Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated. There are several reasons explaining this difference, and all of them point to the difficulty of conducting well-designed RCTs in surgery. However, we argue that none of these arguments is decisive and that, under certain conditions, surgical RCTs can be morally justified and methodologically sound. Although ethical constraints restrict the number of testable surgical procedures, and surgical trials might not be as dependable as pharmaceutical RCTs, our analysis suggests that, in certain cases, it is possible to obtain high-quality evidence about the safety and efficacy of surgical procedures. Untested surgical treatments may prove to be ineffective and harm patients. Therefore, regulation of surgical procedures seems not only morally acceptable and able to provide reliable scientific evidence, but also desirable and justified from an ethical-political standpoint.

自 1962 年药物监管出现以来，监管机构一直在使用严格的标准来测试医疗方法和产品的安全性和有效性。FDA 等监管机构要求进行两项全面的随机临床试验，以证明药物的安全性和有效性，以授予其上市许可。相反，手术治疗完全不受监管。有多种原因可以解释这种差异，所有这些原因都表明在外科手术中进行精心设计的随机对照试验存在困难。然而，我们认为这些论点都不是决定性的，并且在某些情况下，外科随机对照试验在道德上是合理的并且在方法论上是合理的。尽管伦理约束限制了可测试外科手术的数量，和外科试验可能不像药物随机对照试验那样可靠，我们的分析表明，在某些情况下，可以获得关于外科手术安全性和有效性的高质量证据。未经检验的手术治疗可能被证明是无效的并且对患者造成伤害。因此，外科手术的监管似乎不仅在道德上可以接受并能够提供可靠的科学证据，而且从伦理政治的角度来看也是可取的和合理的。