媒体对草药临床试验中利益冲突的描述。

Health law review Pub Date : 2006-01-01 DOI:10.7939/R3M00F
M. Koper, T. Bubela, T. Caulfield, H. Boon
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引用次数: 5

摘要

补充和替代医学(CAM)包括各种各样的治疗方法,例如草药疗法,目前还不被认为是主流医学的一部分。我们的研究重点是草药疗法,因为它们的使用很重要,而且越来越多。(1)我们质疑媒体对草药临床试验中利益冲突的报道是否具有足够的质量,能够为公众提供信息,从而做出理性、知情和低风险的决策。我们知道CAM通过大众媒体提供的大量信息质量参差不齐。近年来,科学界对草药疗法的研究越来越感兴趣。(3)由于利益冲突一直是合成药物试验的一个问题,特别是那些接受行业资助的合成药物试验,我们有理由相信,这也将适用于草药的临床试验,其中许多是由行业资助的。什么是利益冲突,我们为什么感兴趣?在他深思熟虑且被广泛接受的分析中,汤普森将利益冲突定义为“一组条件,在这些条件下,有关主要利益(如病人的福利或研究的有效性)的专业判断往往受到次要利益(如经济利益)的不当影响。”(4)他还指出,虽然次要利益本身通常不是不合法的,但它在专业决策中的相对权重是有问题的。因此,目标是防止次要利益“在专业决策中支配或似乎支配相关的主要利益”,而不是完全减少或消除次要利益。(5)利益冲突规则,即规范利益冲突披露和避免的规则,一般侧重于财务收益,因为它相对客观,更容易通过公正的规则进行监管。然而,这并不意味着经济利益比其他次要利益具有更大的潜在危害。(6)利益冲突和偏见之间的微妙区别也必须强调。公开的冲突只应被视为一种可能产生偏见的联系,而不是偏见本身的迹象。(7)也有人指出,如果一种联想确实损害了一个人的判断,那通常是无意识偏见的结果,而不是完全不诚实的结果。(8)由于次要利益的影响可能极其微妙,偏见的存在往往难以确定。为什么这些问题在媒体环境中很重要?由于大众媒体经常被引用为公众医学信息的主要来源,它有能力塑造公众对新医学研究的看法和解释。(9)因此,媒体报道有能力塑造公众对特定草药的安全性和有效性的看法,从而影响使用方式。我们分析的目的是推断大众媒体对草药临床试验的报道如何受到科学和医学文献中资金信息披露和竞争利益(即冲突的感知)的影响。方法:我们使用编码框架分析来检查草药临床试验中利益冲突的媒体报道。这种技术使我们能够系统地将报纸文章与医学文献中相同试验的报道进行比较。我们比较了389篇(来自美国、英国和加拿大)报道草药临床试验的报纸文章与58篇医学文献中报道的临床试验。首先,我们评估了基调、疗效声明、风险报告、资金信息和竞争利益的披露。我们的编码框架使我们能够汇编关于发表日期和地点、作者、描绘的利益和风险的可能性、利益冲突的披露、资助信息的披露和资助机构的参与、文章是否被框定为有争议的,以及报纸文章和医学杂志临床试验报告的总体基调等信息。...
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Media portrayal of conflicts of interest in herbal remedy clinical trials.
Complementary and Alternative Medicine (CAM) encompasses a wide variety of treatments, such as herbal remedies, not currently thought to be part of mainstream medicine. Our study focuses on herbal remedies, as their use is significant and increasing. (1) We ask whether media coverage of conflicts of interest in clinical trials of herbal remedies is of sufficient quality to provide the public with information to make decisions that are rational, well-informed, and low-risk. We know that the vast quantity of information available on CAM through popular media is of varying quality. (2) In recent years, the scientific community is increasingly interested in studying herbal remedies. (3) As conflict of interest has been an issue in synthetic drug trials, especially those receiving funding from industry, we have reason to believe that this will also be true of clinical trials of herbal remedies, many of which are industry funded. What is conflict of interest and why are we interested? In his thoughtful and widely accepted analysis, Thompson defined conflict of interest as "a set of conditions in which professional judgement concerning a primary interest (such as a patient's welfare or validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)." (4) He also noted that, while a secondary interest is usually not illegitimate in itself, its relative weight in professional decision-making is problematic. The goal, therefore, is to prevent secondary interests "from dominating or appearing to dominate the relevant primary interest in the making of professional decisions", rather than to reduce or eliminate them completely. (5) Conflict of interest rules, those regulating the disclosure and avoidance of these conflicts, generally focus on financial gain because it is relatively objective and easier to regulate by impartial rules. This does not mean, however, that financial gain has a greater potential for harm than other secondary interests. (6) The subtle distinction between conflict of interest and bias must also be emphasized. A declared conflict should merely be seen as an association creating the potential for bias, rather than an indication of bias itself. (7) It has also been noted that if an association does compromise one's judgment, it is generally a result of unconscious bias rather than outright dishonesty. (8) Because the influence of secondary interests can be extremely subtle, the presence of bias is often difficult to determine with any degree of certainty. Why are these issues important in a media context? As the popular press is often cited as a prominent source of medical information for the general public, it has the ability to shape public views and interpretations of new medical research. (9) It follows that media reporting has the capacity to shape public perceptions of safety and efficacy of a particular herbal remedy, thereby influencing patterns of use. The goal of our analysis is to infer how reporting of herbal remedy clinical trials by the popular media may be influenced by the disclosure of funding information and competing interests (i.e., the perception of a conflict) in the scientific and medical literature. Approach We used a coding frame analysis to examine the media coverage of conflicts of interest in clinical trials of herbal remedies. (10) This technique allowed us to systematically compare newspaper articles to the reporting of the same trials in the medical literature. We compared 389 newspaper articles (from the U.S., U.K. and Canada) reporting on herbal remedy clinical trials with the reporting of the 58 clinical trials in the medical literature. Primarily, we assessed tone, claims of efficacy, reporting of risk, and the disclosure of funding information and competing interests. Our coding frame allowed us to compile information regarding the date and location of publication, authorship, the portrayed likelihood of benefits and risks, disclosure of conflicts of interest, disclosure of funding information and funding agency involvement, whether the article was framed as a controversy, and overall tone in both newspaper articles and medical journal reports of clinical trials. …
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