Castillo Pérez P
An Med Interna. 1993 May;10(5):248-56.
We start with a short introduction about the concept of "bad promotional practices" within the Pharmaceutical Industry's (PHI) communication, giving rise to the birth of so-called "un-representatives" (un'rep). Taking the self-control model from the "Association of the British Pharmaceutical Industry" (ABPI), based upon the "code of practice" as a paradigma, we comment about those who notify presumed code's breaches besides the assessment process and penalties that are usually imposed. We also considered the possibility that sometimes the physician instead of being a prosecutor is accused, by the PHI, of supposed "Medical Deonthological Code's" Infringement. The several modalities of malpraxis during the un-rep visit are classified into four categories: product un-information; unloyal competition; echonomical temptations addressed toward physicians; and disregarding stablished visit planning. We devote most of the text to exemplarize five common and very well documented situations; promotion of non-registered indications; influence of prescriptions through prebends to doctors; doubtful payments to compensate clinical trials and drug surveillance studies; the use of exagerated claims; and the abuse of the qualification "drug of choice". We end with a self-critism, from the phi's outlook on the prudence that a "good pharmaceutical communicator" must respect. As an excellent model of wisdom, we propose doctors, Because they follow the classical good-sense picture that illustrates the process of adoption of a new drug. We emphasize the fact that product over-estimation, creating false expectatives, is--together with the lak of informative liability--one of major reasons for a drug innovation to fail.
我们首先简要介绍制药行业(PHI)沟通中“不良促销行为”的概念,这导致了所谓“非代表性”(un'rep)的产生。以英国制药工业协会(ABPI)的自我控制模型为基础,以“实践准则”为范例,我们评论了那些除了评估过程和通常施加的处罚外,还通报涉嫌违反准则行为的人。我们还考虑了有时医生不是起诉方,反而被制药行业指控涉嫌违反“医学道德准则”的可能性。在非代表性拜访期间的几种不当行为方式分为四类:产品信息不充分;不正当竞争;对医生的经济诱惑;以及无视既定的拜访计划。我们在本文中大部分篇幅用于举例说明五种常见且有充分记录的情况:推广未注册适应症;通过给医生回扣影响处方;为补偿临床试验和药物监测研究而进行可疑支付;使用夸大的宣传语;以及滥用“首选药物”的称谓。我们最后从制药行业的角度进行自我批评,强调“优秀的制药沟通者”必须遵循的审慎态度。作为智慧的典范,我们推举医生,因为他们遵循说明新药采用过程的经典常识图景。我们强调产品高估、制造虚假期望,与缺乏信息责任一起,是药物创新失败的主要原因之一。