Vioxx Short-Term Risk not seen in other Data

posted on:
July 3, 2007

author:
Staff

NEW YORK (Reuters) – A lawyer who represents Merck & Co. in its litigation over Vioxx said on Tuesday that an unpublished study that reportedly shows heart risks with the withdrawn painkiller in short-term use is not supported by other data.

Merck withdrew Vioxx from the market in September 2004 after a study showed the one-time $2.5 billion-a-year drug doubled the risk of heart problems after 18 months of use. The company has since argued in trials that there is no evidence that short-term use increased heart risks.

But a new study approved for publication in the New England Journal of Medicine says half of patients who experienced cardiovascular events did so within 12 months, the Wall Street Journal reported. Risk of heart attack and stroke went away within 14 days after patients stopped taking the drug, according to the report.

Ted Mayer, outside counsel for Merck in the Vioxx litigation, said, "We will wait until publication of the study before going into detail about what the data show or do not show."

"The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx," Mayer said in a statement.

A spokeswoman for the New England Journal of Medicine said she could not confirm or deny that it is publishing any study.

Merck shares were about 0.6 percent higher in midday trading.

The new study, known as Victor, was conducted by researchers at Oxford University in England, the Journal said.

Kent Jarrell, a spokesman for Merck's litigation team, said the preliminary data already had been presented in October 2006 at the annual conference of the National Cancer Research Institute.

"We don't think it will have a significant effect" on the litigation, Jarrell said of the study.

It was unclear whether the Victor study has been subjected to the scrutiny that is necessary for publication in the medical journal. Under such a peer-review process, other experts look for flaws in the research.

Morgan Stanley analyst Jami Rubin said in a research note that plaintiff attorneys have had data from the study since 2005, "woven into the 15 Vioxx cases that have already gone to trial with little to no impact on jurors' decisions."

Rubin also said the data was discussed at a U.S. Food and Drug Administration meeting in February 2005.

Merck faced more than 27,000 product liability lawsuits over Vioxx as of March 31, and has said it will try each case individually rather than seek to enter into a broad settlement.

The New Jersey-based drugmaker so far has won nine cases that have gone to trial and lost five. In another case the verdict was overturned by judge, and it will be retried.

"We continue to believe that Vioxx liability risk is manageable and likely significantly lower than our $15 billion future value liability forecast baked into our valuation framework," Rubin said.

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