Department of English Language & Literatures and Graduate Program in Science and Technology Studies, The University of British Columbia, Vancouver, BC, Canada.
Soc Stud Sci. 2018 Aug;48(4):459-482. doi: 10.1177/0306312718778802. Epub 2018 Jun 3.
In August, 2015, the US Food and Drug Administration approved Addyi (flibanserin) for the treatment of Hypoactive Sexual Desire Disorder in premenopausal women. Ten months before that, the FDA had held a Patient-Focused Drug Development Public Meeting to address the 'unmet need' for a pharmaceutical to treat that condition. I attended that meeting as a rhetorical observer. This essay is an account of persuasive strategies used on, and then by, the FDA, as it considered approving a drug that was not convincingly either safe or effective. The essay turns on three texts: the 'Even the Score' pro-drug campaign that informed the patient-focused meeting, the text of the meeting itself, and the FDA's own published report of the event. I describe how a pharmaceutical company (Sprout, then owners of flibanserin) recruited, and then ventriloquized, both health professionals and members of the public to pressure the FDA to approve a sex drug for women - claiming that not to do so was evidence of sexism. I argue, with rhetorical evidence, that the case for approving flibanserin had already been won before Sprout submitted its application.
2015 年 8 月,美国食品和药物管理局批准 Addyi(氟班色林)用于治疗绝经前妇女的低性欲障碍。在此之前的 10 个月,FDA 举行了一次以患者为中心的药物开发公开会议,以解决治疗这种疾病的药物的“未满足需求”。我作为修辞观察员出席了那次会议。本文讲述了 FDA 在考虑批准一种既不安全也没有明显疗效的药物时所使用的说服策略。本文围绕三个文本展开:“平等对待”(Even the Score)支持该药物的宣传活动,会议本身的文本,以及 FDA 对该事件的公开报告。我描述了一家制药公司(Sprout,当时拥有氟班色林)如何招募并操纵卫生专业人员和公众向 FDA 施压,要求批准一种女性性药物——声称不这样做就是性别歧视的证据。我用修辞证据来论证,在 Sprout 提交申请之前,批准氟班色林的理由已经成立。