Antidepressant Use and Suicide

描述（由申请人提供）：2004年10月，美国食品和药物管理局（FDA）指示药品制造商在抗抑郁药中添加黑框警告，说明儿童自杀风险增加。FDA的裁决引发了争议，反映了在科学不确定的条件下权衡风险与收益的基本权衡。支持者认为，青少年使用抗抑郁药导致自杀风险升高的证据足够严重，有必要告知供应商和消费者。批评人士反驳说，FDA的行动将减少对抑郁症有效治疗的使用，从而在治疗不足的人群中产生更差的心理健康结果（包括对自杀风险的一些上升压力）。本申请审查了FDA监管政策的潜在收益和意外后果。与大多数先前的工作不同，这项应用的主要焦点不是抗抑郁药是否会增加自杀风险，而是存在有效治疗方法的个体患病或未治疗的风险增加。目的1评估FDA的行动对诊断为重度抑郁和焦虑的儿童和成人治疗选择的影响。目的2检查FDA的行动对接受适当治疗的儿童和成人重度抑郁症诊断的影响。目的3研究FDA行动导致的抗抑郁药使用下降对青少年药物治疗自杀企图指标的影响。目标4评估制药商是否根据FDA的行动改变了促销内容和策略。来自大量参保人群的门诊、住院和药品索赔数据将用于实施目标1-3。将对个体进行一段时间的随访，并构建治疗事件，以评估监管如何影响治疗选择和接受适当的护理。在目标4中，将采用混合方法方法来开发对制造商反应的更丰富的理解，而不是单独从定量或定性方法中确定。此应用程序的前提是预期收益和政策决策产生的意外后果的必然性。指导申请的广泛目标是促进以证据为基础的方法来理解和管理FDA监管决策中固有的不确定性。由于抑郁症治疗不足在美国是一个重大的公共卫生问题，减少抗抑郁药物治疗而不增加替代治疗并不是一个理想的政策结果。这个项目的意义在于它有可能帮助临床医生和政策制定者评估和管理相互竞争的风险和利益要求。

DESCRIPTION (provided by applicant): In October 2004, the Food and Drug Administration (FDA) directed pharmaceutical manufacturers to add a black box warning to antidepressants describing the increased risk of suicidality in children. The FDA ruling elicited controversy reflecting the fundamental trade-offs associated with weighing risks against benefits under conditions of scientific uncertainty. Supporters argued that evidence of elevated risks of suicidality linked to use of antidepressants in youth was sufficiently serious to warrant informing providers and consumers. Critics countered that FDA actions would reduce the use of an effective treatment for depression thereby producing poorer mental health outcomes (including some upward pressure on the risk of suicide) in an under-treated population. This application examines the potential gains and unintended consequences of FDA regulatory policy. Unlike most prior work, the primary focus of this application is not whether antidepressants increase suicide risk, but rather the heightened risk of individuals being under or untreated for illnesses for which effective treatments exist. Aim 1 assesses the impact of FDA actions on treatment choice for children and adults with major depression and anxiety diagnoses. Aim 2 examines the impact of FDA actions on receipt of appropriate treatment for children and adults with a major depression diagnosis. Aim 3 studies the impact of declines in antidepressant use attributable to FDA action on indicators of medically-treated suicide attempts in youth. Aim 4 assesses whether pharmaceutical manufacturers altered promotional content and strategy in response to FDA actions. Outpatient, inpatient and pharmaceutical claims data from a large insured population will be used to conduct Aims 1-3. Individuals will be followed over time and episodes of treatment will be constructed to assess how regulation affects treatment choice and receipt of appropriate care. In Aim 4, a mixed methods approach will be employed to develop a richer understanding of manufacturer response than might be ascertained from either quantitative or qualitative methods alone. This application is premised on the inevitability of both expected benefits and unintended consequences arising from policy decisions. The broad objective that guides the application is to promote an evidence-based approach to understanding and managing uncertainty inherent in FDA regulatory decisions. Because under-treatment of depression is a substantial public health problem in the U.S., reductions in antidepressant treatment unaccompanied by increases in alternative treatments is not a desirable policy outcome. The significance of this project lies in its potential to help clinicians and policymakers assess and manage competing risk and benefit claims.