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 ; second, about the way in which data from new non-validated practice are communicated (...) via the scientific and lay press ; and third, about the prospect of making new non-validated interventions widely available before more definitive testing. 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. (shrink)

The brain requires sustained interaction with a rich physical and social environment to stay healthy. Individuals without access to such enabling environments and who instead live and grow in disabling environments tend to have greater risk of developing dementia. But research and policymaking as regards dementia risk reduction have so far focused almost exclusively on the role of how individuals’ health behaviors change their risk profile. This exclusive focus on “lifestyle” is both ethically problematic and therapeutically inadequate. I highlight a (...) growing literature on three different kinds of deprivation, an independent and overlooked risk factor for dementia that invites upstream action against inequalities. Future prevention guidelines should include explicit mention of deprivation as a risk factor and be developed around the need to make society fairer. Meanwhile, interventions and discourse based on lifestyle modification should respect the principle of “no ought without support.”. (shrink)

Given the past two decades of over 40 failed trials of amyloid-lowering therapies in Alzheimer’s Disease (AD), many of which succeeded in lowering amyloid as designed, we present an ethical argument for emptying the drug pipeline of tests of amyloid-lowering agents so as to end the historical dominance of the amyloid-reducing therapeutic approach in AD.

It is a tale of two Pfizers. In 2018 they abandoned research into the leading cause of dementia, Alzheimer’s Disease (AD) (Hawkes 2018). In 2021, they developed the first vaccine for Covid-19 to re...

Lynch et al.’ s work “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” is an essential c...

Recent ethics guidelines from the World Health Organization (WHO) on monitored emergency use (MEURI) state that, during a public health emergency, prospective ethical review and oversight of the use of unproven interventions outside of the context of research is an ethical principle or criterion for its permissible use. In this chapter, we argue that this new role of ethics committees in the review, authorization and oversight of emergency use outside research is a developing conceptual innovation against the background of ethics (...) documents such as the Declaration of Helsinki of the World Medical Association and the WHO earlier guidelines on “compassionate use” and MEURI. To support this claim, we offer definitions of key terms in this emerging literature and a clear methodological framework of practical analysis before presenting a literature review of relevant guidelines that focus on the presence or absence of the criterion of independent ethical review of emergency use of unproven interventions outside research. We close by discussing the future of the criterion of ethical review and oversight including questions around the greater normative complexity, both ethical and regulatory of monitored emergency use in comparison with research, the mutual influence between emergency and non-emergency use contexts, and questions of access pathways with and without committees as part of a rapidly-evolving emerging ethical literature. (shrink)