Institute for Humane Studies at George Mason University, Arlington, Virginia, USA.
J Med Philos. 2020 Jan 10;45(1):61-85. doi: 10.1093/jmp/jhz028.
The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside of clinical trials would undermine evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine.
声称个人在价值观方面存在合法差异，这在伦理学家中似乎没有争议，但许多伦理学家仍然反对尝试权法。这似乎部分是由于未能认识到这些法律主要是政治而非法律工具。尝试权运动旨在为在临床试验之外获得新开发的药物建立政治支持。尝试权法的反对者声称，在临床试验之外增加获得途径会破坏循证医学。他们试图通过保护患者免受药物不良反应的影响并确保药物平均更有效，从而使患者获得最大收益。相比之下，尝试权活动家有一个观点，即药物安全性和有效性的监管判断对所有个人都施加了一套权衡，无论他们的价值观有何不同。如果安全性和有效性的判断是黑白分明的，那么这可能是可以接受的，但事实似乎并非如此。本文认为，安全性和有效性的判断在重要方面是规范性的，反映了相对于其他方面，人们对这些目的的价值的看法。当这些判断被普遍强加时，会伤害那些愿意在药物安全性和有效性知识较少的情况下，为了更多的时间和自我决定而妥协的患者。相关的道德原则是尊重个人自主权。正如该原则应该导致人们用集体决策代替个人决策来监管自然垄断一样，同样的原则也应该导致人们用个人决策代替集体决策，以避免政府对新开发药物的准入垄断。有人认为，改革应该增加临床试验之外患者可用的治疗选择数量。文章的最后一节讨论了如何改革现行法规，以便在不破坏循证医学的情况下，在临床试验之外提供更多的治疗选择。
