Pharmaceuticals and Cancer

描述（由申请人提供）：越来越多的儿童和成人定期服药，但相对较少的药物在上市后进行了重大的不良反应监测，包括癌症发病率升高。我们最初资助的提案的主要目的是确定与较低或较高癌症发病率相关的常用处方药，并检查这些关联是否值得进一步研究。这项研究是在北加州凯撒医疗机构（KPNC）内进行的，这是一个预付费的综合健康计划，目前有超过320万活跃会员。我们对230种最常用的处方药（1994-2003年间至少有30,000名患者）进行了监测分析（即假设生成），特别关注了我们之前的药物致癌性监测计划中未检查的115种药物，以及对药物-癌症关联的一些更深入的分析（即假设检验）。在此续期申请中，我们请求资金继续监测常用处方药的致癌性，并检查选定的潜在重要性的药物-癌症关联。此更新申请建立在自20世纪70年代末以来在KPNC内进行的药物监测计划的基础上。具体来说，我们建议：1)继续监测常用处方药的可能致癌作用（即，假设生成）自1994年以来计算机存储的药房记录的KPNC成员，2)对上述筛选分析或从人类或动物研究报告中发现的选定药物-癌症关联进行研究（即，假设检验）。在更新的日历期间，我们的200多万会员将被开一种或多种药物，每年约有18,000名会员被诊断患有癌症，在研究期间（1994-2013），会员中诊断出的癌症总数约为32万。KPNC的成员资格和数据库继续为大量处方药的可能致癌作用的成本效益监测和对特定药物-癌症关联的更深入研究提供独特的资源。会员人数众多，稳定，种族多样，几乎所有的医疗保健都来自预付费的综合医疗保健计划。硬拷贝和电子医疗记录可提供有关处方药物，癌症诊断，实验室检查，门诊就诊和住院的信息。公共卫生相关性：新药开发继续快速发展，在美国，定期服用一种或多种药物的儿童和成人比例不断增加。然而，尽管公众和科学界越来越担心潜在的健康风险，但对常用处方药的副作用（包括提高癌症发病率）的监测相对较少。北加州Kaiser Permanente监测项目旨在检测与常用处方药相关的潜在癌症风险信号，并对特定药物进行更深入的调查。我们的项目提供了一种有价值的机制来识别最常用药物可能致癌作用的早期迹象，或在这方面保证其安全性。

DESCRIPTION (provided by applicant): A growing proportion of children and adults take medication regularly, yet relatively few drugs have undergone significant post-marketing surveillance for adverse effects, including elevated cancer rates. The main objective of our originally funded proposal was to identify commonly prescribed drugs that are associated with lower or higher rates of cancer and examine whether these associations deserved further study. The study was conducted within Kaiser Permanente of Northern California (KPNC), a prepaid, integrated health plan with over 3.2 million currently active members. We conducted surveillance analyses (i.e., hypothesis generating) of the 230 most commonly prescribed drugs (at least 30,000 recipients from 1994-2003) with a special focus on the 115 drugs not examined in our previous program of surveillance of drugs for carcinogenicity, as well as several more in-depth analyses of drug-cancer associations (i.e., hypothesis testing). In this Renewal application, we are requesting funding to continue our surveillance of commonly prescribed drugs for carcinogenicity, as well as to examine selected drug-cancer associations of potential importance. This Renewal application builds on a drug surveillance program conducted within KPNC since the late 1970s. Specifically, we propose to: 1) Continue surveillance of commonly used prescription drugs for possible carcinogenic effects (i.e., hypothesis generation) among KPNC members with computer-stored pharmacy records since 1994, and 2) Conduct studies of selected drug-cancer associations found in the above screening analyses or from reports of human or animal studies (i.e., hypothesis testing). During the calendar period of the Renewal over two million of our members will be prescribed one or more drugs and approximately 18,000 members will be diagnosed with cancer per year for a total of approximately 320,000 cancers diagnosed among members during the period of study (1994-2013). The KPNC membership and databases continue to provide a unique resource for cost-efficient surveillance of a large number of prescription drugs for possible carcinogenic effects and for more in-depth studies of specific drug-cancer associations. The membership is large, stable, ethnically diverse, and receives virtually all of its health care from the pre-paid, integrated medical care program. Hard copy and electronic medical records are available with information on prescribed medications, cancer diagnoses, laboratory tests, and outpatient visits and hospitalizations. PUBLIC HEALTH RELEVANCE: New drug development continues at a rapid pace and a growing proportion of children and adults in the US take one or more medications on a regular basis. Yet despite growing public and scientific concern about potential health risks, there has been relatively little surveillance of commonly prescribed drugs for adverse effects, including elevated cancer rates. The Kaiser Permanente of Northern California surveillance program has been designed to detect signals of potential cancer risk associated with commonly prescribed drugs and to conduct more in-depth investigations of specific medications. Our program provides a valuable mechanism to identify early signs of possible carcinogenic effects of the most commonly used medications or reassurance as to their safety in this regard.