When seriously ill patients reach the end of the standard treatment trajectory for their condition, they may qualify for the use of unapproved, investigational drugs regulated via expanded access programs. In medical-ethical discourse, it is often argued that expanded access to investigational drugs raises ‘false hope’ among patients and is therefore undesirable. We set out to investigate what is meant by the false hope argument in this discourse. In this paper, we identify and analyze five versions of the false hope (...) argument which we call: (1) the limited chance at benefit argument, (2) the side effects outweighing benefits argument, (3) the opportunity costs argument, (4) the impossibility of making informed decisions argument, and (5) the difficulty of gaining access argument. We argue that the majority of these five versions do not provide normative ground for disqualifying patients’ hopes as false. Only when hope is rooted in a mistaken belief, for example, about the likelihood of benefits or chances on medical risks, or when hope is directed at something that cannot possibly be obtained, should it be considered false. If patients are adequately informed about their odds of obtaining medical benefit, however small, and about the risks associated with an investigational treatment, it is unjustified to consider patients’ hopes to be false, and hence, to deny them access to investigational drug based on that argument. (shrink)

Accelerated approval of aducanumab for mild Alzheimer's by the U.S. Food and Drug Administration on June 7, 2021, has generated substantial medical, scientific, and ethical controversy. That approval was contrary to the nearly unanimous judgment of the FDA's Advisory Committee that little reliable evidence existed of significant benefit, even though the drug did reduce β‐amyloid. Three major ethical problems were created by this approval: (1) Medicare resources would be unjustly squandered, given the drug's $56,000 annual price and the 3.1 million (...) older potential American patients needing the drug; (2) physicians will feel ethically compelled to provide the drug to desperate, insistent patients, given FDA approval and in spite of side effects of brain bleeds and brain swelling; (3) and false hopes are generated for patients. A needed corrective by the federal government would reduce reimbursement to the bare cost of producing the drug (plus only a modest profit) until a phase IV trial has been successfully completed. (shrink)

Artificial intelligence (AI) technologies in medicine are gradually changing biomedical research and patient care. High expectations and promises from novel AI applications aiming to positively impact society raise new ethical considerations for patients and caregivers who use these technologies. Based on a qualitative content analysis of semi-structured interviews and focus groups with healthcare professionals (HCPs), patients, and family members of patients with Parkinson’s Disease (PD), the present study investigates participant views on the comparative benefits and problems of using human versus (...) AI predictive computer vision health monitoring, as well as participants’ ethical concerns regarding these technologies. Participants presumed that AI monitoring would enhance information sharing and treatment, but voiced concerns about data ownership, data protection, commercialization of patient data, and privacy at home. They highlighted that privacy issues at home and data security issues are often linked and should be investigated together. Findings may help technologists, HCPs, and policymakers determine how to incorporate stakeholders’ intersecting but divergent concerns into developing and implementing AI PD monitoring tools. (shrink)

Despite the frequent invocation of ‘false hope’ and possible related moral concerns in the context of assisted reproduction technologies, a focused ethical and conceptual problematisation of this concept seems to be lacking. We argue that an invocation of ‘false hope’ only makes sense if the fulfilment of a desired outcome (eg, a successful fertility treatment) is impossible, and if it is attributed from an external perspective. The evaluation incurred by this third party may foreclose a given perspective from being an (...) object of hope. However, this evaluation is not a mere statistical calculation or observation based on probabilities but is dependent on several factors that should be acknowledgeable as morally relevant. This is important because it allows room for, and encourages, reasoned disagreement and moral negotiation. Accordingly, the object of hope itself, whether or not based on socially embedded desires or practices, can be a topic of debate. (shrink)