The ‘false hope’ argument in discussions on expanded access to investigational drugs: a critical assessment

Abstract

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.

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

“…A combination of dire need and the glimpse of a solution may foster unrealistic expectations of medicines granted CMA among patients and families. Scholars have debated the role of hope, optimism, and realism in access to investigational drugs (32,33).…”

Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis

“…dedicated personnel) to facilitate expanded access in practice and render it more feasible. 50 Such resources required may not be available in healthcare systems already under duress. Third, there are concerns that if expanded access to investigational treatments were to become more widely accessible, patients may no longer be willing to participate in clinical trials, especially if these trials involve randomization to placebo or to a standard of care that is known to be burdensome or ineffective.…”

‘False hope’ in assisted reproduction: the normative significance of the external outlook and moral negotiation

“…Labeling this as selling 'false hope' may not accurately reflect the situation, as the desired outcome could (at high costs) still be possible, though it can be framed as instilling 'irrational hope' by exploiting the conative element. 4 Doubling back to the aspect of negotiabilitywhich we have here aimed to highlight by accentuating the external perspective in false hope attributionsthe socially embedded desires that structure objects of hope, can be questioned. Pitting alternative possibilities against shared beliefs (about which hoped-for outcomes are considered desirable and which are not) marks the negotiability of which desires are recognized as worth pursuing [13,18].…”

“…Despite the frequent invocation of this concept (and the possible moral concerns that come with it) in the context of ART, and unlike the conceptual and normative attention that has been paid to it in broader philosophical domains or other medical settings, a focused ethical and conceptual problematization of 'false hope' in the field of ART seems to be lacking. Earlier analyses have indeed offered valuable insight in the subtleties of understanding and evaluating hope (and its associate 'false hope') in clinical 3 ethics [3][4][5]. The point of our paper is, first, to explicitly explore the ethical concerns related to false hope in the specific context of ART, and second, to accentuate that 'false hope' only makes sense when it is attributed by an external source.…”

“…A similar philosophical exercise pertaining to the concept of 'hope' may, likewise, illustrate that the frequent use of this word seems to be unhindered by the challenges related to grasping its meaning. Indeed, recent and valuable work has been done in analyzing hope from a fundamental philosophical perspective [1,2] and from more applied medical-ethical perspectives [3][4][5]. When it comes to the particular context of (assisted) reproduction, notions of hope are frequently invoked, where reproductive technologies have been termed 'hope technologies' as they keep the hope alive to satisfy the desire to have a genetically related child [6,7].…”