Report: Merck not at fault with Vioxx

Sept. 6, 2006 at 6:34 PM
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NEW YORK, Sept. 6 (UPI) -- A special committee of U.S. firm Merck's board of directors has released a report of a 20-month probe of Merck's Vioxx-related conduct.

And that report finds Merck did nothing wrong.

The report by The Honorable John Martin Jr. of Debevoise & Plimpton was a result of an investigation into the "integrity of Merck's senior management in the development, testing and marketing of Vioxx (rofecoxib)."

The company withdrew the COX 2 inhibitor painkiller in September 2004 after studies showed a higher cardiac risk in patients using the drug long term.

"The 'Martin Report,' while not endorsing every action that Merck employees took with respect to Vioxx, found that Merck's senior management acted with integrity," said Debevoise & Plimpton in a statement issued Wednesday.

Key findings from the report include:

-- There is no basis for the suggestion made by critics that Merck scientists believed that Vioxx posed or was likely to pose a cardiovascular risk prior to its approval by the FDA.

-- In March 2000 Merck scientists responded appropriately to cardiovascular data from a clinical trial (called the VIGOR Trial) and reasonably determined, after substantial scientific inquiry, that the comparator agent in the trial, naproxen, likely had conferred a cardioprotective effect and that Vioxx likely had not caused cardiovascular events.

-- Merck disclosed all clinical trial data to the FDA.

-- Merck scientists continually generated, collected and analyzed data bearing on the cardiovascular safety of Vioxx. Their review of the data did not reveal a difference in the relative risk of Vioxx compared to placebo until the APPROVe Trial data were unblinded in late September 2004, at which point Merck immediately withdrew the drug.

The Martin Report also contained criticisms of some acts by Merck employees, including "certain interactions with academic scientists who were critical of Merck and Vioxx, the clarity of certain public statements by Merck concerning Vioxx, and use of a promotional aid by sales representatives after the VIGOR Trial cardiovascular data were unblinded that did not, standing alone, provide all of the available cardiovascular data on Vioxx."

"Our investigation did find instances of poor judgment and errors, but it is important to note that they were not made with intent to deceive," Judge Martin said.

Merck's board of directors created the Special Committee in December 2004, which in turn retained Judge Martin and the firm Debevoise & Plimpton to conduct the investigation and issue a report.

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