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(Full text of statement. Contact details below.)
WHITEHOUSE STATION, N.J. (BUSINESS WIRE) Oct 29 - Merck & Co., Inc. today issued the following statement on company documents related to pending VIOXX litigation:
Merck has been informed that the content of documents produced during discovery in pending VIOXX litigation, including documents still under court orders that prohibit their disclosure, have been made public. These documents are pulled from the millions of documents Merck has produced to date during these legal proceedings.
Past experience of other companies in such situations suggests that documents will be deliberately presented out of context to advance the interest of the parties who have started VIOXX litigation. As such, the documents, the surrounding events and the business practices of Merck may well be misinterpreted in any reporting.
None of the documents can obscure the fact that Merck acted responsibly and appropriately as it developed and marketed VIOXX. When questions arose about the safety of VIOXX, Merck took steps to investigate and address these issues.
The company worked diligently with the U.S. Food and Drug Administration and the regulatory authorities in other countries to ensure that the safety profile of VIOXX was reflected appropriately in the prescribing information. Merck also undertook the prospective, randomized, controlled clinical trials that it believed would provide the data to further evaluate the cardiovascular profile of VIOXX. It was in precisely this type of study, the APPROVe trial, in which, for the first time, there was an increased risk of confirmed cardiovascular events beginning after 18 months of treatment in patients taking VIOXX compared to those taking placebo.
Within one week of learning those results, Merck acted in what it believed was the best interest of patients and voluntarily withdrew VIOXX from the market.
Source: HighBeam Research, MERCK ISSUES STATEMENT ON DOCUMENTS RELATED TO VIOXX LITIGATION.