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August 27, 2008

Guest Authorship, Mortality Reporting, and Integrity in Rofecoxib Studies—Reply

JAMA. 2008;300(8):900-906. doi:10.1001/jama.300.8.904-c

In Reply: Drs FitzGerald, Patrono, and Hawkey write that review papers they authored were inappropriately included in the Table in our article, explaining that their articles were independently authored without discussion of their content with Merck before publication. The Table, as stated in its legend and in the text of the article, includes articles identified from internal documents,1,2 as well as other articles by investigators identified within internal documents. Articles by such investigators were found by searching MEDLINE, as we described. All of these articles were examined to better understand patterns of disclosure, as we believed that either their mention within internal documents or the mention of specific investigators suggested that Merck was aware of the publication and perhaps had provided support for the project. Correspondence with Merck, acknowledged by FitzGerald and Patrono, led to the identification of their articles using MEDLINE. To our knowledge, these articles were not discussed with medical publishing companies and no such claims were made within our study. Hawkey was identified from a publication status report that proposed him as a first author of 1 clinical trial and 1 review article and designated a Merck employee as author of the manuscripts' first drafts.1 We identified both articles using MEDLINE,3,4 as well as 2 other clinical trial articles and the 4 review manuscripts in question.

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