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公共资金支持变革性药物:以索非布韦为例。

Public funding for transformative drugs: the case of sofosbuvir.

机构信息

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA 02120, USA.

Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont St, Suite 3030, Boston, MA 02120, USA.

出版信息

Drug Discov Today. 2021 Jan;26(1):273-281. doi: 10.1016/j.drudis.2020.09.024. Epub 2020 Oct 1.

DOI:10.1016/j.drudis.2020.09.024
PMID:33011345
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7528745/
Abstract

The approval of sofosbuvir (Sovaldi) in 2013 transformed chronic hepatitis C virus (HCV) care, but its high cost was criticized in part because of reports of substantial public involvement in its development. We developed a methodology to assess the public's contribution through the National Institutes of Health (NIH) in developing sofosbuvir. Using key terms from the timeline of sofosbuvir, we identified articles in PubMed; linked them to federal funding using the NIH RePORTER; reviewed the title, organization, and investigator of each resulting award for relatedness; and converted related awards to 2018 US dollars. Of 6043 unique awards, we identified 29 that were directly (US$7.7 million) and 110 that were indirectly (US$53.2 million) related awards made to major academic institutions and companies engaged in the development of the drug. These findings indicate that public funding had a key role in developing sofosbuvir, with an estimated US$60.9 million provided in NIH funding.

摘要

2013 年索非布韦(Sovaldi)的批准改变了慢性丙型肝炎病毒(HCV)的治疗方式,但由于有报道称公众在其研发过程中发挥了重要作用,其高昂的成本受到了部分批评。我们开发了一种通过美国国立卫生研究院(NIH)评估索非布韦研发过程中公众贡献的方法。我们使用了索非布韦时间表中的关键术语,在 PubMed 中识别出相关文章;通过 NIH RePORTER 将它们与联邦资金联系起来;根据相关性,对每个相关奖励的标题、组织和研究者进行了审查;并将相关奖励转换为 2018 年的美元。在 6043 个独特的奖励中,我们确定了 29 个直接(770 万美元)和 110 个间接(5320 万美元)与主要学术机构和参与药物开发的公司相关的奖励。这些发现表明,公共资金在索非布韦的研发中发挥了关键作用,NIH 提供了约 6090 万美元的资金。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b810/7528745/2d77ada9dcf0/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b810/7528745/6bec84bfc762/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b810/7528745/2d77ada9dcf0/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b810/7528745/6bec84bfc762/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b810/7528745/2d77ada9dcf0/gr2_lrg.jpg

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本文引用的文献

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Public sector financial support for late stage discovery of new drugs in the United States: cohort study.美国公共部门对新药后期发现的财政支持:队列研究。
BMJ. 2019 Oct 23;367:l5766. doi: 10.1136/bmj.l5766.
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Contribution of NIH funding to new drug approvals 2010-2016.NIH 资助对 2010-2016 年新药批准的贡献。
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Do Health Technology Assessment organisations consider manufacturers' costs in relation to drug price? A study of reimbursement reports.卫生技术评估组织在确定药品价格时会考虑制造商的成本吗?一项关于报销报告的研究。
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Betting on hepatitis C: how financial speculation in drug development influences access to medicines.押注丙型肝炎:药物研发中的金融投机如何影响药物可及性。
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Discovery and Development of the Anti-Human Immunodeficiency Virus Drug, Emtricitabine (Emtriva, FTC).发现与研制抗人类免疫缺陷病毒药物恩曲他滨(恩曲他滨,FTC)。
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Ralf Bartenschlager, Charles Rice, and Michael Sofia are honored with the 2016 Lasker~DeBakey Clinical Medical Research Award.拉尔夫·巴滕施拉格、查尔斯·赖斯和迈克尔·索菲亚荣获2016年拉斯克~德巴基临床医学研究奖。
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