Zettler Patricia J
Center for Law, Health & Society, Georgia State University College of Law, Atlanta, GA, USA.
EMBO Mol Med. 2015 Oct;7(10):1248-50. doi: 10.15252/emmm.201505262.
In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include more specific criteria for authorizing compassionate use. But even where regulatory agencies make decisions based on clear rules, difficult questions will arise.
除了是再生医学方面未经证实的炒作案例外,围绕总部位于意大利的耐力基金会未经证实的干细胞疗法的争议,代表了关于如何平衡患者尽早获得实验性药物的需求与证明安全性和有效性要求的持续辩论中的又一章。根据意大利法律,耐力疗法的同情使用按理说不应被允许,但公众压力巨大,法官最终批准了使用。这些事件带来的一个教训是,专业监管机构可能是最有能力做出同情使用决定的机构,政策应包括更具体的同情使用授权标准。但即使监管机构根据明确规则做出决定,难题仍会出现。