Stryer D, Bero L A
Kayenta Health Center, Indian Health Service, San Francisco, CA, USA.
J Gen Intern Med. 1996 Oct;11(10):575-83. doi: 10.1007/BF02599024.
To describe material distributed to physicians by pharmaceutical companies; to describe characteristics of the drugs discussed in the material; to determine whether the material complies with Food and Drug Administration (FDA) regulations and whether it contains promotional and educational characteristics.
Cross-sectional study.
An academic internal medicine residency program, a private internist's office, and a health maintenance organization (HMO).
PATIENTS/PARTICIPANTS: A consecutive sample of 486 items, excluding gifts and drug samples, distributed by drug companies between August 11, 1993 and March 1, 1994.
Of the 486 items collected, 207 were reprints, 196 were advertisements, 51 were general information, and 32 were other. Reprints were delivered to residents significantly more often than to the HMO (p < .001) or to the private internist's office (p < .001). By contrast, the internist's office received a greater proportion of personal correspondence compared with the other locations (p < .001 for both). Of the drugs publicized, 10] were substantial improvements over other therapeutic choices. Forty-two percent of the items failed to comply with at least one of three FDA regulations assessed, including 17 items that discussed unapproved uses for drugs. Advertisements, as well as items that were not obviously promotional, contained promotional characteristics. Thirty-nine percent of the items offered scientific support for their claims.
Little of the material distributed by pharmaceutical companies to physicians conveys information about important therapeutic breakthroughs; some of it fails to comply with FDA regulations. The material contains both educational and promotional characteristics.
描述制药公司向医生分发的资料；描述资料中所讨论药物的特征；确定这些资料是否符合美国食品药品监督管理局（FDA）的规定，以及是否具有促销和教育性质。
横断面研究。
一个学术性内科住院医师培训项目、一个私人内科医生办公室和一个健康维护组织（HMO）。
患者/参与者：1993年8月11日至1994年3月1日期间制药公司分发的486份物品的连续样本，不包括礼品和药品样本。
在收集的486份物品中，207份是重印件，196份是广告，51份是一般信息，32份是其他类型。重印件分发给住院医师的频率明显高于HMO（p < 0.001）或私人内科医生办公室（p < 0.001）。相比之下，内科医生办公室收到的私人通信比例高于其他地点（两者p均 < 0.001）。在宣传的药物中，101种相比其他治疗选择有实质性改进。42%的物品至少不符合评估的三项FDA规定中的一项，其中17项讨论了药物的未批准用途。广告以及并非明显具有促销性质的物品都具有促销特征。39%的物品为其声称的内容提供了科学支持。
制药公司向医生分发的资料中，很少有传达重要治疗突破信息的；有些资料不符合FDA规定。这些资料兼具教育和促销性质。
