Taking Pains: The Vioxx Role Play
Documents
- 11.26.96-Memo re Risk:
This internal memorandum suggests that Merck scientists understood the cardiovascular risk associated with Vioxx as early as November 1996. - 3.10.00-EMFReicin.Vigor
An internal e-mail indicates that a Merck researcher believes that cardiovascular effects are "clearly there," after VIGOR study. The implications of this e-mail are in dispute, one side saying Merck knew about the CV effect, the other side saying this is merely conversation between scientists about possible impact of the effect. - 3.28.00-EMFReicin.Expert
An internal e-mail suggests that a Merck researcher checked with an international expert who denied that the cardiovascular effect shown in VIGOR was the result of the protective effect of naproxen. The implications of this e-mail are in dispute, one side claiming it shows Merck lied about its assessment of the VIGOR study to avoid warning partients about CV effects, the other side saying this is merely conversation between scientists about possible reasons for the effect. - 5.22.01-MerckPR.Vioxx Safe
This Merck press release says that Vioxx use is not associated with cardiovascular risk. - FDAWarningLetter-09-17-2001
FDA letter to Merck objecting to Merck's representations concerning Vioxx's safety profile. - Graham Testimony
November 18, 2004, testimony before Congressional subcommittee by David Graham, M.D., MPH, Associate Director for Science and Medicine in FDA’s Office of Drug Safety - 2.26.05-EMFReicin
This is an internal Merck e-mail that reflects an understanding that there are cardiovascular effects of the test medication during one of the Vioxx drug trials. - Dodgeball
This is training material for Merck Sales Staff meant to train them on overcoming obstacles. Pay particular attention to pages 4, 5, 35, 36, 37. One side claims Merck was training its salespeople to avoid questions about cardiovascular risk, the other side says that the information is accurate, but the choosing the title "Dodgeball" was unfortunate. - APPROVe Study
This is the clinical trial article that identified the increased cardiovascular risk in Vioxx users. - APPROVe Table 2
This is a magnification of an important table in the APPROVe Study. - VIGORArticle-NEJM
This is the clinical trial report that initially suggested that Vioxx use had a negative cardiovascular effect. - 10-04-06 JAMA Article
Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials, Journal of the American Medical Association, (Reprinted) JAMA, October 4, 2006—Vol 296, No. 13, 1619: This is the study that suggests cardiac effects are particular to Vioxx and may arise earlier than 18 months.