Merck Responds to Journal of the American Medical Association Articles
WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. today said it is committed to high standards of scientific integrity and ethics, and believes that many of the comments in a Journal of the American Medical Association (JAMA) news release and in the April 16 issue of JAMA1 related to VIOXX are false, misleading or lack context. The Company said it was not given an opportunity to respond prior to publication. The articles are based on analyses of documents conducted by consultants hired by trial lawyers as part of their work in the VIOXX product liability litigation, and make allegations similar to those previously advanced by these consultants and related attorneys at trial.
"We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal," said Dr. Peter S. Kim, president of Merck Research Laboratories. The Company said a full, unbiased evaluation of the Merck documents shows significant errors in the conclusions put forward by the authors of the JAMA articles.
Merck said it believes that scientific discussion and debate can only be achieved when accurate, factual information is presented, and that is the foundation for its interactions with regulatory agencies and the scientific community. "The allegation that Merck misrepresented mortality data from our Alzheimer's studies is just plain wrong," said Dr. Kim. In fact, the Company said it provided complete mortality data from the Alzheimer's studies to the U.S. Food and Drug Administration, as well as the mortality data from its other studies.
Responding to the assertions about scientific authorship in the JAMA articles Dr. Kim said, "We have explicit policies governing the authorship of papers related to Merck's medicines and vaccines, and we take those policies very seriously. The outside authors of the papers about Merck's clinical trials referenced in the JAMA article were intimately involved in the studies."
The Company said its policies have evolved and become more specific over time, as have the policies of others in the health care field, including those of medical journals. Merck's publication policies are available on www.merck.com.
"Merck remains committed to bringing forward medicines and vaccines that save and improve people's lives," said Dr. Kim. "And we look forward to continuing to engage in constructive, transparent discussions with the broader scientific and medical community about our innovations."
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 risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
1 Catherine D. DeAngelis; Phil B. Fontanarosa. Editorial: Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence. JAMA. 2008;299(15):1833-1835; and Bruce M. Psaty; Richard A. Kronmal. Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From Rofecoxib Litigation JAMA. 2008;299(15):1813-1817; and Joseph S. Ross; Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation. JAMA. 2008;299(15):1800-1812.