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

Content Provider	Europe PMC
Author	Hordijk, Marjolijn Vermeulen, Stefan F. Bunnik, Eline M.
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.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC9366814&blobtype=pdf
ISSN	13867423
Journal	Medicine, Health Care, and Philosophy [Med Health Care Philos]
Volume Number	25
DOI	10.1007/s11019-022-10106-y
PubMed Central reference number	PMC9366814
Issue Number	4
PubMed reference number	35951276
e-ISSN	15728633
Language	English
Publisher	Springer Netherlands
Publisher Date	2022-08-11
Publisher Place	Dordrecht
Access Restriction	Open
Rights License	Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. © The Author(s) 2022
Subject Keyword	Expanded access Compassionate use Investigational drugs Drug registration False hope Ethics.
Content Type	Text
Resource Type	Article
Subject	Philosophy Education Health (social science) Health Policy