Denial of Access as an Unmeasured Outcome in Nonprescription Statin Self-Selection Studies
· 2026-09-08 · 原文
DOI：10.64898/2026.09.06.26362346v1?rss=1
Background: Five nonprescription statin attempts have failed; a sixth attempt, under the FDA's 2025-issued Additional Condition for Nonprescription Use (ACNU) pathway, is under way. Self-selection evidence is evaluated by whether ineligible consumers are excluded; how often eligible consumers are denied has never been reported. Objective: To quantify denial of access to eligible consumers across the published self-selection record. Methods: Secondary analysis of the three published United States self-selection studies (SELECT, CREST, TACTiC), the FDA guidance, and four advisory committees' questions and votes. We recomputed diagnostic accuracy from published cross-tabulations, derived TACTiC's prespecified unmitigated endpoints, and compared access strategies by decision curve analysis. Re
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1. 人话版
Background: Five nonprescription statin attempts have failed; a sixth attempt, under the FDA's 2025-issued Additional Condition for Nonprescription Use (ACNU) pathway, is under way.
Self-selection evidence is evaluated by whether ineligible consumers are excluded; how often eligible consumers are denied has never been reported.
2. 领域脉络
Objective: To quantify denial of access to eligible consumers across the published self-selection record.
3. 机制拆解
Methods: Secondary analysis of the three published United States self-selection studies (SELECT, CREST, TACTiC), the FDA guidance, and four advisory committees' questions and votes.
We recomputed diagnostic accuracy from published cross-tabulations, derived TACTiC's prespecified unmitigated endpoints, and compared access strategies by decision curve analysis.
4. 证据与数字
摘要未给出量化结果——留意原文的实验与数据。
5. 反例与边界
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6. 跨领域连接与意外收获
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7. 可复用方法
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8. 术语表
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