The ethics of innovation for Alzheimer’s disease
By Timothy Daly, Ignacio Mastroleo, David Gorski, Stéphane Epelbaum
Keywords: Biomedical ethics Alzheimer's disease Integrative medicine Clinical ethics Dementia Innovation Diffusion of innovation
In this article we describe the interplay between a chronic disease with severe therapeutic unmet need such as Alzheimer and innovation. Caveats and ethical guidelines are discussed herein.
Innovation and Alzheimer. Friend or foe ?
Full title The ethics of innovation for Alzheimer's disease: the risk of overstating evidence for metabolic enhancement protocols
Medical practice is ideally based on robust, relevant research. However, the lack of diseasemodifying 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.