A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises

Corrigan, Oonagh

doi:10.1016/s0277-9536(01)00183-6

Cited by 71 publications

(33 citation statements)

References 12 publications

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“…Since the 1960s, US and UK regulators have stipulated that all new medicines must be tested for efficacy and safety through RCTs in order to earn licences, a phenomenon attracting increasing attention from social scientists interested in the rise of standardized testing and its influence on drug regulation and delivery (see, for example, Abraham, 2007;Abraham and Sheppard, 1999;Corrigan, 2002;Dehue, 2002;Lakoff, 2005Lakoff, , 2007Marks, 1997;Sunder Rajan, 2007;Timmermans, 2005;Timmermans and Berg, 2003;Vrecko, 2008;Wahlberg and McGoey, 2007;. The double-blind RCT, where neither the trial administrators nor trial participants know who is receiving the active treatment or who the control, has long been hailed as the gold standard for determining a new treatment's worth, because the use of blinding, random allocation and control groups helps to determine whether the treatment itself or an outside variable -such as the individual's physiology or an environmental factor -produces the treatment's effects.…”

Section: Antidepressant Efficacy and The Methodological Limitations Omentioning

confidence: 99%

Profitable failure: antidepressant drugs and the triumph of flawed experiments

McGoey

2010

History of the Human Sciences

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Drawing on an analysis of Irving Kirsch and colleagues' controversial 2008 article in PLoS [Public Library of Science] Medicine on the efficacy of SSRI antidepressant drugs such as Prozac, I examine flaws within the methodologies of randomized controlled trials (RCTs) that have made it difficult for regulators, clinicians and patients to determine the therapeutic value of this class of drug. I then argue, drawing analogies to work by Pierre Bourdieu and Michael Power, that it is the very limitations of RCTs -their inadequacies in producing reliable evidence of clinical effects -that help to strengthen assumptions of their superiority as methodological tools. Finally, I suggest that the case of RCTs helps to explore the question of why failure is often useful in consolidating the authority of those who have presided over that failure, and why systems widely recognized to be ineffective tend to assume greater authority at the very moment when people speak of their malfunction.

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Section: Antidepressant Efficacy and The Methodological Limitations Omentioning

confidence: 99%

Profitable failure: antidepressant drugs and the triumph of flawed experiments

McGoey

2010

History of the Human Sciences

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“…This combination of elements greatly increased the program's sensitivity relative to that of MedWatch alone. MedWatch is a program maintained by the FDA to collect adverse-event reports on marketed medications from health-care providers, drug companies, and individual consumers, and to provide safety information for health-care professionals and the public (Corrigan, 2002;Woody et al, 2003); it does not specifically target abuse or dependence as adverse events, nor does it target specific medications. In contrast, the tramadol key-informantnetwork program solicited reports of tramadol abuse at three-month intervals from drug-abuse experts (including researchers, clinicians, treatment counselors, and methadone-program directors) and conducted Internet searches for information on tramadol abuse (Cicero et al, 1999).…”

Section: Postmarketing Surveillancementioning

confidence: 99%

Abuse liability, behavioral pharmacology, and physical-dependence potential of opioids in humans and laboratory animals: Lessons from tramadol

Epstein

Preston

Jasinski

2006

Biological Psychology

124

100

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Assessment of abuse potential of opioid analgesics has a long history in both laboratory animals and humans. This article reviews the methods used in animals and in humans and then presents the data collected in the evaluation of tramadol, an atypical centrally acting opioid analgesic approved for marketing in the United States in 1998. Finally, data on the abuse of tramadol from postmarketing surveillance and case reports are presented. The consistency between animal and human study results and the predictive value of both are discussed. Overall, there was substantial agreement between animal and human data, with each having predictive value. Nonetheless, it is suggested that abusepotential screening of new medications would benefit from an organized, integrated cross-species program.

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“…Identifying drug side effects is a difficult task due to the majority of side effects relying on multiple factors, so it is common for some side effects to be observed rarely. Clinical trails are unable to identify the majority of side effects prior to marketing due to them only involving a small number of patients and being conducted under unrealistic conditions [13]. For example, patients involved in clinical trials are unlikely to take other drugs during the trial, so drug interactions can not be analysed.…”

Section: Previous Pharmacovigilancementioning

confidence: 99%

Tuning a Multiple Classifier System for Side Effect Discovery Using Genetic Algorithms

2014

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Abstract-In previous work, a novel supervised framework implementing a binary classifier was presented that obtained excellent results for side effect discovery. Interestingly, unique side effects were identified when different binary classifiers were used within the framework, prompting the investigation of applying a multiple classifier system. In this paper we investigate tuning a side effect multiple classifying system using genetic algorithms. The results of this research show that the novel framework implementing a multiple classifying system trained using genetic algorithms can obtain a higher partial area under the receiver operating characteristic curve than implementing a single classifier. Furthermore, the framework is able to detect side effects efficiently and obtains a low false positive rate.

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A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises

Cited by 71 publications

References 12 publications

Profitable failure: antidepressant drugs and the triumph of flawed experiments

Profitable failure: antidepressant drugs and the triumph of flawed experiments

Abuse liability, behavioral pharmacology, and physical-dependence potential of opioids in humans and laboratory animals: Lessons from tramadol

Tuning a Multiple Classifier System for Side Effect Discovery Using Genetic Algorithms

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