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Biopharmaceuticals

 News Release - February 22, 2006

Merck Stands Firmly Behind the VIGOR Publication

WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Feb. 22, 2006--Merck & Co., Inc. stands firmly behind the propriety of the scientific analysis and presentation of data in the VIGOR publication, as well as our prompt disclosure of the post-cut-off date events to the U.S. Food and Drug Administration and the medical community. Both the outside authors and Merck authors, in parallel responses published today in the New England Journal of Medicine (NEJM), reaffirm the appropriateness of their scientific analysis of the VIGOR study.

Specifically, the authors noted:
Our evaluation leads us to conclude that our original article followed appropriate clinical trial principles and does not require a correction.(1)

The original table never included the three additional myocardial infarctions because they were not part of the locked database used for the analysis in the VIGOR paper, and the data were not deleted from the manuscript. (2)

There is no material difference in the conclusions that arise from the addition of the events reported after the pre-specified cut-off date for cardiovascular events. (3)

All of the authors stand by the original article, which was written in line with basic clinical trial principles, specifying that data must be analyzed according to plans that are determined before unblinding. (4)
When Merck scientists established the cut-off dates, both they and the outside authors were blinded to the data. The suggestion in the NEJM Reaffirmation that the cut-off dates - established at a time when the data were not known - skewed the results is simply incorrect. Merck could not have known the effect of the cut-off dates because we were blinded to the data. Appropriate clinical trial principles dictate that, once established, the plan must not be changed once the data are unblinded. For that reason, the one stroke reported after the cut-off that occurred on naproxen was also not included in the article, a point not made in the NEJM Reaffirmation.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

(1) BomBardier, et al, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 2

(2) BomBardier, et al, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 2; Reicin and Shapiro, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 3

(3) BomBardier, et al, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 2-3; Reicin and Shapiro, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 3-4

(4) BomBardier, et al, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 2; Reicin and Shapiro, Response to Expression of Concern Regarding VIGOR Study. February 22, 2006 (Accessed February 22, 2006, at http://content.nejm.org/cgi/content/abstract/NEJMc066096), p. 3-4


Source: Merck

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