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Pharmacy Practice News • December 2009
Ethics [evidence provided]. We just rejected them based on the conclusions not being supported by the data.” It was unknown, Dr. Lipman added, whether the authors of the review articles were working with a vested interest. Similarly, original studies can be scrutinized for inconsistencies in the data or conclusions that aren’t supported, he said. But it’s more difficult, he added, to ferret out problems. “You have to assume the data are legitimate. There is no way to go back and check the source documents.” In its recent author policy up-
date, Pharmacotherapy more strictly defined the various guests and ghosts involved in manuscripts, including ghostwriting, ghostauthorship and guest authorship. It also has updated its conflict-of-interest policy several times in the last two years. Having an outside medical writer
Please see Brief Summary of full Prescribing Information on next page. References: References: 1. 1. Ness Ness P,P, Creer Creer M, M, Rodgers Rodgers GM, GM, et et al; al; the the Recognition, Recognition, Evaluation Evaluation and and Treatment Treatment of of Acquired Acquired Coagulopathy Coagulopathy Consensus Consensus (RETACC) (RETACC) Panel. Panel. Building Building an an immune-mediated immune-mediated coagulopathy coagulopathy consensus: consensus: early early recognition recognition and and evaluation evaluation to to enhance enhance post-surgical post-surgical patient patient safety. safety. Patient Patient Saf Saf Surg. Surg. 2009;3(1):8. 2009;3(1):8. 2. 2. Thrombin-JMI Thrombin-JMI [package [package insert]. insert]. Bristol, Bristol, TN: TN: King King Pharmaceuticals, Pharmaceuticals, Inc.; Inc.; 2007. 2007. 3. 3. Singla Singla NK, NK, Ballard Ballard JL, JL, Moneta Moneta G, G, Randleman Randleman CD CD Jr, Jr, Renkens Renkens KL, KL, Alexander Alexander WA. WA. AA phase phase 3b, 3b, open-label, open-label, single-group single-group immunogenicity immunogenicity and and safety safety study study of of topical topical recombinant recombinant thrombin thrombin inin surgical surgical hemostasis. hemostasis. JJ Am Am Coll Coll Surg. Surg. 2009;209(1):68-74. 2009;209(1):68-74. 4. 4. Chapman Chapman WC, WC, Singla Singla N, N, Genyk Genyk Y,Y, et et al. al. AA phase phase 3,3, randomized, randomized, double-blind double-blind comparative comparative study study of of the the ef¾ ef¾cacy cacy and and safety safety of of topical topical recombinant recombinant human human thrombin thrombin and and bovine bovine thrombin thrombin inin surgical surgical hemostasis. hemostasis. JJ Am Am Coll Coll Surg. Surg. 2007;205(2):256-265. 2007;205(2):256-265. 5. 5. RECOTHROM RECOTHROM [package [package insert]. insert]. Seattle, Seattle, WA: WA: ZymoGenetics, ZymoGenetics, Inc.; Inc.; 2009. 2009. RECOTHROM RECOTHROM isis aa registered registered trademark trademark of of ZymoGenetics, ZymoGenetics, Inc. Inc. ©2009 ©2009 ZymoGenetics, ZymoGenetics, Inc. Inc. All All rights rights reserved. reserved. RT264-00, RT264-00, July July 2009 2009
involved in preparation is not, in and of itself, problematic, Dr. Scheife said. H o w e v e r, t h a t individual should not be a ghost but rather should be listed as an author. That step not only reveals that writer’s involvement, he said, but also requires that, once the individual is identified as an author, they must disclose any related
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conflicts of interest. The line into the problematic “guest” authorship category is crossed when a “ghost” author creates the manuscript and then invites the “guest” author to put his or her name on it with little to no input, Dr. Scheife said. If they do so, “that can never be made right,” he said. Beyond updating its author policy, Pharmacotherapy’s board updated its conflictof-interest policy and revised it twice since, including this fall, when questions were added about any immediate family
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see GHOSTWRITING, page 28