Boesen Kim, Simonsen Anders Lykkemark, Jørgensen Karsten Juhl, Gøtzsche Peter C
Nordic Cochrane Centre, Rigshospitalet Dept. 7811, 2100 Copenhagen, Denmark.
Current address: Meta Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Charité Universitätsmedizin, QUEST Center for Transforming Biomedical Research, Berlin, Germany.
Res Integr Peer Rev. 2021 May 10;6(1):8. doi: 10.1186/s41073-021-00111-9.
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.
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.
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.
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.
医疗保健专业人员会接触到医学期刊上的处方药广告。即使这些新药没有额外益处、危害更大且价格更高,此类广告也可能会增加新药的处方量,而牺牲旧有治疗方法的使用。因此,医学广告的发布引发了与编辑诚信相关的伦理问题。
我们对2015年发表在《丹麦医学协会杂志》上的所有医学广告进行了描述性横断面研究。将广告次数达到或超过6次的药物与其旧有对照药物进行比较:(1)额外益处的比较证据;(2)限定日剂量成本;(3)监管安全公告;(4)广告发布3年后完成的和正在进行的上市后研究。
我们发现2015年期间在24期杂志上发表了158则针对35种处方药的医学广告,每期广告中位数为7则(范围为0至11则)。有4个药物类别和5种单一药物的广告次数达到或超过6次,共涉及10种适应症,我们与旧有治疗方法进行了14次比较。我们发现:(1)在14次比较中,4次(29%)为“无额外益处”,7次(50%)为“益处不确定”,3次(21%)为“无证据”。在任何一次比较中,我们都未发现新药有“显著额外益处”的证据;(2)广告药物的每限定日剂量价格比对照药物贵2至196倍(中位数为6倍);(3)针对5种广告药物发布了11条安全公告,而针对1种对照药物仅发布了1条公告;(4)针对广告药物要求进行20项上市后研究(7项已完成,13项正在进行),而针对对照药物要求进行10项研究(4项已完成,6项正在进行),并且在3年随访时有7项研究(2项已完成,5项正在进行)同时评估了一种广告药物和一种对照药物。
在这项对2015年发表在《丹麦医学协会杂志》上的医学广告的横断面研究中,广告最多的药物相较于旧有治疗方法并未有记录显示具有显著额外益处,但其价格却要高得多。自2021年1月起,《丹麦医学协会杂志》不再刊登医学广告。