Department of Molecular Medicine, University of Rome La Sapienza, Rome, Italy.
EMBO J. 2013 May 29;32(11):1489-95. doi: 10.1038/emboj.2013.114. Epub 2013 May 3.
At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context-social, financial, medical, legal-in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created within science itself, and stem cell science in particular, by the currently prevailing model of 'translational medicine'. Only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients.
在撰写本文时，意大利议会正在辩论一项新法律，该法律将使公立医院实施未经证实的干细胞治疗合法化。这种治疗方法由一家私立非医疗机构提供，可能不安全，缺乏合理依据，并违反了现行的国家法律和欧洲法规。这种情况引发了诸多关注，其中最紧迫的是保护那些身患重病、面临巨大风险和易受剥削的患者。科学界必须考虑到当前干细胞科学所处的社会、经济、医疗和法律背景，以及严格监管的必要性。此外，还出现了一些新的问题。这些问题源于科学本身，特别是当前流行的“转化医学”模式，在新型气候中产生，干细胞科学也不例外。只有严谨的科学和严格的监管才能确保将科学转化为有效的疗法，而不是无效的市场产品，并同时标志着新疗法的追求与患者欺骗之间的鲜明区别。
