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Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation

BACKGROUND: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. Th...

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Autores principales: Vedula, S Swaroop, Goldman, Palko S, Rona, Ilyas J, Greene, Thomas M, Dickersin, Kay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3439687/
https://www.ncbi.nlm.nih.gov/pubmed/22888801
http://dx.doi.org/10.1186/1745-6215-13-136
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author Vedula, S Swaroop
Goldman, Palko S
Rona, Ilyas J
Greene, Thomas M
Dickersin, Kay
author_facet Vedula, S Swaroop
Goldman, Palko S
Rona, Ilyas J
Greene, Thomas M
Dickersin, Kay
author_sort Vedula, S Swaroop
collection PubMed
description BACKGROUND: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin®, Pfizer, Inc.): migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. METHODS: We included in this study internal company documents, email correspondence, memoranda, study protocols and reports that were made publicly available in 2008 as part of litigation brought by consumers and health insurers against Pfizer for fraudulent sales practices in its marketing of gabapentin (see http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf for the Court’s findings). We reviewed documents pertaining to 20 clinical trials, 12 of which were published. We categorized our observations related to reporting biases and linked them with topics covered in internal documents, that is, deciding what should and should not be published and how to spin the study findings (re-framing study results to explain away unfavorable findings or to emphasize favorable findings); and where and when findings should be published and by whom. RESULTS: We present extracts from internal company marketing assessments recommending that Pfizer and Parke-Davis (Pfizer acquired Parke-Davis in 2000) adopt a publication strategy to conduct trials and disseminate trial findings for unapproved uses rather than an indication strategy to obtain regulatory approval. We show internal company email correspondence and documents revealing how publication content was influenced and spin was applied; how the company selected where trial findings would be presented or published; how publication of study results was delayed; and the role of ghost authorship. CONCLUSIONS: Taken together, the extracts we present from internal company documents illustrate implementation of a strategy at odds with unbiased study conduct and dissemination. Our findings suggest that Pfizer and Parke-Davis’s publication strategy had the potential to distort the scientific literature, and thus misinform healthcare decision-makers.
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spelling pubmed-34396872012-09-13 Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation Vedula, S Swaroop Goldman, Palko S Rona, Ilyas J Greene, Thomas M Dickersin, Kay Trials Research BACKGROUND: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin®, Pfizer, Inc.): migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. METHODS: We included in this study internal company documents, email correspondence, memoranda, study protocols and reports that were made publicly available in 2008 as part of litigation brought by consumers and health insurers against Pfizer for fraudulent sales practices in its marketing of gabapentin (see http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf for the Court’s findings). We reviewed documents pertaining to 20 clinical trials, 12 of which were published. We categorized our observations related to reporting biases and linked them with topics covered in internal documents, that is, deciding what should and should not be published and how to spin the study findings (re-framing study results to explain away unfavorable findings or to emphasize favorable findings); and where and when findings should be published and by whom. RESULTS: We present extracts from internal company marketing assessments recommending that Pfizer and Parke-Davis (Pfizer acquired Parke-Davis in 2000) adopt a publication strategy to conduct trials and disseminate trial findings for unapproved uses rather than an indication strategy to obtain regulatory approval. We show internal company email correspondence and documents revealing how publication content was influenced and spin was applied; how the company selected where trial findings would be presented or published; how publication of study results was delayed; and the role of ghost authorship. CONCLUSIONS: Taken together, the extracts we present from internal company documents illustrate implementation of a strategy at odds with unbiased study conduct and dissemination. Our findings suggest that Pfizer and Parke-Davis’s publication strategy had the potential to distort the scientific literature, and thus misinform healthcare decision-makers. BioMed Central 2012-08-13 /pmc/articles/PMC3439687/ /pubmed/22888801 http://dx.doi.org/10.1186/1745-6215-13-136 Text en Copyright ©2012 Vedula et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Vedula, S Swaroop
Goldman, Palko S
Rona, Ilyas J
Greene, Thomas M
Dickersin, Kay
Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title_full Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title_fullStr Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title_full_unstemmed Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title_short Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin® litigation
title_sort implementation of a publication strategy in the context of reporting biases. a case study based on new documents from neurontin® litigation
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3439687/
https://www.ncbi.nlm.nih.gov/pubmed/22888801
http://dx.doi.org/10.1186/1745-6215-13-136
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