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The ethics of innovation for Alzheimer’s disease: the risk of overstating evidence for metabolic enhancement protocols
Theoretical Medicine and Bioethics ( IF 1.1 ) Pub Date : 2021-01-18 , DOI: 10.1007/s11017-020-09536-7
Timothy Daly 1 , Ignacio Mastroleo 2 , David Gorski 3 , Stéphane Epelbaum 4
Affiliation  

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer’s disease has motivated “innovative practice” to improve patients’ well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer’s disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer’s disease.



中文翻译:

阿尔茨海默病创新伦理:夸大代谢增强方案证据的风险

理想情况下,医疗实践基于强大的相关研究。然而,尽管没有足够的证据表明在治疗数百万患者的卫生系统中定期使用此类干预措施,但由于缺乏针对阿尔茨海默病的疾病改善疗法,这激发了“创新实践”以改善患者的福祉。创新的或新的未经验证的实践至少提出了三个不同的伦理问题:第一,关于负责任地将新的未经验证的实践应用于个体患者(临床伦理);第二,关于来自新的未经验证的实践的数据通过科学和非专业媒体传播的方式(科学传播伦理);第三,关于在更明确的测试(公共卫生伦理)之前广泛提供新的未经验证的干预措施的前景。我们认为,阿尔茨海默病代谢增强方案的作者在科学和非专业媒体中夸大了支持这些干预措施的证据,未能传达他们数据中的弱点和结论的不确定性。这种无法衡量的语言可能会产生虚假的希望,造成经济损失,破坏知情同意,并阻碍应对这种破坏性疾病带来的社会问题所必需的可推广知识的产生。因此,我们为阿尔茨海默病治疗的负责任创新提供了更严格的指导方针。这种无法衡量的语言可能会产生错误的希望,造成经济损失,破坏知情同意,并阻碍应对这种破坏性疾病带来的社会问题所必需的可推广知识的产生。因此,我们为阿尔茨海默病治疗的负责任创新提供了更严格的指导方针。这种无法衡量的语言可能会产生错误的希望,造成经济损失,破坏知情同意,并阻碍应对这种破坏性疾病带来的社会问题所必需的可推广知识的产生。因此,我们为阿尔茨海默病治疗的负责任创新提供了更严格的指导方针。

更新日期:2021-01-19
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