The two popular painkillers
Vioxx and Celebrex, heavily marketed as "super-aspirin,"
were prescribed for millions of patients who did not
need them or should not have taken them, researchers
said.
Merck & Co. Inc's Vioxx
was recalled in September because a study linked the
drug to increased risk of heart attacks and strokes,
while Pfizer's Celebrex is under a cloud after data
showing a similar heightened risk.
The study by doctors
at Stanford University and the University of Chicago
found the two COX-2 inhibitors were taken by millions
of people who were not at risk of gastrointestinal bleeding,
the main reason patients were told to switch from aspirin
and other lower-cost painkillers.
COX-2 inhibitors cost
10 to 15 times as much as the drugs they replaced, the
study published in the Archives of Internal Medicine
said.
"We found a rapid, nationwide
shift away from older, inexpensive drugs with better
established safety and efficacy to newer, costly drugs
with no real history," said study author G. Caleb Alexander,
a medical ethicist at the University of Chicago.
Within a year of being
introduced in 1999, Vioxx and Celebrex were being heavily
promoted as "super-aspirin" and bringing in billions
of dollars in revenue annually, the study said. Merck
spent $161 million in 2000 on direct-to-consumer
marketing of Vioxx, it said.
Using data from the National
Center for Health Statistics, the study concluded that
73 percent of patients considered at low or very low
risk of gastrointestinal problems should not have been
considered for the newer drugs. Gastrointestinal bleeding
usually affects only at-risk patients who must take
aspirin and other non-steroidal anti-inflammatory drugs,
or NSAIDs, for long periods, it said.
By 2002, 17.6 million
patients at low risk of gastrointestinal bleeding, or
66 percent of those patients, were taking one of the
two COX-2 inhibitors, the study said.
The drugs were also taken
by millions of people who should not have been, including
16 million people suffering from congestive heart failure,
or liver or kidney dysfunction. These patients might
also have been hurt by NSAIDs, it said.
"The findings demonstrate
the challenge of limiting innovative therapies to the
settings in which they are initially targeted and maximally
cost-effective," Alexander wrote.
The U.S. Food and Drug
Administration is convening a panel next month to examine
the COX-2 inhibitors, including Pfizer's new entry Bextra,
which has also been found to raise the risk of heart
attack in people who have had heart bypass surgery.
Spokesmen for Pfizer
and Merck could not immediately comment.