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”
- Bruce M. Psaty, MD, PhD;
- Curt D. Furberg, MD, PhD;
- Wayne A. Ray, PhD;
- Noel S. Weiss, MD, DrPH
- Corresponding Author: Bruce M. Psaty, MD, PhD, Cardiovascular Health Research Unit, Suite 1360, 1730 Minor Ave, Seattle, WA 98101 (psaty{at}u.washington.edu).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- CERIVASTATIN
- CONFLICT OF INTEREST
- CONTROVERSIES (FONTANAROSA PB, ED)
- DRUG REACTION, ADVERSE
- DRUG INDUSTRY
- HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS
- RHABDOMYOLYSIS
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.
In terms of cerivastatin and the risk of rhabdomyolysis, the key questions are when did the spontaneous adverse event reports unequivocally suggest an increased risk of rhabdomyolysis, and how long was it from then …
