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.

中文翻译：

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国家综合医学期刊中医疗广告的横断面研究：广告药物与对比药物的证据、成本和安全使用

背景

医疗保健专业人员会在医学期刊上看到处方药广告。此类广告可能会以牺牲旧疗法为代价来增加新药处方，即使它们没有额外的好处、更有害且更昂贵。因此，医疗广告的发布引发了与编辑诚信相关的道德问题。

方法

我们对 2015 年《丹麦医学会杂志》上发表的所有医疗广告进行了一项描述性横断面研究。将广告次数达到或超过 6 次的药物与较早的对照药物进行比较：（1）增加益处的比较证据； (2) 规定的每日剂量成本； （三）监管安全公告； (4) 广告发布后 3 年内完成并正在进行的上市后研究。

结果

我们发现 2015 年 24 期刊登了 35 种处方药的 158 条医疗广告，每期中位数为 7 条广告（范围 0 到 11）。 4 个药物组和 5 个单一药物的广告次数达到或超过 6 次，总共 10 个适应症，我们与旧疗法进行了 14 次比较。我们发现：(1) 14 项比较中，有 4 项 (29%) 为“无额外益处”，7 项 (50%) 项为“不确定益处”，3 项 (21%) 比较为“无证据”。在任何比较中，我们都没有发现新药“显着增加益处”的证据； (2) 广告药品的每日规定剂量价格贵 2 至 196 倍（中位数 6）； (3) 5种已上市药品发布了11条安全公告，而1种对照药发布了1条安全公告； (4) 要求对广告药物进行 20 项上市后研究（7 项已完成，13 项正在进行），而对照药物则有 10 项研究（4 项已完成，6 项正在进行），7 项研究（2 项已完成，5 项正在进行）评估了广告药物以及 3 年随访时的对照药物。

结论和相关性

在 2015 年《丹麦医学会杂志》上发表的这项医疗广告横断面研究中，广告最多的药物并没有记录到比旧疗法有实质性的额外好处，但它们的价格却贵得多。自2021年1月起，《丹麦医学会杂志》不再刊登医疗广告。