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Ethics in Biology, Engineering and Medicine: An International Journal
SJR: 0.123

ISSN Imprimir: 2151-805X
ISSN On-line: 2151-8068

Ethics in Biology, Engineering and Medicine: An International Journal

DOI: 10.1615/EthicsBiologyEngMed.2015013276
pages 259-269

Conflict of Interest Disclosure in Orphan Drug Research

Daniel Patrone
Department of Philosophy, State University of New York, College at Oneonta, Oneonta, New York
Jen-Ting Wang
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York
Melissa Haig
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York
Rosemary Harris
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York
Rebecca LeFebvre
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York
Matthew Vedete
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York
Taylor Zelka
Department of Mathematics, Computer Science and Statistics, SUNY Oneonta, Oneonta, New York

RESUMO

Full and consistent disclosure of conflicts of interest (COIs) is especially important in literature dealing with orphan drugs, that is, drugs that are developed to treat specific rare diseases or conditions. Yet little attention has been paid to COI policies and practices in research dealing with orphan drugs, even though several considerations might argue for heightened scrutiny of COI reporting in this field. Sponsors of drugs that qualify for orphan status benefit from considerable incentives for developing these products, while the development of such drugs also can carry significant professional and financial risks. Trust in the research process in general, and in the federally funded orphan drug program in particular, depends on researcher transparency about financial ties between authors and industry. Recent controversies have also shed light on the role that medical journal publication can play in the promotion of off-label use of orphan drugs, raising important issues of trust and safety. To examine the rate and consistency of researcher disclosure of COIs, we identified eight orphan drugs approved for the first time in 2009 and examined the author-reported COI statements in journal articles discussing these drugs that were published in English within 36 months of each respective drug's approval. This resulted in 346 articles listing 1,969 authors (1,517 total unique authors). While we observed much higher overall rates of disclosure than were reported in prior studies, we did find patterns of inconsistent disclosure among authors listed in more than one article, particularly among authors who disclosed ownership COIs in at least one of their articles. This paper discusses these findings and considers the unique importance of COI disclosure within the financial and regulatory contexts of research involving orphan drugs.


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