Hastings Cent Rep. 2019 Mar;49(2):26-36. doi: 10.1002/hast.990.
Policy-makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right-to-try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right-to-try movement asserts? What is government's proper role in regulating and facilitating access to drugs that are still in development? In this review, we analyze the history of the right-to-try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement's consequences. Two possible scenarios may emerge. One is that the right-to-try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right-to-try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations.
政策制定者、生物伦理学家和患者权益倡导者就联邦尝试权法的优点和潜在危害展开了激烈的争论。这场关于获取试验性医疗产品的辩论提出了一些深刻的问题，涉及到患者自主权的界限、适当的政府监管、医疗家长主义和政治言论。例如，正如尝试权运动所主张的那样，患者是否有权获得试验性疗法？政府在监管和促进仍在开发中的药物的获取方面应发挥什么作用？在这篇综述中，我们分析了尝试权运动的历史，回顾了立法支持者和反对者提出的论点，并考虑了该运动的后果。可能会出现两种情况。一种是尝试权途径可能无法显著增加患者获得试验产品的机会。另一种情况是，某些公司可能试图利用联邦尝试权立法来销售试验性产品，利用允许直接成本的条款，因为目前没有明确的机制来执行或监测成本计算。
