Cardiologist says Vioxx still a risk after stopping

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)