全国性普通医学杂志上医疗广告的横断面研究:广告与比较药物的证据、成本和安全使用。

Kim Boesen, Anders Lykkemark Simonsen, Karsten Juhl Jørgensen, Peter C Gøtzsche
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引用次数: 3

摘要

背景:医疗保健专业人员接触到医学杂志上的处方药广告。这样的广告可能会增加新药的处方,而牺牲旧的治疗方法,即使它们没有额外的好处,更有害,更昂贵。因此,医疗广告的出版引发了与编辑诚信有关的伦理问题。方法:我们对2015年发表在《丹麦医学会杂志》上的所有医疗广告进行了描述性横断面研究。广告6次或6次以上的药物与较老的比较者进行比较:(1)增加获益的比较证据;(2)限定日剂量费用;(三)监管安全公告;(4)广告后3年完成并正在进行的营销后研究。结果:2015年共24期共发现35种处方药158条医疗广告,平均每期7条(范围0 ~ 11)。4个药物组和5个单一药物广告6次及以上,共10个适应症,我们与老疗法进行了14次比较。我们发现:(1)在14项比较中,有4项(29%)为“无额外益处”,7项(50%)为“不确定益处”,3项(21%)为“无证据”。在没有比较的情况下,我们没有发现新药有“实质性的额外益处”的证据;(2)广告药品每限定日剂量贵2 - 196倍(中位数6);(3) 5种药品发布11个安全公告,1种比较药发布1个安全公告;(4) 20项上市后研究(7项已完成,13项正在进行)用于广告药物,10项研究(4项已完成,6项正在进行)用于比较药物,7项研究(2项已完成,5项正在进行)在3年随访期间评估了广告药物和比较药物。结论和相关性:在2015年发表在《丹麦医学协会杂志》(Journal of the Danish medical Association)上的医疗广告的横断面研究中,广告最多的药物并没有证明比旧疗法有实质性的额外益处,相反,它们的价格要贵得多。从2021年1月起,《丹麦医学会杂志》不再刊登医疗广告。
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Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs.

Background: Healthcare professionals are exposed to advertisements for prescription drugs in medical journals. Such advertisements may increase prescriptions of new drugs at the expense of older treatments even when they have no added benefits, are more harmful, and are more expensive. The publication of medical advertisements therefore raises ethical questions related to editorial integrity.

Methods: We conducted a descriptive cross-sectional study of all medical advertisements published in the Journal of the Danish Medical Association in 2015. Drugs advertised 6 times or more were compared with older comparators: (1) comparative evidence of added benefit; (2) Defined Daily Dose cost; (3) regulatory safety announcements; and (4) completed and ongoing post-marketing studies 3 years after advertising.

Results: We found 158 medical advertisements for 35 prescription drugs published in 24 issues during 2015, with a median of 7 advertisements per issue (range 0 to 11). Four drug groups and 5 single drugs were advertised 6 times or more, for a total of 10 indications, and we made 14 comparisons with older treatments. We found: (1) 'no added benefit' in 4 (29%) of 14 comparisons, 'uncertain benefits' in 7 (50%), and 'no evidence' in 3 (21%) comparisons. In no comparison did we find evidence of 'substantial added benefit' for the new drug; (2) advertised drugs were 2 to 196 times (median 6) more expensive per Defined Daily Dose; (3) 11 safety announcements for five advertised drugs were issued compared to one announcement for one comparator drug; (4) 20 post-marketing studies (7 completed, 13 ongoing) were requested for the advertised drugs versus 10 studies (4 completed, 6 ongoing) for the comparator drugs, and 7 studies (2 completed, 5 ongoing) assessed both an advertised and a comparator drug at 3 year follow-up.

Conclusions and relevance: In this cross-sectional study of medical advertisements published in the Journal of the Danish Medical Association during 2015, the most advertised drugs did not have documented substantial added benefits over older treatments, whereas they were substantially more expensive. From January 2021, the Journal of the Danish Medical Association no longer publishes medical advertisements.

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