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Cardiologist says Vioxx still a risk after stopping

Posted on: Friday, 12 May 2006, 17:48 CDT

By Bill Berkrot

NEW YORK (Reuters) - A leading cardiologist on Friday disputed Merck & Co's interpretation on the safety of patients once they stop taking Vioxx, saying they remained at high risk of heart attacks or strokes for some time afterward.

Dr Steven Nissen, interim chairman of cardiology at the prestigious Cleveland Clinic, said Merck misrepresented an analysis of data from a follow-up review of patients involved in the trial that led to the pain medication being pulled from the market.

"It's important that we inform people about this because patients who have taken the drug will need increased surveillance by their physicians and increased awareness of their risks in the year subsequent to stopping the drug. And that risk may extend beyond a year; we simply don't know," Nissen told Reuters in a telephone interview.

Merck said on Thursday that patients who took Vioxx in the study had no greater risk of heart attacks or strokes a year after stopping the medication than those who got placebos.

While there were 28 heart attacks or strokes in the Vioxx group compared with 16 in the placebo group, Merck said those numbers failed to reach statistical significance.

"In the one year after Vioxx was stopped there was a 75 percent greater risk of having an adverse event," Nissen said.

"What this means is that, surprisingly, in the year following discontinuation of Vioxx the relative risk remains approximately as high as it was when people were actually taking the drug. That is very clear from the data," Nissen said.

Merck withdrew Vioxx from the market in September of 2004 after a three-year study showed it doubled the risk of heart attack and strokes in patients taking it for at least 18 months.

Nissen said because there was a relatively small total number of adverse heart events in the follow-up year, Merck was able to claim no statistically significant difference even though the actual numbers tell a different story.

"What is important is that the hazard stays constant even after you stop the drug," Nissen said.

In response to Nissen's comments, Merck said it stands by what it said in Thursday's statement and subsequent conference call.

"We were as transparent as possible in this whole process," Merck spokesman Michael Heinley said. "We were trying to get out as much as we could recognizing there were a lot of people interested in this data."

Merck is facing more than 11,500 lawsuits from people who claim to have been harmed by Vioxx, or their survivors.

The company's general counsel said on Thursday that the one-year follow-up data should shield it from lawsuits that might be filed by people who suffered heart attacks or strokes after they were no longer taking Vioxx.

But Nissen said: "What counts is the relative risk as you go forward, and the bottom line is there is a constant risk even after the drug is stopped.

"That is the only clear message from the study. The rest is spin," he said.

(Additional reporting by Randsell Pierson)

Source: REUTERS

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