May 11, 2006
Study suggests no added risk after stopping Vioxx
By Ransdell Pierson and Bill Berkrot
NEW YORK (Reuters) - Merck & Co. said on Thursday that
patients who stopped taking arthritis drug Vioxx for one year
after taking it in an earlier trial had no greater risk of
heart attacks and strokes than patients who took placebos
during the same study.
Vioxx was withdrawn from the market in September 2004 after
the 3-year APPROVe study showed Vioxx doubled the risk of heart
attacks and strokes in those who took it for at least 18
More than 11,500 lawsuits have been filed against Merck by
people, or their survivors, claiming to have been harmed by
Merck general counsel Kenneth Frazier said the follow-up
results should supply a defense against those who blame Vioxx
for heart attacks or strokes suffered after they stopped taking
the drug. "We believe the data does not provide a valid basis
for claims after patients stopped taking the medicine," he told
a conference call.
The company followed patients for another year, as part of
the original APPROVe study design, to assess possible health
consequences for those no longer taking the drug.
While not considered statistically significant, Merck said
28 Vioxx patients had adverse heart events compared with 16 in
the placebo group.
"The data were insufficient to conclude that there was an
increased relative risk of confirmed thrombotic cardiovascular
events following discontinuation of therapy," Merck said.
Some industry analysts believe the Vioxx cases will drag on
for a decade or longer and cost the company billions of dollars
in legal fees and damages.
Merck vows to fight each case on an individual basis,
rather than consider a costly group settlement.
The APPROVe trial enrolled 2,587 patients to see if the
arthritis drug, which worked by controlling inflammation, could
also prevent formation of colon polyps that can cause colon
cancer. Although some patients left the trial before its
conclusion, 1,857 remained for the full 3 years.
During the one-year review period after the dosing stopped,
even those who had taken Vioxx the full 3 years had no
statistically higher risk of heart attack and stroke than those
who took placebos, Merck said.
But a statistically higher risk of heart attacks and
strokes remained in the Vioxx group when taking into
consideration the full 4-year period that included the trial
itself and the subsequent year-long follow-up review.
So far, the Whitehouse Station, New Jersey company has
fought six closely watched Vioxx trials, losing half of them --
including a Texas case where the widow of a Vioxx user was
awarded damages of $243 million. Merck has said it will appeal
all those losing verdicts.
Merck shares edged up 5 cents to $34.56 in after-hours
trading on Inet from their $34.51 New York Stock Exchange