The Experts below are selected from a list of 96 Experts worldwide ranked by ideXlab platform
David Mercer - One of the best experts on this subject based on the ideXlab platform.
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litigation life law science knowledge construction in Bendectin mass toxic tort litigation
Social Studies of Science, 2000Co-Authors: Gary Edmond, David MercerAbstract:In recent decades, large-scale product liability litigation, so-called 'mass torts', have become increasingly visible on the US legal and political landscape. Invariably, mass tort litigation incorporates a range of specialist scientific knowledges. Drawing upon fairly conventional images of law and science, most judges and legal commentators attribute the apparent difficulties encountered in addressing the refractory issues involved with scientific evidence in mass torts to uncertainties, jury incomprehension, partisan scientists and the distortion of evidence caused by the adversarial legal system ('sociologies of error'). Adopting a more symmetrical social constructivist approach to scientific evidence, this paper endeavours to account for some of the complexities in the litigation surrounding the anti-nausea drug Bendectin. Rather than interpret the Bendectin litigation as an instance of the judges eventually valuing the scientific evidence properly, and thus resolving the controversy (the truth winning out), this paper explores the manner in which lawyers, scientists and judges together 'negotiated' a series of cases and judgments which privileged epidemiology as a means of 'resolving' a recurrent socio-legal 'problem'.
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Litigation Life: Law-Science Knowledge Construction in (Bendectin) Mass Toxic Tort Litigation
Social Studies of Science, 2000Co-Authors: Gary Edmond, David MercerAbstract:In recent decades, large-scale product liability litigation, so-called `mass torts', have become increasingly visible on the US legal and political landscape. Invariably, mass tort litigation incor...
Gary Edmond - One of the best experts on this subject based on the ideXlab platform.
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litigation life law science knowledge construction in Bendectin mass toxic tort litigation
Social Studies of Science, 2000Co-Authors: Gary Edmond, David MercerAbstract:In recent decades, large-scale product liability litigation, so-called 'mass torts', have become increasingly visible on the US legal and political landscape. Invariably, mass tort litigation incorporates a range of specialist scientific knowledges. Drawing upon fairly conventional images of law and science, most judges and legal commentators attribute the apparent difficulties encountered in addressing the refractory issues involved with scientific evidence in mass torts to uncertainties, jury incomprehension, partisan scientists and the distortion of evidence caused by the adversarial legal system ('sociologies of error'). Adopting a more symmetrical social constructivist approach to scientific evidence, this paper endeavours to account for some of the complexities in the litigation surrounding the anti-nausea drug Bendectin. Rather than interpret the Bendectin litigation as an instance of the judges eventually valuing the scientific evidence properly, and thus resolving the controversy (the truth winning out), this paper explores the manner in which lawyers, scientists and judges together 'negotiated' a series of cases and judgments which privileged epidemiology as a means of 'resolving' a recurrent socio-legal 'problem'.
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Litigation Life: Law-Science Knowledge Construction in (Bendectin) Mass Toxic Tort Litigation
Social Studies of Science, 2000Co-Authors: Gary Edmond, David MercerAbstract:In recent decades, large-scale product liability litigation, so-called `mass torts', have become increasingly visible on the US legal and political landscape. Invariably, mass tort litigation incor...
Jennifer R. Niebyl - One of the best experts on this subject based on the ideXlab platform.
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doxylamine succinate pyridoxine hydrochloride diclegis for the management of nausea and vomiting in pregnancy an overview
International Journal of Women's Health, 2014Co-Authors: Nina Nuangchamnong, Jennifer R. NiebylAbstract:Nausea and vomiting in pregnancy (NVP) is common and often undertreated, in part due to fears of adverse effects of medications on the fetus during early pregnancy. In April 2013, the US Food and Drug Administration (FDA) approved doxylamine succinate 10 mg and pyridoxine hydrochloride (a vitamin B6 analog) 10 mg as a delayed-release combination pill called Diclegis for the treatment of NVP. Diclegis is currently the only medication that is FDA-approved for the indication of NVP. This review addresses the historical context, safety, efficacy, pharmacology, and practical role of doxylamine and pyridoxine for the management of NVP. The reintroduction of this doxylamine-pyridoxine combination pill into the American market fills a therapeutic gap in the management of NVP left by the removal of the same active drugs marketed over 30 years ago in the form of Bendectin. The substantial amount of safety data accumulated over the years makes it one of the few drugs that qualify for FDA Pregnancy Category A status. In the hierarchical approach to pharmacological treatment of NVP, the combination of doxylamine and pyridoxine should thus be first-tier.
Hylton V. Joffe - One of the best experts on this subject based on the ideXlab platform.
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fda approval of doxylamine pyridoxine therapy for use in pregnancy
The New England Journal of Medicine, 2014Co-Authors: Shelley R. Slaughter, Theresa H. Van Der Vlugt, Rhonda Hearnsstokes, Hylton V. JoffeAbstract:The experience with Bendectin (doxylamine succinate and pyridoxine hydrochloride, for treating nausea and vomiting of pregnancy) reveals how non–science-based decisions may affect the availability of a drug product, with adverse public health consequences.
Navindra Persaud - One of the best experts on this subject based on the ideXlab platform.
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8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information
PloS one, 2017Co-Authors: Rujun Zhang, Navindra PersaudAbstract:OBJECTIVES We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. DESIGN Double blinded, multi-centred, randomized placebo-controlled study. SETTING 14 clinics in the United States. PARTICIPANTS 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. INTERVENTIONS Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. OUTCOMES Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. RESULTS Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. CONCLUSION The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. TRIAL REGISTRATION Not registered.