Controversies Section Editor: Phil B. Fontanarosa,
MD, Executive Deputy Editor.
Author Affiliations: Cardiovascular Health
Research Unit, the Departments of Medicine (Dr Psaty), Epidemiology (Drs Psaty
and Weiss), and Health Services (Dr Psaty), University of Washington, Seattle;
Department of Public Health Sciences, Wake Forest University School of Medicine,
Winston-Salem, NC (Dr Furberg); and the Vanderbilt University School of Medicine
and the Geriatric Research, Education, and Clinical Center, Nashville Veterans
Administration Medical Center, Nashville, Tenn (Dr Ray).
Published online November 22, 2004 (doi:10.1001/jama.292.21.2658).
The published literature on drug safety in general and the HMG-CoA reductase
inhibitors (statins) in general is a matter of public record. These publications
have helped to shape our views, and all of us have actively contributed to
the public discussion.1- 3 In
our work with plaintiffs’ attorneys, we reviewed confidential company
documents, and we were bound by protective order to keep this information
confidential unless that information became public through another means,
as indeed some of it did in the Haltom trial. For
our review, we used only publicly available documents. Bayer alone can decide
whether additional documents can or should be made available for public scrutiny.
Psaty BM, Furberg CD, Ray WA, Weiss NS. Authors’ Reply to Bayer’s Response to “Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis”. JAMA. 2004;292(21):2658-2659. doi:10.1001/jama.292.21.2658