Anesth Analg 2007; 105:1861-
© 2007 International Anesthesia Research Society
doi: 10.1213/01.ane.0000287630.15745.d1
LETTER TO THE EDITOR
Section Editor:
Lawrence Saidman
The Importance of Transparency in Industry-Sponsored Multicenter Clinical Studies
Paul F. White, PhD, MD, FANZCA
Professor & Margaret Milam McDermott Distinguished Chair of Anesthesiology; Department of Anesthesiology and Pain Management; University of Texas Southwestern Medical Center at Dallas; 5323 Harry Hines Boulevard; Dallas, TX
To the Editor:
The article by Gan et al. (1) describes a comparative multicenter antiemetic prophylaxis study involving a new neurokinin-1 (NK-1) antagonist, aprepitant [Emend]. This drug is the first FDA-approved product in a potentially important new class of antiemetics (2). Unfortunately, the manuscript preparation process raises several issues regarding potential conflict of interest and industry involvement in peer-reviewed publications (3–6).
The University of Texas Southwestern Medical Center at Dallas was the study site (Site 24) that was excluded from the manuscript on the use of aprepitant for prophylaxis against postoperative nausea and vomiting. As the principal investigator at this site, I do not agree with the assessment by Merck personnel that there were significant protocol violations at our site. In fact, a subsequent FDA audit of each case enrolled at our site failed to find any serious protocol violations. Although I recognize Merck’s right to make such decisions for their multicenter trials, this type of action raises a serious question as to the transparency of a multicenter study where the database is completely controlled by the sponsor.
The manuscript that appears in Anesthesia & Analgesia (1) correctly notes that data from our site did not influence the outcome of this study. In fact, the results from our center were exactly the same as the findings from all the other study sites. However, this post hoc analysis was only performed after the issue of the excluded data was raised during the peer-review process. It is the responsibility of the principal academic investigator to oversee the ongoing assessment of all issues that arise in the course of study, as well as to oversee the data analysis and the manuscript preparation process. However, despite being a member of the "Aprepitant Study Group" included on the authorship list, I was not afforded an opportunity to review these data or the manuscript before its submission for publication in Anesthesia & Analgesia. All co-authors should also have been given an opportunity to review the manuscript before its submission to a peer-reviewed medical journal.
A final concern relates to the fact that the study sponsor coordinated the publication process. When lead authors are concurrently involved in promotional activities for the study drug, it is absolutely essential that the publication process be transparent (7–10).
REFERENCES
- Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC. Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg 2007;104:1082–9[Abstract/Free Full Text]
- Gesztesi Z, Scuderi PE, White PF, Wright W, Wender RH, D’Angelo R, Black LS, Dalby PL, MacLean D. Substance P (Neurokinin-1) antagonist prevents postoperative vomiting after abdominal hysterectomy procedures. Anesthesiology 2000;93:931–7[Web of Science][Medline]
- Saidman LJ. Unresolved issues relating to peer review, industry support of research, and conflict of interest. Anesthesiology 1994;80:491–2[Web of Science][Medline]
- Peterson CJ. Industry support of research and conflict of interest. Anesthesiology 1994;81:270[Web of Science][Medline]
- Eger EI. Motivation, bias, and scientific integrity. Anesthesiology 1994;81:270–1[Web of Science][Medline]
- Cullen DJ. Ghostwriting in scientific anesthesia journals. Anesthesiology 1997;87: 195–6[Web of Science][Medline]
- Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, Horton R, KotNicholls, Nylenna M, Overbeke AJ, Sox HC, Van Der Weyden MB, Wilkes MS. Sponsorship, authorship, and accountability. Lancet 2001;358:854–6[Web of Science][Medline]
- Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ, Goldman J, Kassirer JP, Kimball H, Naughton J, Smelser N. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006;295:429–33[Abstract/Free Full Text]
- Moffatt B, Elliott C. Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspect Biol Med 2006;50:18–31[Web of Science]
- Newcombe JP, Kerridge IH. Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Intern Med J 2007;37: 12–17[Web of Science][Medline]
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T. J. Gan, C. C. Apfel, A. Kovac, B. K. Philip, N. Singla, H. Minkowitz, A. S. Habib, A. Carides, K. J. Horgan, J. K. Evans, et al.
The Importance of Transparency in Industry-Sponsored Multicenter Clinical Studies
Anesth. Analg.,
December 1, 2007;
105(6):
1861 - 1862.
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