ABSTRACT This article may be used for research, teaching, and private study purposes. Any substan... more ABSTRACT This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. The publisher does not give any warranty express or implied or make any representation that the contents will be complete or accurate or up to date. The accuracy of any instructions, formulae, and drug doses should be independently verified with primary sources. The publisher shall not be liable for any loss, actions, claims, proceedings,
The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn a... more The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine , and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.
Context: Quantitative estimates of the magnitude, direction, and rate of change of health inequal... more Context: Quantitative estimates of the magnitude, direction, and rate of change of health inequalities play a crucial role in creating and assessing policies aimed at eliminating the disproportionate burden of disease in disadvantaged populations. It is generally assumed that the measurement of health inequalities is a value-neutral process, providing objective data that are then interpreted using normative judgments about whether a particular distribution of health is just, fair, or socially acceptable.Methods: We discuss five examples in which normative judgments play a role in the measurement process itself, through either the selection of one measurement strategy to the exclusion of others or the selection of the type, significance, or weight assigned to the variables being measured.Findings: Overall, we find that many commonly used measures of inequality are value laden and that the normative judgments implicit in these measures have important consequences for interpreting and responding to health inequalities.Conclusions: Because values implicit in the generation of health inequality measures may lead to radically different interpretations of the same underlying data, we urge researchers to explicitly consider and transparently discuss the normative judgments underlying their measures. We also urge policymakers and other consumers of health inequalities data to pay close attention to the measures on which they base their assessments of current and future health policies.
ABSTRACT This article may be used for research, teaching, and private study purposes. Any substan... more ABSTRACT This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. The publisher does not give any warranty express or implied or make any representation that the contents will be complete or accurate or up to date. The accuracy of any instructions, formulae, and drug doses should be independently verified with primary sources. The publisher shall not be liable for any loss, actions, claims, proceedings,
The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn a... more The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine , and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.
Context: Quantitative estimates of the magnitude, direction, and rate of change of health inequal... more Context: Quantitative estimates of the magnitude, direction, and rate of change of health inequalities play a crucial role in creating and assessing policies aimed at eliminating the disproportionate burden of disease in disadvantaged populations. It is generally assumed that the measurement of health inequalities is a value-neutral process, providing objective data that are then interpreted using normative judgments about whether a particular distribution of health is just, fair, or socially acceptable.Methods: We discuss five examples in which normative judgments play a role in the measurement process itself, through either the selection of one measurement strategy to the exclusion of others or the selection of the type, significance, or weight assigned to the variables being measured.Findings: Overall, we find that many commonly used measures of inequality are value laden and that the normative judgments implicit in these measures have important consequences for interpreting and responding to health inequalities.Conclusions: Because values implicit in the generation of health inequality measures may lead to radically different interpretations of the same underlying data, we urge researchers to explicitly consider and transparently discuss the normative judgments underlying their measures. We also urge policymakers and other consumers of health inequalities data to pay close attention to the measures on which they base their assessments of current and future health policies.
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