| アブストラクト | Based on the Food and Drug Administration Adverse Event Reporting System (FAERS), the FDA and Hoffman La Roche issued warnings of a possible causal association between isotretinoin and inflammatory bowel disease. While scientists studied the association, trial lawyers used the courts to award large sums of money to plaintiffs despite the absence of clear scientific evidence of a causal effect. In this Issue of the Journal, a well-designed, large pharmaco-epidemiologic study shows no association. The story of isotretinoin highlights the problems that occur when the FAERS is used in litigation prior to further study and scientific analysis. |
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| ジャーナル名 | The American journal of gastroenterology |
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| 投稿日 | 2014/4/5 |
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| 投稿者 | Tenner, Scott |
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| 組織名 | Department of Gastroenterology, Downstate Medical Center, Brooklyn, New York,;USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24698863/ |
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