Mechler Konstantin, Rausch Juliane, Mountford William K, Ries Markus
Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
BMC Med Ethics. 2020 Mar 14;21(1):20. doi: 10.1186/s12910-020-0463-x.
Approximately 7% of the general population is affected by an orphan disease, which, in the United States, is defined as affecting fewer than 1 in 1500 people. Disease awareness is often low and time-to-diagnosis delayed. Different legislations worldwide have created incentives for pharmaceutical companies to develop drugs for orphan diseases. A journalistic article in Bloomberg Businessweek has claimed that pharmaceutical companies have tried marketing orphan drugs by placing a specific disease into the popular television series "House, M.D." which features diagnostic journeys and was produced between 2004 and 2012. This study aimed to describe the presentation of orphan diseases in the television series "House, M.D.", to test in an exploratory fashion the hypothesis that treatable orphan conditions are overrepresented in "House, M.D." and to discuss whether such marketing practices may or may not be ethical.
A list of all medical cases depicted in the television series "House, M.D." was obtained and classified as orphan or non-orphan according to the Orphanet database. The ratios of orphan diseases among all diseases, such with an orphan drug designation and such with an orphan drug approval by the FDA were then compared with conservative approximations of real world conditions (chi-squared tests for equality of proportions). STROBE criteria were respected.
Out of a total of n = 181 different medical diagnoses, n = 42 (23.2%) were orphan diseases. The difference in percentages in between "House, M.D." and reality was not statistically significant for orphan diseases overall (p = 0.96), yet was statistically significantly higher for both orphan diseases with one or more orphan drug designations (p = 0.0192) and such with one or more approved orphan drugs (p < 0.0001).
Orphan diseases with a designated and/or approved orphan drug were overrepresented in the television series "House, M.D." with statistical significance while orphan diseases overall were not. This may be explained by (so far) undocumented efforts of pharmaceutical companies to place their orphan drugs in the television series, as described in the article in Bloomberg Businessweek. Further research is needed into marketing practices in popular and emerging media formats.
约7%的普通人群受罕见病影响,在美国,罕见病被定义为患病人数少于1500人中的1人。疾病认知度通常较低,诊断时间往往延迟。全球不同的立法激励制药公司研发治疗罕见病的药物。彭博商业周刊的一篇新闻报道称,制药公司试图通过将特定疾病植入热门电视剧《豪斯医生》来推销罕见病药物,该剧以诊断过程为特色,于2004年至2012年制作。本研究旨在描述电视剧《豪斯医生》中罕见病的呈现情况,以探索性方式检验可治疗的罕见病在《豪斯医生》中过度呈现的假设,并讨论这种营销行为是否符合伦理道德。
获取电视剧《豪斯医生》中描绘的所有医疗病例清单,并根据《孤儿病数据库》将其分类为罕见病或非罕见病。然后将所有疾病中罕见病的比例,以及有罕见病药物指定和美国食品药品监督管理局批准的罕见病药物的比例,与现实世界情况的保守近似值进行比较(比例相等的卡方检验)。遵循加强流行病学观察性研究报告标准(STROBE)准则。
在总共n = 181种不同的医学诊断中,n = 42种(23.2%)为罕见病。总体而言,《豪斯医生》中罕见病的百分比与现实情况的差异无统计学意义(p = 0.96),但对于有一个或多个罕见病药物指定的罕见病(p = 0.0192)以及有一个或多个批准的罕见病药物的罕见病(p < 0.0001),差异具有统计学意义。
有指定和/或批准的罕见病药物的罕见病在电视剧《豪斯医生》中呈现过度,具有统计学意义,而总体罕见病并非如此。这可能如彭博商业周刊文章中所述,是制药公司(目前)未记录在案地努力将其罕见病药物植入电视剧所致。需要对流行和新兴媒体形式中的营销行为进行进一步研究。