The Therapeutic Misconception at 25: Treatment, Research, and Confusion

Kimmelman, Jonathan

doi:10.1353/hcr.2007.0092

Cited by 90 publications

(54 citation statements)

References 34 publications

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“…However, there is considerable evidence that potential participants frequently fail to fully understand the state of evidence and how it justifies the activities and procedures to which they are consenting. 74 Providing existing risk-benefit data, an Accumulating Evidence and Research Organization graph, study trends, or time-to-publication information for potential research participants as they contemplate enrolling in a trial would help participants' understanding, enhancing their capacity to make an informed decision. This information This approach to mapping a research portfolio also accords well with the recent recognition from the US National Heart, Lung, and Blood Institute on the need to focus its funding on questions of high social value.…”

Section: Discussionmentioning

confidence: 99%

Success, Failure, and Transparency in Biomarker-Based Drug Development

Hey

Franklin

Avorn

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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Background-Although biomarkers are used as surrogate measures for drug targeting and approval and are generally based on plausible biological hypotheses, some are found to not correlate well with clinical outcomes. Over-reliance on inadequately validated biomarkers in drug development can lead to harm to trial subjects and patients and to research waste. To shed greater light on the process and ethics of biomarker-based drug development, we conducted a systematic portfolio analysis of cholesterol ester transfer protein inhibitors, a drug class designed to improve lipid profiles and prevent cardiovascular events. Despite years of development, no cholesterol ester transfer protein inhibitor has yet been approved for clinical use. Methods and Results-We searched PubMed and Clinicaltrials.gov for clinical studies of 5 known cholesterol ester transfer protein inhibitors: anacetrapib, dalcetrapib, evacetrapib, TA-8995, and torcetrapib. Published reports and registration records were extracted for patient demographic characteristics and study authors' recommendations of clinical usage or further testing. We used Accumulating Evidence and Research Organization graphing to depict the portfolio of research activities and a Poisson model to examine trends. We identified 100 studies for analysis that involved 96 944 human subjects. The data from only 41 201 (42%) of the human subjects had been presented in a published report. For the 3 discontinued cholesterol ester transfer protein inhibitors, we found a pattern of consistently positive results on lipidmodification end points followed by negative results using clinical end points. Conclusions-Inefficiencies and harms can arise if a biomarker hypothesis continues to drive trials despite successive failures. Regulators, research funding bodies, and public policy makers may need to play a greater role in evaluating and coordinating biomarker-driven research programs. (Circ Cardiovasc Qual Outcomes. 2017;10:e003121.

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Section: Discussionmentioning

confidence: 99%

Success, Failure, and Transparency in Biomarker-Based Drug Development

Hey

Franklin

Avorn

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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“…Finally, the ultimate question of the ethical significance of TM has been thoroughly discussed and debated as well, with some commentators arguing that the laxity of definitions might lead to overheated concerns about TM [14][15][16].…”

Section: The Construct Of Therapeutic Misconceptionmentioning

confidence: 99%

When Does Therapeutic Misconception Affect Surrogates' or Subjects' Decision Making about Whether to Participate in Dementia Research?

Dunn

Palmer

2017

AMA Journal of Ethics

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Abstract"Therapeutic misconception" (TM) refers to inappropriate assumptions and beliefs on the part of research participants regarding key distinctions between the purpose, methods, intended benefits, and potential disadvantages of research compared to those of clinical care. Despite an extensive literature describing TM across varied types of research and populations, minimal work has addressed TM in the context of dementia research. This is a serious gap, for several reasons: people with dementia are at significant risk of diminished capacity; surrogate decision makers are typically asked to provide consent on behalf of the person with dementia; and available treatments for dementia are quite limited. More research is needed on the prevalence, nature, and impact of TM in the context of clinical dementia research.

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“…The classic example is known as the "therapeutic misconception," when patients participate in clinical research that also constitutes their health care and may not understand which part of the care they are receiving advances research and which treatments benefit their health (Kimmelman 2007). A similar blurring of roles occurs when immigrants visit physicians who examine their health status and simultaneously complete paperwork for legal immigration purposes.…”

Section: Misplaced Trustmentioning

confidence: 99%

Biopolitical Citizenship in the Immigration Adjudication Process

Lakhani

Timmermans²

2014

Social Problems

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JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact support@jstor.org.. University of California Press and Society for the Study of SocialProblems are collaborating with JSTOR to digitize, preserve and extend access to Social Problems.

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The Therapeutic Misconception at 25: Treatment, Research, and Confusion

Abstract: “Therapeutic misconception” has been misconstrued, and some of the newer, mistaken interpretations are troublesome. They exaggerate the distinction between research and treatment, revealing problems in the foundations of research ethics and possibly weakening informed consent.

Cited by 90 publications

References 34 publications

Success, Failure, and Transparency in Biomarker-Based Drug Development

Success, Failure, and Transparency in Biomarker-Based Drug Development

When Does Therapeutic Misconception Affect Surrogates' or Subjects' Decision Making about Whether to Participate in Dementia Research?

Biopolitical Citizenship in the Immigration Adjudication Process

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