有效。

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