In Vioxx Studies, Merck Used Ghostwriters And Guest Authors

In medical articles and court documents about rofecoxib, it has become
apparent that company employees or another unacknowledged authors were
often involved in writing the clinical trial and review articles, while
primary authorship was awarded to academically affiliated investigators
who may have been only peripherally related to the study. These
documents were examined and published in the April 16, 2008 issue of JAMA.
Rofecoxib is a nonsteroidal anti-inflammatory drug once marketed as
Vioxx by Merck.



In biomedical publication, authorship provides recognition for
scientists' labors, while coincidentally establishing a direction for
accountability and responsibility. A failure to recognize an individual
who has made contributions to the work as an author has been designated
ghostwriting. For those who do not meet authorship criteria of certain
publications, but have still contributed considerably to the research
or writing of a manuscript, guest authorship can be awarded.



According to the authors of this study, "Recent
litigation related to rofecoxib provided a unique opportunity to
examine guest authorship and ghostwriting, practices that have been
suspected in biomedical publication but for which there is little
documentation." Joseph S. Ross, M.D., M.H.S.,
of Mount Sinai School of Medicine, New York, and colleagues performed a
case-study review of court documents in combination with the relevant
medical litreature and publicly available articles from MEDLINE to
describe guest authorship and ghostwriting as related to rofecoxib.
Apprxomiatedly 250 documents were used for this review.



When clinical trials were designed, conducted, and sponsored only by
Merck, documents were found describing affiliated scientists often
working to prepare manuscripts while subsequently recruiting external,
academically affiliated investigators to collaborate as guest authors.
According to the authors of this study, these authors were often placed
in very important positions on the authorship risk. "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." Medical
publishing companies provided almost complete drafts of review
manuscripts to authors for editing in addition to managing all
submissiong and revisions.



Additionally, documents were found describing Merck as compensating
investigators with honorarium for agreeing to serve as authors on
papers that had been ghostwritten for them 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."



The authors indicate that there was a method to Merck's approach in
publishing documents about rofecoxib.  "This
case-study review of industry documents related to rofecoxib
demonstrates that Merck used a systematic strategy to facilitate the
publication of guest authored and ghost written medical literature,"
they write. "We are hopeful that our findings encourage
discussion of ways in which to improve the integrity of research. The
medical profession and the pharmaceutical industry should agree that
collaborations must be conducted with the highest standards. We suggest
that academic researchers consistently provide to the journals the
author contributions for all manuscripts, including original research,
meta-analyses, reviews, and commentaries, and disclose relationships
and support from all industry sources, regardless of the journal's
requirements..



The authors conclude with a call for various methods by which this
situation might be avoided in the future."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."



Guest
Authorship and Ghostwriting in Publications Related to Rofecoxib: A
Case Study of Industry Documents From Rofecoxib Litigation

Joseph S. Ross, MD, MHS; Kevin P. Hill, MD, MHS; David S. Egilman, MD,
MPH; Harlan M. Krumholz, MD, SM

JAMA. 2008;299(15):1800-1812.

Click
Here For Abstract



Written by Anna Sophia McKenney



View drug information on Vioxx.