Opinion ID: 1211810
Heading Depth: 2
Heading Rank: 4

Heading: JAMA Article (August 22, 2001)

Text: On August 22, 2001, the Journal of the American Medical Association ( JAMA ) reported the results of a study of Vioxx and Celebrex clinical trials. The JAMA article asserted that available data raised a cautionary flag about the risk of CV events associated with COX-2 inhibitors. App. at 748. It also stated that [c]urrent data would suggest that use of selective COX-2 inhibitors might lead to increased cardiovascular events. App. at 752. The day before that article was published, Bloomberg News reported the statement of a Merck scientist that [w]e already have additional data beyond what they cite, and the findings are very, very reassuring. VIOXX does not result in any increase in cardiovascular events compared to placebo. App. at 539. The JAMA article garnered extensive coverage. Some securities analysts responding to the article on the date of its publication referred to the basic content of the article as not new news, App. at 2749, and noted that the FDA debated many of the same issues in February of this year, at the AAC panel hearing. App. at 2751. The day after the JAMA article's publication, Merck issued a press release stating that it stands behind the overall and cardiovascular safety profile ... of VIOXX. App. at 540. Merck also sent `Dear Doctor' letters to physicians throughout the country disparaging the article as `not based on any new clinical study' and assuring the physicians that Merck `stands behind the overall and cardiovascular safety profile' of VIOXX.' App. at 540.