From foodconsumer.org
Report: Ghostwriters used in Vioxx studies
By Ben Wasserman
Apr 16, 2008 - 10:42:41 AM
TUESDAY April 15, 2008 (foodconsumer.org) -- A report scheduled to be published Wednesday in the Journal of American Medical Association says that Merck has ghostwritten dozens of articles on vioxx studies and then given them to prestigious doctors for their signatures before publication, The New York Times reported.
The medical industry is known to have been using ghostwriters to write the trial reports on trials and other medial studies. Many authors are not real writers of the papers that bear their names.
But the Times said that this report "provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals."
The report was authored by Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York and Dr. David S. Egilman, a clinical associate medical professor at Brown University who served as consultants to plaintiffs' lawyers in some vioxx suits and had access to many documents provided by Merck, the defendant in the suits.
Merck acknowledged that the company at times let its employees to write draft reports and then ask doctors to finalize the reports for publication.
The Vioxx maker rejected the labeling of its employees' writing as ghostwriting and some "outsider authors" whose names appear in the questionable research papers defended their roles.
Dr. Steven H. Ferris, a New York University psychiatry professor, whose name was not present in the draft paper of a study, but later showed up in the final draft, said the notion that the paper bearing his name was ghostwritten was "simply false", according to the Times. He claimed he did his share of research and revised the draft.
But according to the Times, Merck did hire professional ghostwriters. Scientific Therapeutics, a medical writing company based in New York, seemed working on eight different reports at a time for Merck.
At least one of the papers the writing company's working on was being aimed at the Journal of the American medical Association, according to a letter dated October 2000, cited by the Times’ report. The study ended up in the journal in Jan 2002, but never disclosed the role of the ghostwriter.
"It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician,” Dr. Ross was quoted as saying.
Dr. Ross was cited as saying what are concerning are not the authorship of drug research studies, but the validity of the clinical trial on which the research is based.
"Who designed the trial? Who did the trial? Who did the analysis? Who interpreted the analysis?" The times quoted Dr. Ross as saying.
In an editorial accompanying the article, the editorialist said the analysis showed that Merck had influenced dozens of publications to promote Vioxx.
"It is clear that at least some of the authors played little direct roles in the study of review, yet still allowed themselves to be named as authors," the editorialist was quoted as saying.
The following is what Dr. Ross and colleagues found cited from a news release by JAMA and Archives Journals:
When publishing their own clinical trials (designed, conducted, and sponsored by Merck), documents were found describing Merck scientists often working to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to collaborate on the manuscript as guest authors.
"Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors," the researchers write.
Documents indicated that medical publishing companies provided near complete drafts of review manuscripts to authors for editing, in addition to managing submissions and revisions.
Documents were also found describing Merck compensating investigators with honorarium for agreeing to serve as authors on review manuscripts ghostwritten on their behalf by medical publishing companies.
"Among 96 relevant published articles, we found that 92 percent (22 of 24) of clinical trial articles published a disclosure of Merck’s financial support, but only 50 percent (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company."
"This case-study review of industry documents related to rofecoxib (vioxx) demonstrates that Merck used a systematic strategy to facilitate the publication of guest authored and ghost written medical literature," the authors write.
"Authors who 'sign-off' on or 'edit' original manuscripts or reviews written explicitly by pharmaceutical industry employees or by medical publishing companies should offer full authorship disclosure, such as, 'drafting of the manuscript was done by representatives from XYZ, Inc.; the authors were responsible for critical revisions of the manuscript for important intellectual content.' A coordinated oversight strategy involving academic physicians, journal editors, and industry representatives is necessary to discourage both guest authorship and ghostwriting and improve the integrity of the biomedical authorship system," the authors conclude.