December 1, 2004

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”

Author Affiliations

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).

JAMA. 2004;292(21):2658-2659. 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.13 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.

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